Claritin is an antihistamine that reduces the effects of natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.

Claritin is used to treat sneezing, runny nose, watery eyes, hives, skin rash, hay fever, itching, and other cold or allergy symptoms.

Claritin is also used to treat skin hives and itching in people with chronic skin reactions

Warnings

You should not take Claritin if you are allergic to loratadine or to desloratadine (Clarinex).

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Some chewable dosage forms of Claritin may contain phenylalanine. Talk to your doctor before using these forms of loratadine if you have phenylketonuria (PKU).

Ask a doctor or pharmacist before taking Claritin if you have liver or kidney disease.

Before taking this medicine

Ask a doctor or pharmacist if Claritin is safe to use if you have ever had:

• kidney disease; or
• liver disease.

The chewable Claritin tablet may contain phenylalanine and could be harmful if you have phenylketonuria (PKU).

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

Do not give this medicine to a child younger than 2 years old without medical advice.

How should I take Claritin?

Use Claritin 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. Cold or allergy medicine is usually taken only for a short time until your symptoms clear up.

Do not give Claritin to a child younger than 2 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children.

Claritin is usually taken once per day. Follow your doctor’s instructions.

Do not crush, chew, or break the regular tablet. Swallow the tablet whole.

A child’s dose is based on age and some forms of loratadine are not for use in children younger than 6 years old. Carefully follow the dosing instructions provided with this medicine.

Measure liquid medicine with the dosing syringe provided, or with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one.

The Claritin chewable tablet must be chewed before you swallow it.

To take the orally disintegrating tablet (Claritin RediTab):

• Keep the tablet in its blister pack until you are ready to take it. Open the package and peel back the foil. Do not push a tablet through the foil or you may damage the tablet.
• Use dry hands to remove the tablet and place it in your mouth.
• Do not swallow the tablet whole. Allow it to dissolve in your mouth without chewing. If desired, you may drink liquid to help swallow the dissolved tablet.

Call your doctor if your symptoms do not improve, or if they get worse.

Store at room temperature away from moisture and heat.

Claritin side effects

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

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

• fast or uneven heart rate;
• severe headache; or
• a light-headed feeling, like you might pass out;

Common Claritin side effects may include:

• headache;
• feeling tired or drowsy;
• stomach pain, vomiting;
• dry mouth; or
• feeling nervous or hyperactive.

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 Allergic Rhinitis:

10 mg orally once a day
-Maximum dose: 10 mg/day

Use: Temporary relief of symptoms associated with hay fever or other upper respiratory allergies (e.g., runny nose, itchy, watery eyes, sneezing, itching of the nose/throat)

Usual Adult Dose for Urticaria:

10 mg orally once a day
-Maximum dose: 10 mg/day

Use: Temporary relief of symptoms associated with hay fever or other upper respiratory allergies (e.g., runny nose, itchy, watery eyes, sneezing, itching of the nose/throat)

Usual Pediatric Dose for Allergic Rhinitis:

2 to 5 years: 5 mg orally once a day
-Maximum dose: 5 mg/day

6 years and older: 10 mg orally once a day
-Maximum dose: 10 mg/day

Use: Temporary relief of symptoms associated with hay fever or other upper respiratory allergies (e.g., runny nose, itchy, watery eyes, sneezing, itching of the nose/throat)

Usual Pediatric Dose for Urticaria:

2 to 5 years: 5 mg orally once a day
-Maximum dose: 5 mg/day

6 years and older: 10 mg orally once a day
-Maximum dose: 10 mg/day

Use: Temporary relief of symptoms associated with hay fever or other upper respiratory allergies (e.g., runny nose, itchy, watery eyes, sneezing, itching of the nose/throat)

What other drugs will affect Claritin?

Other drugs may interact with loratadine, 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 happens if I miss a dose?

Claritin is used when needed. Do not use Claritin more than once in a 24-hour period. Do not use two doses at one time.

What happens if I overdose?

Overdose symptoms may include headache, drowsiness, and fast or pounding heartbeat.

Seek emergency medical attention or call the Poison Help line .

What should I avoid while taking Claritin?

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

Cetirizine is a second generation antihistamine that reduces the natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.

Cetirizine is used to treat cold or allergy symptoms such as sneezing, itching, watery eyes, or runny nose.

Cetirizine is also used to treat an allergic reaction, itching and swelling caused by chronic urticaria (hives) and minimizes or eliminates the symptoms of perennial allergic rhinitis, seasonal allergic rhinitis, chronic idiopathic urticaria, allergic asthma, physical urticaria, and atopic dermatitis.

Warnings

Cetirizine can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Avoid drinking alcohol. It can increase some of the side effects of cetirizine.

Tell your doctor if you regularly use other medicines that make you sleepy (such as other cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by cetirizine.

Call your doctor if your symptoms do not improve, if they get worse, or if you also have a fever.

Rarely, some people have reported severe itching when stopping cetirizine after daily, long-term use of at least a few months or several years. If you experience widespread, severe itching on stopping this medication, contact your healthcare provider.

Before taking this medicine

You should not use this medication if you are allergic to or had an adverse reaction to cetirizine.

Before taking cetirizine, tell your doctor about all of your medical conditions or if you have ever had kidney or liver disease.

Cetirizine is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Cetirizine can pass into breast milk and may harm a nursing baby. Do not use cetirizine without telling your doctor if you are breast-feeding a baby.

Cetirizine is indicated for chronic idiopathic urticaria in adults and children 6 months of age and older.

Older adults may need to take a lower than normal dose. Follow your doctor’s instructions.

How should I take cetirizine?

Take cetirizine exactly as directed on the label, or as prescribed by your doctor. Do not use it in larger amounts or for longer than recommended.

You may take cetirizine with or without food.

The chewable tablet must be chewed before you swallow it.

Oral doses: measure liquid medicine (oral solution) with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

Call your doctor if your symptoms do not improve, if they get worse, or if you also have a fever. Store cetirizine at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to take the medicine and skip the missed dose. Do not take extra medicine or add extra doses to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include feeling restless or nervous, and then feeling drowsy.

What should I avoid?

Tell your doctor if you regularly use other medicines that make you sleepy (such as other cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by cetirizine.

Cetirizine can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Avoid drinking alcohol. It can increase some of the side effects of cetirizine.

Cetirizine acute and common side effects

Get emergency medical help if you have any serious adverse effects or any of these signs of an allergic reaction: chronic idiopathic urticaria (hives); difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using cetirizine and call your doctor at once if you have any of these serious side effects:

• fast, pounding, or uneven heartbeat;
• weakness, tremors (uncontrolled shaking), or sleep problems (insomnia);
• severe restless feeling, hyperactivity;
• confusion;
• problems with vision; or
• urinating less than usual or not at all.

Less serious cetirizine side effects may include:

• dizziness, drowsiness;
• tired feeling;
• dry mouth;
• sore throat, cough;
• nausea, constipation; or
• headache.

Chlorpheniramine is an antihistamine that reduces the effects of natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.

Chlorpheniramine is used to treat runny nose, sneezing, itching, and watery eyes caused by allergies, the common cold, or the flu.

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

Chlorpheniramine 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.

Chlorpheniramine may cause serious side effects. Stop using chlorpheniramine and call your doctor at once if you have:

• fast or uneven heart rate;
• mood changes;
• tremor, seizure (convulsions);
• easy bruising or bleeding, unusual weakness;
• feeling short of breath; or
• little or no urinating.

Common side effects of chlorpheniramine may include:

• dizziness, drowsiness;
• dry mouth, nose, or throat;
• constipation;
• blurred vision; or
• feeling nervous or restless.

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

Warnings

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

You should not use chlorpheniramine if you have narrow-angle glaucoma, a blockage in your stomach or intestines, an enlarged prostate, if you are unable to urinate, or if you are having an asthma attack.

Before taking this medicine

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

• narrow-angle glaucoma;
• a blockage in your stomach or intestines;
• an enlarged prostate;
• if you are unable to urinate; or
• if you are having an asthma attack.

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

• a blockage in your digestive tract (stomach or intestines), a colostomy or ileostomy;
• liver or kidney disease;
• asthma or COPD, cough with mucus, or cough caused by smoking, emphysema, or chronic bronchitis;
• high blood pressure, heart disease, coronary artery disease, or recent heart attack;
• epilepsy or other seizure disorder;
• urination problems;
• pheochromocytoma (an adrenal gland tumor); or
• overactive thyroid.

FDA pregnancy category B. Chlorpheniramine is not expected to harm an unborn baby. Do not use this medicine without your doctor’s advice if you are pregnant.

Chlorpheniramine may pass into breast milk and may harm a nursing baby. Antihistamines may also slow breast milk production. Do not use this medicine without your doctor’s advice if you are breast-feeding a baby.

Artificially sweetened cold medicine may contain phenylalanine. If you have phenylketonuria (PKU), check the medication label to see if the product contains phenylalanine.

How should I take chlorpheniramine?

Use 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. chlorpheniramine is usually taken only for a short time until your symptoms clear up.

Do not take for longer than 7 days in a row. Talk with your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever with a headache or skin rash.

Do not crush, chew, or break an extended-release tablet. Swallow it whole. Breaking the pill may cause too much of the drug to be released at one time.

Measure liquid medicine with a special dose-measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

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

If you need surgery or medical tests, tell the surgeon or doctor ahead of time if you have taken this medicine within the past few days.

Store at room temperature away from moisture and heat. Do not allow the liquid form of this medicine to freeze.

What happens if I miss a dose?

Since this medicine is taken when needed, you may not be on a dosing schedule. If you are taking the medication regularly, 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 .

Overdose symptoms may include severe forms of some of the side effects listed in this medication guide.

What should I avoid while taking chlorpheniramine?

chlorpheniramine may cause blurred vision or impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert and able to see clearly.

Drinking alcohol can increase certain side effects of chlorpheniramine.

Ask a doctor or pharmacist before using any other cold, cough, allergy, or sleep medicine. Antihistamines are contained in many combination medicines. Taking certain products together can cause you to get too much of a certain drug. Check the label to see if a medicine contains an antihistamine.

Avoid becoming overheated or dehydrated during exercise and in hot weather. Chlorpheniramine can decrease sweating and you may be more prone to heat stroke.

What other drugs will affect chlorpheniramine?

Taking chlorpheniramine with other drugs that make you sleepy or slow your breathing can worsen these effects. Ask your doctor before taking chlorpheniramine with a sleeping pill, narcotic pain medicine, muscle relaxer, or medicine for anxiety, depression, or seizures.

Ask a doctor or pharmacist before using this medicine if you are also using any other drugs, including prescription and over-the-counter medicines, vitamins, and herbal products. Some medicines can cause unwanted or dangerous effects when used together. Not all possible interactions are listed in this medication guide.

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)