What is codeine?

Codeine is an opioid pain reliever which is used to treat mild to moderately severe pain and to help reduce coughing. Codeine is available as a single ingredient tablet and also available in multi ingredients products combined with other pain relieving medicines or cold and flu medicines.

Warnings

You should not use codeine if you have severe breathing problems, a blockage in your stomach or intestines, or frequent asthma attacks or hyperventilation.

Codeine can slow or stop your breathing, cause profound sedation, and may be habit-forming. MISUSE OF THIS MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a child or other person using the medicine without a prescription.

Codeine is not for use in anyone under 18 years old.

Taking codeine during pregnancy may cause life-threatening withdrawal symptoms in the newborn.

Fatal side effects can occur if you use codeine with alcohol, or with other drugs that cause drowsiness, sedation or slow your breathing.

Before taking this medicine

You should not use this medicine if you are allergic to it, or if you have:

• severe asthma or breathing problems;
• a blockage in your stomach or intestines; or
• frequent asthma attacks or hyperventilation.

In some people, codeine breaks down rapidly in the liver and reaches higher than normal levels in the body. This can cause dangerously slow breathing and may cause death, especially in a child.

Do not give codeine to anyone younger than 18 years old.

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

• liver disease;
• breathing problems, sleep apnea;
• asthma, COPD, sleep apnea, or other breathing disorders;
• abnormal curvature of the spine that affects breathing;
• kidney disease;
• a head injury or brain tumor;
• low blood pressure;
• blockage in your digestive tract (stomach or intestines);
• a gallbladder or pancreas disorder;
• underactive thyroid;
• Addison’s disease or other adrenal gland disorder;
• enlarged prostate, urination problems; or
• mental illness, drug or alcohol addiction.

Some medicines can interact with codeine and cause a serious condition called serotonin syndrome. Be sure your doctor knows if you also take stimulant medicine, herbal products, or medicine for depression, mental illness, Parkinson’s disease, migraine headaches, serious infections, or prevention of nausea and vomiting. Ask your doctor before making any changes in how or when you take your medications.

If you use this medicine while you are pregnant, your baby could become dependent on the drug. This can cause life-threatening withdrawal symptoms in the baby after it is born. Babies born dependent on habit-forming medicine may need medical treatment for several weeks. Tell your doctor if you are pregnant or plan to become pregnant.

Do not breast-feed while taking codeine. This medicine can pass into breast milk and cause drowsiness, breathing problems, or death in a nursing baby.

How should I take codeine?

Take codeine exactly as prescribed by your doctor. Follow all directions on your prescription label. Codeine can slow or stop your breathing. Never use this medicine in larger amounts, or for longer than prescribed. Tell your doctor if the medicine seems to stop working as well in relieving your pain.

Codeine may be habit-forming, even at regular doses. Never share this medicine with another person, especially someone with a history of drug abuse or addiction. MISUSE OF NARCOTIC MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a child or other person using the medicine without a prescription. Selling or giving away codeine is against the law.

Take this medicine with food or milk if it upsets your stomach.

Drink 6 to 8 full glasses of water daily to help prevent constipation while you are taking this medicine. Do not use a stool softener (laxative) without first asking your doctor.

Do not stop using codeine suddenly after long-term use, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using this medicine.

Store at room temperature away from moisture and heat. Keep track of your medicine. Codeine is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

Do not keep leftover opioid medication. Just one dose can cause death in someone using this medicine accidentally or improperly. Ask your pharmacist where to locate a drug take-back disposal program. If there is no take-back program, mix the leftover medicine with cat litter or coffee grounds in a sealed plastic bag throw the bag in the trash.

What happens if I miss a dose?

Since this medicine is used for pain, you are not likely to miss a dose. Skip any 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 . A codeine overdose can be fatal, especially in a child or other person using the medicine without a prescription. Overdose can cause severe muscle weakness, cold and clammy skin, pinpoint pupils, very slow breathing, extreme drowsiness, or coma.

What to avoid

Do not drink alcohol. Dangerous side effects or death could occur.

Codeine may impair your thinking or reactions. Avoid driving or operating machinery until you know how this medicine will affect you. Dizziness or severe drowsiness can cause falls or other accidents.

Codeine side effects

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

Like other narcotic medicines, codeine can slow your breathing. Death may occur if breathing becomes too weak.

A person caring for you should seek emergency medical attention if you have slow breathing with long pauses, blue colored lips, or if you are hard to wake up.

Call your doctor at once if you have:

• noisy breathing, sighing, shallow breathing, breathing that stops during sleep;
• a slow heart rate or weak pulse;
• a light-headed feeling, like you might pass out;
• confusion, agitation, hallucinations, unusual thoughts or behavior;
• feelings of extreme happiness or sadness;
• seizure (convulsions);
• problems with urination; or
• low cortisol levels–nausea, vomiting, loss of appetite, dizziness, worsening tiredness or weakness.

Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.

Serious side effects may be more likely in older adults and those who are overweight, malnourished, or debilitated.

Long-term use of opioid medication may affect fertility (ability to have children) in men or women. It is not known whether opioid effects on fertility are permanent.

Common codeine side effects include:

• feeling dizzy or drowsy;
• nausea, vomiting, stomach pain;
• constipation;
• sweating; or
• mild itching or rash.

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

Dosing information

Usual Adult Dose for Pain:

Initial dose: 15 to 60 mg orally up to every 4 hours as needed
Maximum dose: 360 mg in 24 hours

Comments:
-Initial doses should be individualized taking into account severity of pain, response, prior analgesic treatment experience, and risk factors for addiction, abuse, and misuse.
-Doses higher than 60 mg have not been shown to improve pain relief and are associated with an increased incidence of adverse effects.
-Because of the risks of addiction, abuse and misuse, the lowest effective dose for the shortest duration consistent with individual patient treatment goals should be used.
-Monitor patients closely for respiratory depression within the first 24 to 72 hours of initiating therapy and following any increase in dose.

Use: For the management of mild to moderate pain where treatment with an opioid is appropriate and from which alternative treatments are inadequate.

What other drugs will affect codeine?

You may have breathing problems or withdrawal symptoms if you start or stop taking certain other medicines. Tell your doctor if you also use an antibiotic, antifungal medication, heart or blood pressure medication, seizure medication, or medicine to treat HIV or hepatitis C.

Opioid medication can interact with many other drugs and cause dangerous side effects or death. Be sure your doctor knows if you also use:

• cold or allergy medicines, bronchodilator asthma/COPD medication, or a diuretic (“water pill”);
• medicines for motion sickness, irritable bowel syndrome, or overactive bladder;
• other narcotic medications – opioid pain medicine or prescription cough medicine;
• a sedative like Valium – diazepam, alprazolam, lorazepam, Xanax, Klonopin, Versed, and others;
• drugs that make you sleepy or slow your breathing – a sleeping pill, muscle relaxer, medicine to treat mood disorders or mental illness; or
• drugs that affect serotonin levels in your body– a stimulant, or medicine for depression, Parkinson’s disease, migraine headaches, serious infections, or nausea and vomiting.

Bromfed DM (Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide Oral Syrup) is a pink, sugar free syrup with a melon flavor.

Each 5 mL (1 teaspoonful) contains:

Brompheniramine Maleate, USP . . . . . . . . 2 mg

Pseudoephedrine Hydrochloride, USP . . . . . 30 mg

Dextromethorphan Hydrobromide, USP . . . 10 mg

Inactive Ingredients:citric acid anhydrous, FD&C Red #40, glycerin, melon flavoring, methylparaben, propylene glycol, purified water, sodium benzoate, sodium citrate dihydrate, and sucralose.

C 16H 19BrN 2•C 4H 4O 4M.W. 435.31
Brompheniramine Maleate, USP
(±)-2- p-Bromo-α-2-(dimethylamino)ethylbenzylpyridine maleate (1:1)

C 10H 15NO•HCl M.W. 201.69
Pseudoephedrine Hydrochloride, USP
(+)-Pseudoephedrine hydrochloride

C 18H 25NO•HBr•H 2O M.W. 370.32
Dextromethorphan Hydrobromide, USP
3-Methoxy-17-methyl-9α, 13α, 14α -morphinan hydrobromide monohydrate

Antihistamine/ Nasal Decongestant/ Antitussive syrup for oral administration.

Bromfed DM – Clinical Pharmacology

Brompheniramine maleate is a histamine antagonist, specifically an H1-receptor-blocking agent belonging to the alkylamine class of antihistamines. Antihistamines appear to compete with histamine for receptor sites on effector cells. Brompheniramine also has anticholinergic (drying) and sedative effects. Among the antihistaminic effects, it antagonizes the allergic response (vasodilation, increased vascular permeability, increased mucus secretion) of nasal tissue. Brompheniramine is well absorbed from the gastrointestinal tract, with peak plasma concentration after single, oral dose of 4 mg reached in 5 hours; urinary excretion is the major route of elimination, mostly as products of biodegradation; the liver is assumed to be the main site of metabolic transformation.

Pseudoephedrine acts on sympathetic nerve endings and also on smooth muscle, making it useful as a nasal decongestant. The nasal decongestant effect is mediated by the action of pseudoephedrine on α-sympathetic receptors, producing vasoconstriction of the dilated nasal arterioles. Following oral administration, effects are noted within 30 minutes with peak activity occurring at approximately one hour.

Dextromethorphan acts centrally to elevate the threshold for coughing. It has no analgesic or addictive properties. The onset of antitussive action occurs in 15 to 30 minutes after administration and is of long duration.

Indications and Usage for Bromfed DM

Bromfed DM (Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide Oral Syrup) is indicated for relief of coughs and upper respiratory symptoms, including nasal congestion, associated with allergy or the common cold.

Contraindications

Hypersensitivity to any of the ingredients. Do not use in the newborn, in premature infants, in nursing mothers, or in patients with severe hypertension or severe coronary artery disease. Do not use dextromethorphan in patients receiving monoamine oxidase inhibitors (MAOIs) .

Antihistamines should not be used to treat lower respiratory tract conditions including asthma.

Warnings

Especially in infants and small children, antihistamines in overdosage may cause hallucinations, convulsions, and death.

Antihistamines may diminish mental alertness. In the young child, they may produce excitation.

Precautions

General

Because of its antihistamine component, Bromfed DM Syrup (Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide Oral Syrup) should be used with caution in patients with a history of bronchial asthma, narrow angle glaucoma, gastrointestinal obstruction, or urinary bladder neck obstruction. Because of its sympathomimetic component, Bromfed DM Syrup should be used with caution in patients with diabetes, hypertension, heart disease, or thyroid disease.

Information for Patients

Patients should be warned about engaging in activities requiring mental alertness, such as driving a car or operating dangerous machinery.

Drug Interactions

Monoamine oxidase inhibitors (MAOIs)

Hyperpyrexia, hypotension, and death have been reported coincident with the coadministration of MAOIs and products containing dextromethorphan. In addition, MAOIs prolong and intensify the anticholinergic (drying) effects of antihistamines and may enhance the effect of pseudoephedrine. Concomitant administration of Bromfed DM Syrup and MAOIs should be avoided.

Central nervous system (CNS) depressants

Antihistamines have additive effects with alcohol and other CNS depressants (hypnotics, sedatives, tranquilizers, antianxiety agents, etc.).

Antihypertensive drugs

Sympathomimetic may reduce the effects of antihypertensive drugs.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Animal studies of Bromfed DM Syrup to assess the carcinogenic and mutagenic potential or the effect on fertility have not been performed.

Pregnancy

Teratogenic Effects

Animal reproduction studies have not been conducted with Bromfed DM Syrup. It is also not known whether Bromfed DM Syrup can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. It should be given to a pregnant woman only if clearly needed.

Reproduction studies of brompheniramine maleate (a component of Bromfed DM Syrup) in rats and mice at doses up to 16 times the maximum human doses have revealed no evidence of impaired fertility or harm to the fetus.

Nursing Mothers

Because of the higher risk of intolerance of antihistamines in small infants generally, and in newborns and prematures in particular, Bromfed DM Syrup is contraindicated in nursing mothers.

Pediatric Use

Safety and effectiveness in pediatric patients below the age of 6 months have not been established

Geriatric Use

Clinical studies of Bromfed DM Syrup (Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide Oral Syrup) did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. However, antihistamines are more likely to cause dizziness, sedation, and hypotension in elderly patients. The elderly are also more likely to experience adverse reactions to sympathomimetics. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Adverse Reactions/Side Effects

The most frequent adverse reactions to Bromfed DM Syrup (Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide Oral Syrup) are: sedation; dryness of mouth, nose and throat; thickening of bronchial secretions; dizziness. Other adverse reactions may include:

Dermatologic:Urticaria, drug rash, photosensitivity, pruritus.

Cardiovascular System:Hypotension, hypertension, cardiac arrhythmias, palpitation.

CNS:Disturbed coordination, tremor, irritability, insomnia, visual disturbances, weakness, nervousness, convulsions, headache, euphoria, and dysphoria.

G.U. System:Urinary frequency, difficult urination.

G.I. System:Epigastric discomfort, anorexia, nausea, vomiting, diarrhea, constipation.

Respiratory System:Tightness of chest and wheezing, shortness of breath.

Hematologic System:Hemolytic anemia, thrombocytopenia, agranulocytosis.

Overdosage

Signs and Symptoms:

Central nervous system effects from overdosage of brompheniramine may vary from depression to stimulation, especially in children. Anticholinergic effects may be noted. Toxic doses of pseudoephedrine may result in CNS stimulation, tachycardia, hypertension, and cardiac arrhythmias; signs of CNS depression may occasionally be seen. Dextromethorphan in toxic doses will cause drowsiness, ataxia, nystagmus, opisthotonos, and convulsive seizures.

Toxic Doses:

Data suggest that individuals may respond in an unexpected manner to apparently small amounts of a particular drug. A 2½-year-old child survived the ingestion of 21 mg/kg of dextromethorphan exhibiting only ataxia, drowsiness, and fever, but seizures have been reported in 2 children following the ingestion of 13–17 mg/kg. Another 2½-year-old child survived a dose of 300–900 mg of brompheniramine. The toxic dose of pseudoephedrine should be less than that of ephedrine, which is estimated to be 50 mg/kg.

Treatment:

Induce emesis if patient is alert and is seen prior to 6 hours following ingestion. Precautions against aspiration must be taken, especially in infants and small children. Gastric lavage may be carried out, although in some instances tracheostomy may be necessary prior to lavage. Naloxone hydrochloride 0.005 mg/kg intravenously may be of value in reversing the CNS depression that may occur from an overdose of dextromethorphan. CNS stimulants may counter CNS depression. Should CNS hyperactivity or convulsive seizures occur, intravenous short-acting barbiturates may be indicated. Hypertensive responses and/or tachycardia should be treated appropriately. Oxygen, intravenous fluids, and other supportive measures should be employed as indicated.

Bromfed DM Dosage and Administration

Adults and pediatric patients 12 years of age and over:10 mL (2 teaspoonfuls) every 4 hours.

Children 6 to under 12 years of age:5 mL (1 teaspoonful) every 4 hours.

Children 2 to under 6 years of age:2.5 mL (½ teaspoonful) every 4 hours.

Infants 6 months to under 2 years of age:Dosage to be established by a physician.

Do not exceed 6 doses during a 24-hour period.

How is Bromfed DM supplied

Bromfed DM Syrup (Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide Oral Syrup) is a pink, sugar free syrup with a melon flavor. Each 5 mL (1 teaspoonful) contains: brompheniramine maleate 2 mg, pseudoephedrine hydrochloride 30 mg and dextromethorphan hydrobromide 10 mg, available in the following sizes:

4 fl oz (118 mL) NDC 69437-605-04
16 fl oz (473 mL) NDC 69437-605-16

Storage and Handling

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

KEEP TIGHTLY CLOSED

Dispense in a tight, light-resistant container as defined in the USP.

Rx Only

Distributed by:

Alpharetta, GA 30004

1-800-844-302-5227

500544-01

PRINCIPAL DISPLAY PANEL

NDC 69437-605-04

Bromfed DM 4 fl oz (118 mL)

PRINCIPAL DISPLAY PANEL

NDC 69437-605-16

Bromfed DM 16 fl oz (473 mL)

Benzonatate is a non-narcotic cough medicine.

Benzonatate works by numbing the throat and lungs, making the cough reflex less active.

Benzonatate is used to relieve coughing.

Warnings

You should not use this medication if you are allergic to benzonatate or topical numbing medicines such as tetracaine or procaine (found in some insect bite and sunburn creams).

Never suck or chew on a benzonatate capsule. Swallow the pill whole. Sucking or chewing the capsule may cause your mouth and throat to feel numb or cause other serious side effects.

Serious side effects of benzonatate include choking feeling, chest pain or numbness, feeling like you might pass out, confusion, or hallucinations. Some of these side effects may result from chewing or sucking on a capsule.

Do not give this medication to a child younger than 10 years old without medical advice. An overdose of benzonatate can be fatal to a child.

Before taking this medicine

You should not use this medicine if you are allergic to benzonatate or topical numbing medicines such as tetracaine or procaine (found in some insect bite and sunburn creams).

Tell your doctor if you are pregnant or breastfeeding.

Benzonatate is not approved for use by anyone younger than 10 years old. An overdose can be fatal, especially to a young child who has accidentally swallowed the medicine.

How should I take benzonatate?

Take benzonatate exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

Always ask a doctor before giving a cough medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children.

Take each dose with a full glass of water.

Never suck or chew on a benzonatate capsule. Swallow the pill whole. Sucking or chewing the capsule may cause serious side effects.

Store at room temperature away from moisture, heat, and light.

What happens if I miss a dose?

Skip the missed dose and use your next dose at the regular time. Do not use two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line . An overdose of benzonatate can be fatal, especially to a child. Accidental death has occurred in children under 10 years old.

Overdose symptoms may include tremors, feeling restless, seizure (convulsions), slow heart rate, weak pulse, fainting, and slow breathing (breathing may stop).

What to avoid

Avoid eating or drinking anything while you feel numbness or tingling in your mouth or throat.

Benzonatate side effects

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

Call your doctor at once if you have:

• severe drowsiness or dizziness;
• confusion, hallucinations.
• ongoing numbness or tingling in your mouth, throat, or face;
• numbness in your chest;
• a choking feeling;
• chills; or
• burning in your eyes.

Some of these side effects may result from chewing or sucking on a benzonatate capsule.

Common benzonatate side effects may include:

• headache, dizziness;
• nausea, upset stomach;
• constipation;
• itching, rash; or
• stuffy nose.

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

Dosing information

Usual Adult Dose for Cough:

100 mg to 200 mg orally three times a day as needed for cough

Comments: This drug should be swallowed whole.

Use: Symptomatic relief of cough

Usual Pediatric Dose for Cough:

Children older than 10 years:
100 mg to 200 mg orally three times a day as needed for cough