Colace is a stool softener. It makes bowel movements softer and easier to pass.

Colace is used to treat or prevent occasional constipation, and to reduce pain or rectal damage caused by hard stools or by straining during bowel movements.

Colace may also be used for purposes not listed in this medication guide.

Warnings

You should not use Colace if you have a blockage in your intestines.

Do not use Colace while you are sick with nausea, vomiting, or severe stomach pain.

You should not use docusate if you also use mineral oil, unless your doctor tells you to.

Before taking this medicine

You should not use Colace if you are allergic to docusate.

Ask a doctor or pharmacist if this medicine is safe to use if you have:

• stomach pain;
• nausea;
• vomiting; or
• a sudden change in bowel habits that lasts over 2 weeks.

Ask a doctor before using this medicine if you are pregnant or breastfeeding.

Do not give this medicine to a child without medical advice.

How should I use Colace?

Use Colace exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Take this medicine with a full glass of water. Drink plenty of liquids while you are taking this medicine.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.

Colace generally produces bowel movement in 12 to 72 hours. Call your doctor if your symptoms do not improve after 72 hours.

You should not use this medicine for longer than 1 week, unless your doctor tells you to. Call your doctor if your symptoms do not improve, or if you have not had a bowel movement within 1 to 3 days. Overuse of a stool softener can lead to serious medical problems.

Store at room temperature away from moisture, light, and heat. Do not freeze liquid medicine.

Dosing information

Usual Adult Dose for Constipation:

50 to 300 mg daily divided in 1 to 4 doses each day.

Usual Pediatric Dose for Constipation:

Less than 2 years: Check with your doctor.

2 to 12 years: 50 to 150 mg daily divided in 1 to 4 doses each day.

What happens if I miss a dose?

Since Colace is used when needed, you may not be on a dosing schedule. Skip any missed dose if it’s almost time for your next dose. Do not use two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line.

What should I avoid while using Colace?

Avoid using mineral oil, unless told to do so by a doctor.

Colace side effects

Get emergency medical help if you have signs of an allergic reaction to Colace : hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using this medicine and call your doctor at once if:

• you have rectal bleeding;
• no bowel movement occurs after using a laxative;
• you need to use a stool softener for more than 1 week; or
• if a rash occurs.

Less serious Colace side effects may be more likely, and you may have none at all.

This is not a complete list of side effects and others may occur.

CONTRAINDICATIONS The HalfLytely and Bisacodyl Tablets Bowel Prep Kit is contraindicated in the following conditions: •Known allergies to polyethylene glycol or other components of the kit •Gastrointestinal (GI) obstruction •Bowel perforation •Toxic colitis •Toxic megacolon Toxic megacolon (4)

Warnings and Precautions

There have been reports of generalized tonic-clonic seizures in patients with use of large volume (4 liter) PEG-based colon preparation products in patients with no prior history of seizures. The seizure cases were associated with severe vomiting, excessive beverage consumption and electrolyte abnormalities (for example, hyponatremia, hypokalemia). The neurologic abnormalities resolved with correction of fluid and electrolyte abnormalities. Therefore, HalfLytely and Bisacodyl Tablets Bowel Prep Kit should be used with caution in patients using concomitant medications (such as diuretics) that increase the risk of electrolyte abnormalities or patients with known or suspected hyponatremia. Monitor baseline and post-colonoscopy laboratory tests (sodium, potassium, calcium, creatinine, and BUN) in these patients.

Warnings

There have been reports of generalized tonic-clonic seizures in patients with use of large volume (4 liter) PEG-based colon preparation products in patients with no prior history of seizures. The seizure cases were associated with severe vomiting, excessive beverage consumption and electrolyte abnormalities (for example, hyponatremia, hypokalemia). The neurologic abnormalities resolved with correction of fluid and electrolyte abnormalities. Therefore, HalfLytely and Bisacodyl Tablets Bowel Prep Kit should be used with caution in patients using concomitant medications (such as diuretics) that increase the risk of electrolyte abnormalities or patients with known or suspected hyponatremia. Monitor baseline and post-colonoscopy laboratory tests (sodium, potassium, calcium, creatinine, and BUN) in these patients.

Precautions

PRECAUTIONS Neurologic (5.1)Gastrointestinal There have been reports of generalized tonic-clonic seizures in patients with use of large volume (4 liter) PEG-based colon preparation products in patients with no prior history of seizures. The seizure cases were associated with severe vomiting, excessive beverage consumption and electrolyte abnormalities (for example, hyponatremia, hypokalemia). The neurologic abnormalities resolved with correction of fluid and electrolyte abnormalities. Therefore, HalfLytely and Bisacodyl Tablets Bowel Prep Kit should be used with caution in patients using concomitant medications (such as diuretics) that increase the risk of electrolyte abnormalities or patients with known or suspected hyponatremia. Monitor baseline and post-colonoscopy laboratory tests (sodium, potassium, calcium, creatinine, and BUN) in these patients. (5.2) Renal Insufficiency Use with caution in patient with severe ulcerative colitis, ileus or gastric retention. Observe patients with impaired gag reflex and patients prone to regurgitation or aspiration during administration of HalfLytely solution. If GI obstruction or perforation is suspected, appropriate studies should be performed to rule out these conditions before administration. There have been reports of ischemic colitis in patients with use of HalfLytely and 20 mg Bisacodyl Tablets Bowel Prep Kit. If patients develop severe abdominal pain or rectal bleeding, patients should be evaluated as soon as possible. (5.3) Allergic Reaction Patients with impaired water handling who experience severe vomiting should be closely monitored including measurement of electrolytes (sodium, potassium, calcium, BUN and creatinine). (5.4)Allergic Reaction Hives and skin rashes have been reported with PEG-3350 based products which are suggestive of an allergic reaction.

Adverse Reactions/Side Effects

ADVERSE REACTIONS Most common adverse reactions (< 3%) are abdominal pain/cramping, nausea,vomiting and headache (6)To report SUSPECTED ADVERSE REACTIONS, contact BraintreeLaboratories, Inc.

Drug Interactions

DRUG INTERACTIONS
Oral medication administered within one hour of the start of administrationof HalfLytely solution may be flushed from the GI tract and the medicationmay not be absorbed. (7)
Do not take the bisacodyl delayed release tablets within one hour of takingan antacid. (7)See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labelingRevised: 10/2007
FULL PRESCRIBING INFORMATION: CONTENTS *
1 INDICATIONS AND USAGE2 DOSAGE AND ADMINISTRATION3 DOSAGE FORMS AND STRENGTHS4 CONTRAINDICATIONS5 WARNINGS AND PRECAUTIONS5.
1 Neurologic
2 Gastrointestina
3 Renal Insufficiency

4 Allergic Reaction
5 ADVERSE REACTIONS

Clinical Studies

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in clinical studies of another drug and may not reflect the rates observed in practice. In a clinical study of HalfLytely and (10 mg vs. 20 mg) Bisacodyl Tablets Bowel Prep Kit multicentered, controlled clinical trials, abdominal pain/cramping, nausea, vomiting and headache were the most common adverse reactions ( 3%) after the administration of HalfLytely and (10 mg or 20 mg) Bisacodyl Tablets Bowel Prep Kit. Less than 1% of patients exposed to HalfLytely and 10 mg Bisacodyl Tablets Bowel Prep Kit reported vomiting and abdominal pain/cramping. The data in reflects exposure in 222 patients to HalfLytely and 10 mg bisacodyl tablets vs. 223 patients exposed to HalfLytely and 20 mg bisacodyl tablets. The HalfLytely and 10 mg Bisacodyl Tablets Bowel Prep Kit population was 20-85 years of age, 46% male, 54% female, 10% African American, 85% Caucasian, 8% Hispanic requiring a colonoscopy. The demographics of the comparator group were similar.

Use In Specific Populations

8.1 Pregnancy Pregnancy Category C. Animal reproduction studies have not been conducted. It is not known whether HalfLytely and Bisacodyl Tablets Bowel Prep Kit can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. HalfLytely and Bisacodyl Tablets Bowel Prep Kit should be given to a pregnant or nursing woman only if clearly needed. 8.3 Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when HalfLytely and Bisacodyl Tablets Bowel Prep Kit is administered to a nursing woman. 8.4 Pediatric Use Safety and effectiveness in pediatric patients has not been established. 8.5 Geriatric Use Of the 222 patients who received HalfLytely and 10 mg Bisacodyl Tablets Bowel Prep Kit in clinical trials, 73 (33%) were 65 years of age or older, while 18 (8%) were 75 years of age or older. No overall differences in safety or effectiveness were observed between geriatric patients and younger patients, and other reported clinical experience has not identified differences in responses between geriatric patients and younger patients but greater sensitivity of some older individuals cannot be ruled out.

PREGNANCY

Pregnancy Category C. Animal reproduction studies have not been conducted. It is not known whether HalfLytely and Bisacodyl Tablets Bowel Prep Kit can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. HalfLytely and Bisacodyl Tablets Bowel Prep Kit should be given to a pregnant or nursing woman only if clearly needed

NURSING MOTHERS

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when HalfLytely and Bisacodyl Tablets Bowel Prep Kit is administered to a nursing woman.

PEDIATRIC USE

Safety and effectiveness in pediatric patients has not been established

GERIATRIC USE

Of the 222 patients who received HalfLytely and 10 mg Bisacodyl Tablets Bowel Prep Kit in clinical trials, 73 (33%) were 65 years of age or older, while 18 (8%) were 75 years of age or older. No overall differences in safety or effectiveness were observed between geriatric patients and younger patients, and other reported clinical experience has not identified differences in responses between geriatric patients and younger patients but greater sensitivity of some older individuals cannot be ruled out.

Bisacodyl Description

Each HalfLytely and Bisacodyl Tablets Bowel Prep Kit [Polyethylene glycol (PEG) 3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution and bisacodyl delayed release tablets] consists of one 2 liter bottle of HalfLytely (PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution) powder for reconstitution and two 5 mg bisacodyl, delayed release tablets.
•Bisacodyl delayed release tablets: Each pink, round, enteric coated bisacodyl delayed release tablet (stamped “BRA”) contains 5 mg of bisacodyl, USP (C22H19NO4) with a molecular weight of 361.40.
Inactive ingredients include lactose (anhydrous) NF, microcrystalline cellulose NF, croscarmellose sodium NF, magnesium stearate NF, Eudragit L 30-55, polyethylene glycol 400, talc USP, gelatin, calcium sulfate (anhydrous) NF, confectioners sugar, kaolin USP, sucrose NF, Opalux pink, beeswax, and carnauba wax.
The bisacodyl delayed release tablets are administered orally prior to drinking the HalfLytely solution [see Dosage and Administration
( 2)].
•HalfLytely (PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution): A white powder for reconstitution containing 210 grams of PEG-3350, 2.86 grams of sodium bicarbonate, 5.6 grams of sodium chloride, 0.74 grams of potassium chloride and 1 gram of flavoring ingredient (if applicable). Flavor Packs are available in Cherry, Lemon-Lime and Orange. This preparation can be used without the addition of a Flavor Pack. When dissolved in water to a volume of 2 liters, the HalfLytely solution is isosmotic, clear, and colorless. The HalfLytely solution is administered orally after taking the two bisacodyl delayed release tablets [see Dosage and Administration
( 2)].

Bisacodyl – Clinical Pharmacology

12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action HalfLytely and Bisacodyl Tablets Bowel Prep Kit induces diarrhea which cleanses the colon. 12.2 Pharmacodynamics Bisacodyl, a stimulant laxative, is hydrolyzed by intestinal brush border enzymes and colonic bacteria to form an active metabolite [bis-(p-hydroxyphenyl) pyridyl-2 methane; (BHPM)] that acts directly on the colonic mucosa to produce colonic peristalsis. 12.3 Pharmacokinetics The osmotic activity of HalfLytely solution results in no net absorption or excretion of ions or water.

MECHANISM OF ACTION

HalfLytely and Bisacodyl Tablets Bowel Prep Kit induces diarrhea which cleanses the colon

PHARMACODYNAMICS

Bisacodyl, a stimulant laxative, is hydrolyzed by intestinal brush border enzymes and colonic bacteria to form an active metabolite [bis-(p-hydroxyphenyl) pyridyl-2 methane; (BHPM)] that acts directly on the colonic mucosa to produce colonic peristalsis.

PHARMACOKINETICS

The osmotic activity of HalfLytely solution results in no net absorption or excretion of ions or water.

Nonclinical Toxicology

13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term studies in animals have not been performed to evaluate the carcinogenic potential of HalfLytely and Bisacodyl Tablets Bowel Prep Kit. Studies to evaluate its potential for impairment of fertility or its mutagenic potential have not been performed.

How is Bisacodyl supplied

Each HalfLytely and Bisacodyl Tablets Bowel Prep Kit contains:
One pack of bisacodyl delayed release tablets containing two pink, round, enteric coated 5 mg bisacodyl delayed release tablets, stamped “BRA”
One 2 liter bottle of HalfLytely (PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution) powder for reconstitution containing 210 grams of polyethylene glycol (PEG) 3350, 2.86 grams of sodium bicarbonate, 5.6 grams of sodium chloride, 0.74 grams of potassium chloride, and 1 gram of flavoring ingredient (if applicable). After adding 2 liters of water, the reconstituted HalfLytely solution (clear and colorless) contains 31.3 mmol/L of PEG-3350, 65 mmol/L of sodium, 53 mmol/L of chloride, 17 mmol/L of bicarbonate and 5 mmol/L of potassium.
Lemon-Lime HalfLytely and Bisacodyl Tablets Bowel Prep Kit contains 1 gram lemon-lime flavoring ingredient. HalfLytely and
Bisacodyl Tablets Bowel Prep Kit with Flavor Packs contains 3 packs (1 gram each Cherry, Lemon-Lime and Orange flavors).
Storage: Store at 20-25°C (68-77°F). Excursions permitted between 15-30°C (59-86°F). The reconstituted HalfLytely solution, which may be refrigerated, should be used within 48 hours. Lemon-Lime HalfLytely and Bisacodyl Tablets

Storage and Handling

STORAGE AND HANDLING17
PATIENT COUNSELING INFORMATION17.4 FDA-Approved Patient Labeling * Sections or subsections omitted from the full prescribing information are not listed page 2 of 6 FULL PRESCRIBING INFORMATION1 INDICATIONS AND USAGEHalfLytely and Bisacodyl Tablets Bowel Prep Kit is indicated for cleansing of the colon as a preparation for colonoscopy in adults.
2 DOSAGE AND ADMINISTRATIONThe recommended HalfLytely and Bisacodyl Tablets Bowel Prep Kit oral dosage regimen for adults on the day prior to colonoscopy isas follows: Take two 5 mg bisacodyl delayed release tablets with water. Do NOT chew or crush the tablets.Add flavor pack of choice (if applicable) to the 2 liter container. No additional ingredients (other than flavor packs provided) shouldbe added to the solution.Prepare the HalfLytely solution by filling the container to the 2 liter mark with water.
Cap the container. Shake to dissolve thepowder.Wait for a bowel movement (or maximum of 6 hours) then drink the 2 liter HalfLytely solution at a rate of 8 ounces every 10minutes. Drink all of the solution.3 DOSAGE FORMS AND STRENGTHS Two pink, round, enteric coated 5 mg bisacodyl delayed release tablets, stamped 223BRA224 One 2 liter HalfLytely bottle with powder for reconstitution4 CONTRAINDICATIONSThe HalfLytely and Bisacodyl Tablets Bowel Prep Kit is contraindicated in the following conditions: Known allergies to polyethylene glycol or other components of the kit Gastrointestinal (GI) obstruction Bowel perforation Toxic colitis Toxic megacolon5 WARNINGS AND PRECAUTIONS5.
1 NeurologicThere have been reports of generalized tonic-clonic seizures in patients with use of large volume (4 liter) PEG-based colon preparationproducts in patients with no prior history of seizures.
The seizure cases were associated with severe vomiting, excessive beverageconsumption and electrolyte abnormalities (for example, hyponatremia, hypokalemia).
The neurologic abnormalities resolved withcorrection of fluid and electrolyte abnormalities. Therefore, HalfLytely and Bisacodyl Tablets Bowel Prep Kit should be used withcaution in patients using concomitant medications (such as diuretics) that increase the risk of electrolyte abnormalities or patients withknown or suspected hyponatremia. Monitor baseline and post-colonoscopy.

LABORATORY TESTS

laboratory tests (sodium, potassium, calcium, creatinine,and BUN) in these patients.
5.2 GastrointestinalUse with caution in patient with severe ulcerative colitis, ileus or gastric retention. Observe patients with impaired gag reflex andpatients prone to regurgitation or aspiration during administration of HalfLytely solution. If GI obstruction or perforation is suspected,appropriate studies should be performed to rule out these conditions before administration. There have been reports of ischemic colitisin patients with use of HalfLytely and 20 mg Bisacodyl Tablets Bowel Prep Kit. If patients develop severe abdominal pain or rectalbleeding, patients should be evaluated as soon as possible.
5.3 Renal InsufficiencyPatients with impaired water handling who experience severe vomiting should be closely monitored including measurement ofelectrolytes (sodium, potassium, calcium, BUN and creatinine).
5.4 Allergic ReactionHives and skin rashes have been reported with PEG-3350 based products which are suggestive of an allergic reaction. page 3 of 6 6 ADVERSE REACTIONS
6.1 Clinical Studies ExperienceBecause clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of adrug cannot be directly compared to rates in clinical studies of another drug and may not reflect the rates observed in practice.In a clinical study of HalfLytely and (10 mg vs. 20 mg) Bisacodyl Tablets Bowel Prep Kit multicentered, controlled clinical trials,abdominal pain/cramping, nausea, vomiting and headache were the most common adverse reactions (< 3%) after the administrationof HalfLytely and (10 mg or 20 mg) Bisacodyl Tablets Bowel Prep Kit. Less than 1% of patients exposed to HalfLytely and 10 mgBisacodyl Tablets Bowel Prep Kit reported vomiting and abdominal pain/cramping.The data in Table 1 reflects exposure in 222 patients to HalfLytely and 10 mg bisacodyl tablets vs. 223 patients exposed to HalfLytelyand 20 mg bisacodyl tablets. The HalfLytely and 10 mg Bisacodyl Tablets Bowel Prep Kit population was 20-85 years of age,46% male, 54% female, 10% African American, 85% Caucasian, 8% Hispanic requiring a colonoscopy. The demographics of thecomparator group were similar.Table
1: Adverse Reactions Observed in at Least 1% of Patients HalfLytely and 10 mgBisacodyl TabletsBowel Prep Kit (N=222) HalfLytely and 20 mgBisacodyl TabletsBowel Prep Kit (N=223) Abdominal pain/cramping 1% 2% Nausea 1% 2% Vomiting 1% 2% Headache 2% 1% Table 2 displays patient diary ratings of their symptoms associated with HalfLytely and Bisacodyl Tablets Bowel Prep Kits (10 mgbisacodyl vs. 20 mg bisacodyl tablets) in the controlled trial.Table 2: Percentage of Patients Reporting in their Diaries 223bothersome224 to 223severely distressing224 Symptoms in Controlled ClinicalHalfLytely and Bisacodyl Tablets Bowel Prep Kit Trial1 Half Lytely and 10 mgBisacodyl TabletsBowel Prep Kit (N=222) HalfLytely and 20 mgBisacodyl TabletsBowel Prep Kit (N=223) Nausea 13% 21% Abdominal cramping 7% 14% Abdominal fullness 11% 13% Vomiting 5% 8% Overall Discomfort 14% 20% 1 Patients were specifically asked about the occurrence of the following symptoms: nausea, abdominal cramping, fullness, vomiting,and overall discomfort.
6.2 Postmarketing ExperienceThe following adverse reactions have been identified during postapproval use of HalfLytely and Bisacodyl Tablets Bowel Prep Kit.Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate theirfrequency or establish a causal relationship to drug exposure.Allergic Reactions: Cases of urticaria, rhinorrhea, dermatitis and anaphylactic reactions have been reported with PEG-based productswhich may represent allergic reactions.Gastrointestinal:There are isolated reports of serious post-marketing events following the administration of PEG-based products in patients over60 years of age. These adverse reactions include upper GI bleeding from a Mallory-Weiss tear, esophageal perforation, asystole,and acute pulmonary edema after vomiting and aspirating the PEG-based solution. In addition, during administration of 4 liters ofPEG-3350 colon cleansing preparation the following serious adverse reactions were seen: two deaths in end stage renal failure patientswho developed diarrhea, vomiting and dysnatremia.Ischemic colitis has been reported with use of HalfLytely and 20 mg Bisacodyl Tablets Bowel Prep Kit for colon preparation prior tocolonoscopy. However, a causal relationship between these ischemic colitis cases and the use of HalfLytely and Bisacodyl TabletsBowel Prep Kit has not been established. page 4 of 6 Neurologic: There have been reports of generalized tonic-clonic seizures associated with use of large volume (4 liter) PEG-basedcolon preparation products in patients with no prior history of seizures. Cases of dizziness and syncope have been reported [seeWarnings and Precautions (5.1)]
.7 DRUG INTERACTIONS Oral medication administered within one hour of the start of administration of HalfLytely solution may be flushed from the GI tractand the medication may not be absorbed.Do not take the bisacodyl delayed release tablets within one hour of taking an antacid.
8 USE IN SPECIFIC POPULATIONS8.1 PregnancyPregnancy Category C. Animal reproduction studies have not been conducted. It is not known whether HalfLytely and BisacodylTablets Bowel Prep Kit can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. HalfLytelyand Bisacodyl Tablets Bowel Prep Kit should be given to a pregnant or nursing woman only if clearly needed.
8.3 Nursing MothersIt is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should beexercised when HalfLytely and Bisacodyl Tablets Bowel Prep Kit is administered to a nursing woman.
8.4 Pediatric UseSafety and effectiveness in pediatric patients has not been established.
8.5 Geriatric UseOf the 222 patients who received HalfLytely and 10 mg Bisacodyl Tablets Bowel Prep Kit in clinical trials, 73 (33%) were 65 yearsof age or older, while 18 (8%) were 75 years of age or older. No overall differences in safety or effectiveness were observed betweengeriatric patients and younger patients, and other reported clinical experience has not identified differences in responses betweengeriatric patients and younger patients but greater sensitivity of some older individuals cannot be ruled out.11 DESCRIPTIONEach HalfLytely and Bisacodyl Tablets Bowel Prep Kit [Polyethylene glycol (PEG) 3350, sodium chloride, sodium bicarbonateand potassium chloride for oral solution and bisacodyl delayed release tablets] consists of one 2 liter bottle of HalfLytely (PEG-3350,sodium chloride, sodium bicarbonate and potassium chloride for oral solution) powder for reconstitution and two 5 mg bisacodyl,delayed release tablets.Bisacodyl delayed release tablets: Each pink, round, enteric coated bisacodyl delayed release tablet (stamped 223BRA224) contains5 mg of bisacodyl, USP (C22H19NO4) with a molecular weight of 361.40.

INACTIVE INGREDIENT

Bisacodyl delayed release tablets: Each pink, round, enteric coated bisacodyl delayed release tablet (stamped “BRA”) contains 5 mg of bisacodyl, USP (C22H19NO4) with a molecular weight of 361.40. Inactive ingredients include lactose (anhydrous) NF, microcrystalline cellulose NF, croscarmellose sodium NF, magnesium stearate NF, Eudragit L 30-55, polyethylene glycol 400, talc USP, gelatin, calcium sulfate (anhydrous) NF, confectioners sugar, kaolin USP, sucrose NF, Opalux pink, beeswax, and carnauba wax. The bisacodyl delayed release tablets are administered orally prior to drinking the HalfLytely solution [see Dosage and Administration].

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DRUG: Bisacodyl
GENERIC: Bisacodyl
DOSAGE: TABLET
ADMINSTRATION: ORAL
NDC: 24236-199-30
STRENGTH:5 mg
COLOR: orange
SHAPE: ROUND
SCORE: No score
SIZE: 5 mm
IMPRINT: 30
QTY: 400

What is GlycoLax?

GlycoLax is a laxative solution that increases the amount of water in the intestinal tract to stimulate bowel movements.

GlycoLax is used as a laxative to treat occasional constipation or irregular bowel movements.

GlycoLax may also be used for purposes not listed in this medication guide.

GlycoLax side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop taking GlycoLax and call your doctor at once if you have:

• severe or bloody diarrhea;
• rectal bleeding;
• blood in your stools; or
• severe and worsening stomach pain.

Common side effects of GlycoLax may include:

• bloating, gas, upset stomach;
• dizziness; or
• increased sweating.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA .

Warnings

You should not use this medicine if you have a bowel obstruction or intestinal blockage. If you have any of these conditions, you could have dangerous or life-threatening side effects from GlycoLax.

Do not use GlycoLax more than once per day. Call your doctor if you are still constipated or irregular after using this medication for 7 days in a row.

Before taking this medicine

You should not use GlycoLax if you are allergic to polyethylene glycol, or if you have a bowel obstruction or intestinal blockage. If you have any of these conditions, you could have dangerous or life-threatening side effects from GlycoLax.

People with eating disorders (such as anorexia or bulimia) should not use this medication without the advice of a doctor.

To make sure this medicine is safe for you, tell your doctor if you have:

• nausea, vomiting, or severe stomach pain;
• ulcerative colitis;
• irritable bowel syndrome;
• kidney disease; or
• if you have had a sudden change in bowel habits that has lasted 2 weeks or longer.

FDA pregnancy category C. It is not known whether GlycoLax will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether polyethylene glycol 3350 passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

How should I take GlycoLax?

Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

To use the powder form of this medicine, measure your dose with the medicine cap on the bottle. This cap should contain dose marks on the inside of it. Pour the powder into 4 to 8 ounces of a cold or hot beverage such as water, juice, soda, coffee, or tea. Stir this mixture and drink it right away. Do not save for later use.

GlycoLax should produce a bowel movement within 1 to 3 days of using the medication. This medicine normally causes loose or even watery stools.

Do not use GlycoLax more than once per day. Call your doctor if you are still constipated or irregular after using this medication for 7 days in a row.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What should I avoid while taking GlycoLax?

Follow your doctor’s instructions about any restrictions on food, beverages, or activity.

What is GoLYTELY?

GoLYTELY is a laxative solution that stimulates bowel movements. This medication also contains minerals to replace electrolytes that are passed from the body in the stool.

GoLYTELY is used to clean the bowel before colonoscopy, a barium x-ray, or other intestinal procedures.

GoLYTELY may also be used for purposes not listed in this medication guide.

GoLYTELY side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

GoLYTELY may cause serious side effects. Call your doctor at once if you have:

• no bowel movement within 2 hours after use;
• vomiting;
• dizziness, feeling like you might pass out;
• little or no urination;
• a seizure; or
• signs of an electrolyte imbalance–increased thirst or urination, dry mouth, confusion, constipation, muscle pain or weakness, leg cramps, irregular heartbeats, tingly feeling.

You may need to drink the liquid more slowly, or stop using it for a short time if you have certain side effects. Call your doctor for instructions if you have:

• gagging, choking, severe stomach pain or bloating;
• nausea, vomiting, headache, trouble drinking liquids, little or no urinating; or
• fever, sudden or severe stomach pain, severe diarrhea, rectal bleeding or bright red bowel movements.

Common side effects of GoLYTELY may include:

• vomiting, stomach pain, indigestion, bloating;
• rectal pain or irritation;
• hunger, thirst, mild nausea;
• trouble sleeping; or
• dizziness, chills.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA .

Warnings

Do not use GoLYTELY if you have a perforated bowel, a bowel obstruction or severe constipation, or colitis or toxic megacolon. GoLYTELY can cause dangerous or life-threatening side effects in people with these conditions.

Before taking this medicine

You should not use this medicine if you are allergic to polyethylene glycol or any other electrolyte solutions (such as Pedialyte or Gatorade), or if you have:

• a perforated bowel;
• a bowel obstruction or severe constipation; or
• colitis or toxic megacolon.

GoLYTELY can cause dangerous or life-threatening side effects in people with these conditions.

People with eating disorders (such as anorexia or bulimia) should not use this medicine without the advice of a doctor.

Tell your doctor if you have ever had:

• heart problems, or a heart attack;
• an electrolyte imbalance (such as low levels of potassium or sodium in your blood);
• kidney disease;
• a seizure;
• gastroesophageal reflux disease (GERD), ulcerative colitis, or other stomach or bowel disorder;
• trouble swallowing, aspiration (accidentally inhaling food or drink);
• a genetic enzyme deficiency called glucose-6-phosphate dehydrogenase (G6PD) deficiency; or
• a drug or alcohol addiction.

Tell your doctor if you are pregnant or breast-feeding.

This medicine may contain phenylalanine. Talk to your doctor before using if you have phenylketonuria (PKU).

How should I take GoLYTELY?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Polyethylene glycol electrolyte powder must be mixed with water into a solution before using it. Do not add any flavorings such as sugar, honey, artificial sweetener, fruit juices, or other beverages.

Shake the mixture well just before you measure a dose. Drink GoLYTELY in the exact portions at the exact time intervals prescribed by your doctor.

This medicine comes with instructions about when and what to eat or drink on your first day of treatment. Each brand may have different instructions.

Do not drink GoLYTELY if it has been less than 1 hour since you last ate solid food. For best results, take the medicine 2 to 4 hours after you last ate.

The first watery stool should appear within 1 hour after you start drinking GoLYTELY. Keep taking the medicine until you have completed all doses prescribed by your doctor.

Drink plenty of clear liquids (water, broth, black coffee, tea, clear soda) before, during, and after you take this medicine. Avoid foods and beverages that contain pulp or are red or purple in color. You may also eat popsicles (not fruit bars or fudge bars) or gelatin without fruit pieces or toppings.

Do not eat or drink anything within 2 hours before your colonoscopy or other medical test.

Store the unmixed powder at room temperature away from moisture and heat.

Store the mixed solution in a refrigerator in an upright position.

Throw away any GoLYTELY you have not used within 24 to 48 hours after it was mixed (follow directions for your specific brand of this medicine).

What happens if I miss a dose?

Talk to your doctor if you cannot drink all of the solution prescribed for you. Your test or procedure may need to be rescheduled if your bowel is not completely cleansed.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What should I avoid while taking GoLYTELY?

Avoid taking other medications, vitamins, or mineral supplements within 1 hour before drinking GoLYTELY. A bowel cleansing can make it harder for your body to absorb other medicines you take by mouth.

Do not use other laxatives while using GoLYTELY unless your doctor has told you to.

What other drugs will affect GoLYTELY?

Tell your doctor about all your other medicines, especially:

• heart or blood pressure medication;
• a diuretic or “water pill”;
• medicine to treat anxiety, depression, or mental illness;
• medications to treat kidney problems or low sodium levels (hyponatremia);

What is lactulose?

Lactulose is used to treat chronic constipation.

Lactulose is sometimes used to treat or prevent certain conditions of the brain that are caused by liver failure. These conditions can lead to confusion, problems with memory or thinking, behavior changes, tremors, feeling irritable, sleep problems, loss of coordination, and loss of consciousness.

Lactulose may also be used for purposes not listed in this medication guide.

Lactulose side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using lactulose and call your doctor at once if you have severe or ongoing diarrhea.

Common side effects of lactulose may include:

• bloating, gas;
• stomach pain;
• diarrhea; or
• nausea, vomiting.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA .

Warnings

Use only as directed. Tell your doctor if you use other medicines or have other medical conditions or allergies.

Before taking this medicine

You should not use lactulose if you are on a special diet low in galactose (milk sugar).

Tell your doctor if you have ever had:

• diabetes; or
• if you need to have any type of intestinal test using a scope (such as a colonoscopy).

Tell your doctor if you are pregnant or breastfeeding.

How should I take lactulose?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Mix lactulose powder with at least 4 ounces of water, milk, or fruit juice.

Measure liquid medicine with the supplied measuring device (not a kitchen spoon).

Lactulose should produce a bowel movement within 24 to 48 hours.

If you use lactulose long-term, you may need frequent medical tests.

Tell your doctor if you have a planned colonoscopy or proctoscopy procedure.

Store tightly closed at room temperature, away from moisture and heat. Avoid freezing.

The liquid may turn darker in color, but this will not affect the medicine. Do not use the medicine if it becomes very dark or gets thicker or thinner in texture.

Lactulose dosing information

Usual Adult Dose for Constipation — Chronic:

15 mL orally once a day.

Usual Adult Dose for Constipation — Acute:

Initial dose: 15 mL orally once a day. Therapy should be continued until normal bowel function resumes.

Usual Adult Dose for Hepatic Encephalopathy:

Initial dose: 30 mL orally 3 times a day or
300 mL in 700 mL water or normal saline as an enema retained for 30 to 60 minutes every 4 to 6 hours.
Maintenance dose: 30 to 45 mL orally 3 times a day.

Usual Pediatric Dose for Hepatic Encephalopathy:

Infants: 1.7 to 6.7 g/day (2.5 to 10 mL) orally daily divided in 3 to 4 doses. Adjust dosage to produce 2 to 3 soft stools per day.

Children: 26.7 to 60 g/day (40 to 90 mL) orally daily divided in 3 to 4 doses. Adjust dosage to produce 2 to 3 soft stools per day.

Usual Pediatric Dose for Constipation — Chronic:

Children: 0.7 to 2 g/kg/day (1 to 3 mL/kg/day) orally in divided doses daily; generally recommended not to exceed the adult maximum of 40 g/day (60 mL/day).

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

Overdose may cause nausea, vomiting, diarrhea, and stomach cramps, or symptoms of low blood potassium or low blood sodium (confusion, weakness, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling, muscle weakness or limp feeling).

What should I avoid while taking lactulose?

Ask your doctor before taking any other laxative or an antacid, and take only the type your doctor recommends.

What is magnesium sulfate?

Magnesium is a naturally occurring mineral that is important for many systems in the body especially the muscles and nerves. Magnesium sulfate also increases water in the intestines.

Magnesium sulfate is used as a laxative to relieve occasional constipation.

Magnesium sulfate (Epsom salt) can also be added to a bath for use as a soaking solution to help relieve minor sprains and bruises. Not all external uses for magnesium sulfate have been approved by the FDA. Epsom salt should not be used in place of medication prescribed for you by your doctor.

Magnesium sulfate may also be used for purposes not listed in this medication guide.

Magnesium sulfate side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Common side effects may include diarrhea or upset stomach.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA .

Warnings

Never use a higher dose of magnesium sulfate than recommended on the package label, or as your doctor has directed. Using too much magnesium sulfate can cause serious, life-threatening side effects.

Do not use magnesium sulfate as a laxative without medical advice if you have: severe stomach pain, nausea, vomiting, a perforated bowel, a bowel obstruction, severe constipation, colitis, toxic megacolon, or a sudden change in bowel habits that has lasted 2 weeks or longer.

If you have rectal bleeding or if you do not have a bowel movement after using magnesium sulfate as a laxative, stop using the medication and call your doctor at once. These may be signs of a more serious condition.

Before taking this medicine

Do not use magnesium sulfate as a laxative without medical advice if you have:

• severe stomach pain;
• nausea or vomiting;
• a perforated bowel;
• a bowel obstruction or severe constipation;
• colitis or toxic megacolon; or
• a sudden change in bowel habits lasting 2 weeks or longer.

Ask a doctor or pharmacist if it is safe for you to take this medicine if you have:

• diabetes;
• kidney disease;
• an eating disorder (anorexia or bulimia);
• if you have already been using a laxative for longer than 1 week; or
• if you on a low-magnesium diet.

It is not known whether magnesium sulfate will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether magnesium sulfate passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

How should I take magnesium sulfate?

Use exactly as directed on the label, or as prescribed by your doctor.

Never use a higher dose of magnesium sulfate than recommended on the package label, or as your doctor has directed. Using too much magnesium sulfate can cause serious, life-threatening side effects.

Magnesium sulfate may be used orally (by mouth) or as a soak. Follow your doctor’s instructions or the directions on the package.

To take magnesium sulfate orally, dissolve one dose in 8 ounces of water. Stir this mixture and drink all of it right away. You may add a small amount of lemon juice to improve the taste of this mixture.

Magnesium sulfate taken orally should produce a bowel movement within 30 minutes to 6 hours.

Drink plenty of liquids while you are taking magnesium sulfate.

If you have rectal bleeding or if you do not have a bowel movement after using magnesium sulfate as a laxative, stop using the medication and call your doctor at once. These may be signs of a more serious condition.

To use magnesium sulfate as an epsom salt soak, dissolve in a large amount of water in a large bowl, a bucket, a foot tub, or a bath tub. Follow the directions on the product label about how much epsom salt to use per gallon of water.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Since magnesium sulfate is used on an as needed basis, you are not likely to miss a dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line . An overdose of magnesium sulfate can be fatal

Overdose symptoms may include nausea, vomiting, flushing (warmth, redness, or tingly feeling), feeling very hot, slow heart rate, extreme drowsiness, or fainting.

What should I avoid while taking magnesium sulfate?

Magnesium sulfate taken orally can make it harder for your body to absorb other medications you take by mouth, especially antibiotics. Avoid taking other medicines within 2 hours before or after you take magnesium sulfate as a laxative.

What other drugs will affect magnesium sulfate?

Other drugs may interact with magnesium sulfate, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

What is MiraLAX?

MiraLAX is a laxative solution that increases the amount of water in the intestinal tract to stimulate bowel movements.

MiraLAX is used as a laxative to treat occasional constipation or irregular bowel movements.

MiraLAX may also be used for purposes not listed in this medication guide.

Important information about MiraLAX

You should not use MiraLAX if you have a bowel obstruction or intestinal blockage. If you have any of these conditions, you could have dangerous or life-threatening side effects from MiraLAX.

People with eating disorders (such as anorexia or bulimia) should not use MiraLAX without the advice of a doctor.

Before taking MiraLAX, tell your doctor if you are allergic to any drugs, or if you have ulcerative colitis, irritable bowel syndrome, kidney disease, nausea or vomiting with severe stomach pain, or if you have had a sudden change in bowel habits that has lasted 2 weeks or longer.

MiraLAX should produce a bowel movement within 1 to 3 days of using the medication. Polyethylene glycol 3350 normally causes loose or even watery stools.

Do not use MiraLAX more than once per day. Call your doctor if you are still constipated or irregular after using this medication for 7 days in a row.

Before taking this medicine

You should not use MiraLAX if you are allergic to polyethylene glycol, or if you have a bowel obstruction or intestinal blockage. If you have any of these conditions, you could have dangerous or life-threatening side effects from polyethylene glycol 3350.

People with eating disorders (such as anorexia or bulimia) should not use this medication without the advice of a doctor.

To make sure this medicine is safe for you, tell your doctor if you have:

• nausea, vomiting, or severe stomach pain;
• ulcerative colitis;
• irritable bowel syndrome;
• kidney disease; or
• if you have had a sudden change in bowel habits that has lasted 2 weeks or longer.

FDA pregnancy category C. It is not known whether MiraLAX will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether polyethylene glycol 3350 passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

How should I take MiraLAX?

Use MiraLAX exactly as directed on the label, or as it has been prescribed by your doctor. Do not use this medicine in larger or smaller amounts or for longer than recommended.

To use MiraLAX powder, measure your dose with the medicine cap on the bottle. This cap should contain dose marks on the inside of it. Pour the powder into 4 to 8 ounces of a cold or hot beverage such as water, juice, soda, coffee, or tea. Stir this mixture and drink it right away. Do not save for later use.

MiraLAX should produce a bowel movement within 1 to 3 days of using the medication. Polyethylene glycol 3350 normally causes loose or even watery stools.

Do not use MiraLAX more than once per day. Call your doctor if you are still constipated or irregular after using this medication for 7 days in a row.

Store at room temperature away from moisture and heat.

Dosing information

Usual Adult Dose of MiraLAX for Constipation:

17 g (diluted in 8 fluid ounces water, juice, soda or coffee) orally once a day

Usual Pediatric Dose for Bowel Preparation:

Occasional constipation:
Children greater than 6 months of age: 0.5 to 1.5 g/kg daily (initial dose 0.5 g/kg; titrate to effect)
Maximum dose: 17 g/day

Fecal impaction:
Children greater than 3 years of age: 1 to 1.5 g/kg daily for 3 days
Maximum dose: 100 g daily

Bowel preparation:
Children greater than 2 years of age: 1.5 g/kg/day
Maximum dose: 100 g daily

Usual Pediatric Dose of MiraLAX for Constipation — Acute:

Occasional constipation:
Children greater than 6 months of age: 0.5 to 1.5 g/kg daily (initial dose 0.5 g/kg; titrate to effect)
Maximum dose: 17 g/day

Fecal impaction:
Children greater than 3 years of age: 1 to 1.5 g/kg daily for 3 days
Maximum dose: 100 g daily

Bowel preparation:
Children greater than 2 years of age: 1.5 g/kg/day
Maximum dose: 100 g daily

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What should I avoid?

Follow your doctor’s instructions about any restrictions on food, beverages, or activity.

MiraLAX side effects

Get emergency medical help if you have any signs of an allergic reaction to MiraLAX: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop taking this medicine and call your doctor at once if you have:

• severe or bloody diarrhea;
• rectal bleeding;
• blood in your stools; or
• severe and worsening stomach pain.

Common MiraLAX side effects may include:

• bloating, gas, upset stomach;
• dizziness; or
• increased sweating.