BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE ORAL SOLUTION

Rx only

Brompheniramine maleate, pseudoephedrine hydrochloride, and dextromethorphan hydrobromide syrup is a clear, sweet, unflavored, pink syrup.

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, methylparaben, purified water, sodium benzoate, sodium citrate dihydrate, and sucrose.

Antihistamine/Nasal Decongestant/Antitussive syrup for oral administration.

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.

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.

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 (MAOI) (see PRECAUTIONS - Drug Interactions).

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.

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.

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

Hematologic System: Hemolytic anemia, thrombocytopenia, agranulocytosis.

To report SUSPECTED ADVERSE REACTIONS, contact PAI Pharma at 1-800-845-8210 or FDA at 1-800-FDA-1088 or HYPERLINK "www.fda.gov/medwatch" www.fda.gov/medwatch.

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.

Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide Syrup is a clear, sweet, unflavored, pink 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:

NDC 0121-0933-04:  4 fl oz (118 mL) bottle

NDC 0121-0933-16:  16 fl oz (473 mL) bottle

MANUFACTURED FOR

PAI Pharma
Greenville, SC 29605

R06/23

NDC 0121- 0933-04

Brompheniramine Maleate,
Pseudoephedrine Hydrochloride
and Dextromethorphan Hydrobromide
Oral Solution
(2 mg/30 mg/10 mg/ per 5 mL)
Alcohol Free٠Sweet٠Unflavored

 Each 5 mL (teaspoonful) contains:
Brompheniramine Maleate, USP .........................  2 mg
Pseudoephedrine Hydrochloride, USP ...............  30 mg
Dextromethorphan Hydrobromide, USP............... 10 mg

Rx only
4 FL OZ (118 mL)
PAI Pharma

NDC 0121- 0933-16

Brompheniramine Maleate,
Pseudoephedrine Hydrochloride and
Dextromethorphan Hydrobromide
Oral Solution
(2 mg/30 mg/10 mg/ per 5 mL)
Alcohol Free٠Sweet٠Unflavored

Each 5 mL (teaspoonful) contains:
Brompheniramine Maleate, USP .........................  2 mg
Pseudoephedrine Hydrochloride, USP ...............  30 mg
Dextromethorphan Hydrobromide, USP............... 10 mg

Rx only
16 FL OZ (473 mL)
PAI Pharma