Get your patient on Brompheniramine, Pseudoephedrine, Dextromethorphan - Brompheniramine, Pseudoephedrine, Dextromethorphan syrup (Brompheniramine, Pseudoephedrine, Dextromethorphan)

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 PRECAUTIONS - Drug Interactions ).
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:

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.

Monoamine oxidase (MAO) inhibitors

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 CONTRAINDICATIONS ).

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.

Brompheniramine maleate, pseudoephedrine hydrochloride and dextromethorphan hydrobromide syrup is a clear, light pink syrup with a butterscotch flavor.
Each 5 mL (1 teaspoonful) contains:
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: dehydrated ethanol, glycerin, sucrose, citric acid anhydrous, spectracol dual FD&C Red No 40, artificial butterscotch flavour, methylparaben, sodium benzoate, propylene glycol, sodium citrate anhydrous and purified water. It may contain 10% sodium citrate solution for pH adjustment. The pH range is between 3.0 and 6.0.

Antihistamine/Nasal Decongestant/Antitussive syrup for oral administration.

Brompheniramine maleate is a histamine antagonist, specifically an H ₁ -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.

Brompheniramine maleate, pseudoephedrine hydrochloride and dextromethorphan hydrobromide syrup is a clear, light pink-colored, butterscotch-flavored syrup containing in each 5 mL (1 teaspoonful) brompheniramine maleate 2 mg, pseudoephedrine hydrochloride 30 mg and dextromethorphan hydrobromide 10 mg, available in the following sizes:

4 fl oz (118 mL) NDC 67877-558-17
1 Pint (473 mL) NDC 67877-558-16

RECOMMENDED STORAGE
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

Manufactured by:
Alkem Laboratories Ltd.,
Mumbai - 400 013, INDIA.
Distributed by:
Ascend Laboratories, LLC
Bedminster, NJ 07921

Revised: January, 2025
PT 2859-02