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Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide
Overview
What is Brompheniramine Maleate, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide?
Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide 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:
C H BrN •C H O M.W. 435.31 Brompheniramine Maleate, USP (±)-2- -Bromo-α-2-(dimethylamino)ethylbenzylpyridine maleate (1:1)
C H NO•HCl M.W. 201.69 Pseudoephedrine Hydrochloride, USP (+)-Pseudoephedrine hydrochloride
C H NO•HBr•H O 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.
What does Brompheniramine Maleate, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide look like?





What are the available doses of Brompheniramine Maleate, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide?
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What should I talk to my health care provider before I take Brompheniramine Maleate, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide?
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How should I use Brompheniramine Maleate, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide?
Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide Syrup is indicated for relief of coughs and upper respiratory symptoms, including nasal congestion, associated with allergy or the common cold.
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.
What interacts with Brompheniramine Maleate, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide?
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) (see ).
Antihistamines should not be used to treat lower respiratory tract conditions including asthma.
What are the warnings of Brompheniramine Maleate, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide?
R-Gene 10 is a diagnostic aid and is not intended for therapeutic use.
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.
What are the precautions of Brompheniramine Maleate, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide?
General:
Because of its antihistamine component, Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide 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, Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide 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:
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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 Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide Syrup and MAOIs should be avoided (see ).
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Antihistamines have additive effects with alcohol and other CNS depressants (hypnotics, sedatives, tranquilizers, antianxiety agents, etc.).
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Sympathomimetic may reduce the effects of antihypertensive drugs.
Carcinogenesis, Mutagenesis, Impairment of Fertility:
Animal studies of Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide Syrup to assess the carcinogenic and mutagenic potential or the effect on fertility have not been performed.
Pregnancy:
Nursing Mothers:
Because of the higher risk of intolerance of antihistamines in small infants generally, and in newborns and prematures in particular, Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide Syrup is contraindicated in nursing mothers.
Pediatric Use:
Safety and effectiveness in pediatric patients below the age of 6 months have not been established (see
What are the side effects of Brompheniramine Maleate, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide?
The most frequent adverse reactions to Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide Syrup are: sedation; dryness of mouth, nose and throat; thickening of bronchial secretions; dizziness. Other adverse reactions may include:
Dermatologic:
Cardiovascular System:
CNS:
G.U. System:
G.I. System:
Respiratory System:
Hematologic System:
What should I look out for while using Brompheniramine Maleate, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide?
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) (see ).
Antihistamines should not be used to treat lower respiratory tract conditions including asthma.
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.
What might happen if I take too much Brompheniramine Maleate, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide?
How should I store and handle Brompheniramine Maleate, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide?
Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide 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 68788-7123-1Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide 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 68788-7123-1