Brompheniramine Maleate, Pseudoephedrine Hydrochloride, And Dextromethorphan Hydrobromide
Brompheniramine Maleate, Pseudoephedrine Hydrochloride, And Dextromethorphan Hydrobromide Prescribing Information
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.
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 (MAOI) inhibitors (see
Hyperpyrexia, hypotension, and death have been reported coincident with the coadministration of MAO inhibitors and products containing dextromethorphan. In addition, MAO inhibitors 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 MAO inhibitors should be avoided (see
Antihistamines have additive effects with alcohol and other CNS depressants (hypnotics, sedatives, tranquilizers, antianxiety agents, etc.).
Sympathomimetic may reduce the effects of antihypertensive drugs.
Antihistamines should not be used to treat lower respiratory tract conditions including asthma.
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:
Hyperpyrexia, hypotension, and death have been reported coincident with the coadministration of MAO inhibitors and products containing dextromethorphan. In addition, MAO inhibitors 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 MAO inhibitors should be avoided (see
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 (MAOI) inhibitors (see
Antihistamines should not be used to treat lower respiratory tract conditions including asthma.
Brompheniramine maleate, pseudoephedrine hydrochloride and dextromethorphan hydrobromide syrup is a clear, light pink syrup with a butterscotch flavor.
| Brompheniramine Maleate, USP | 2 mg |
| Pseudoephedrine Hydrochloride, USP | 30 mg |
| Dextromethorphan Hydrobromide, USP | 10 mg |
| Alcohol 0.95% v/v | |
In a palatable, aromatic vehicle.
Inactive Ingredients: citric acid anhydrous, dehydrated alcohol, FD&C Red No. 40, glycerin, methylparaben, propylene glycol, purified water, sodium benzoate, and sucrose with butterscotch flavor. It may contain sodium citrate for pH adjustment. The pH range is between 4.0 and 6.0.
C
16H
19BrN
2∙C
4H
4O
4
M.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.