A light green and clear capsule containing white beads.
Extended-Release.
Each capsule contains:
Brompheniramine maleate ...................................... 12 mg
Pseudoephedrine hydrochloride ........................... 120 mg
in a specially prepared base to provide prolonged action.
A dark green and clear capsule containing white beads.
Extended-Release.
Each capsule contains:
Brompheniramine maleate ........................................ 6 mg
Pseudoephedrine hydrochloride ............................. 60 mg
in a specially prepared base to provide prolonged action.
BROMFED® AND BROMFED-PD® CAPSULES also contain as inactive ingredients: Calcium Stearate, D&C Yellow #10, FD&C Blue #1, FD&C Yellow #6, Gelatin, Pharmaceutical Glaze, Starch, Sucrose and Talc.
BROMFED® AND BROMFED-PD® contain ingredients of the following therapeutic classes: antihistamine and decongestant.
Brompheniramine maleate is an alkylamine-type antihistamine. This group of antihistamines are among the most active histamine antagonists and are generally effective in relatively low doses. The drugs are not so prone to produce drowsiness and are among the most suitable agents for daytime use; but again, a significant proportion of patients do experience this effect. Pseudoephedrine hydrochloride is a sympathomimetic which acts predominantly on alpha receptors and has little action on beta receptors. It therefore functions as an oral nasal decongestant with minimal central nervous system (CNS) stimulation.
For the treatment of the symptoms of seasonal and perennial allergic rhinitis, and vasomotor rhinitis, including nasal obstruction (congestion).
Hypersensitivity to any of the ingredients. Also contraindicated in patients with severe hypertension, severe coronary artery disease, patients on monoamine oxidase (MAO) inhibitor therapy, patients with narrow-angle glaucoma, urinary retention, peptic ulcer and during an asthmatic attack.
Considerable caution should be exercised in patients with hypertension, diabetes mellitus, ischemic heart disease, hyperthyroidism, increased intraocular pressure and prostatic hypertrophy. The elderly (60 years and older) are more likely to exhibit adverse reactions.
Antihistamines may cause excitability, especially in pediatric patients. At dosages higher than the recommended dose, nervousness, dizziness or sleeplessness may occur.
General: Caution should be exercised in patients with high blood pressure, heart disease, diabetes or thyroid disease. The antihistamine in this product may exhibit additive effects with other CNS depressants, including alcohol.
Information for Patients: Antihistamines may cause drowsiness. Ambulatory patients who operate machinery or motor vehicles should be cautioned accordingly.
Drug Interactions: MAO inhibitors and beta adrenergic blockers increase the effects of sympathomimetics. Sympathomimetics may reduce the antihypertensive effects of methyldopa, mecamylamine, reserpine and veratrum alkaloids. Concomitant use of antihistamines with alcohol and other CNS depresssants may have an additive effect.
The safety or use of this product in pregnancy has not been established.
Adverse reactions include drowsiness, lassitude, nausea, giddiness, dryness of the mouth, blurred vision, cardiac palpitations, flushing, increased irritability or excitement (especially in pediatric patients).
Pediatric Use: Antihistamines may cause excitability especially in the pediatric population. Safety and effectiveness of Bromfed® Capsules has not been established in pediatric patients less than 12 years of age, and safety and effectiveness of Bromfed-PD® Capsules has not been established in pediatric patients less than 6 years of age. See Contraindications , , and Precautions for complete information.
KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. IN CASE OF SUSPECTED OVERDOSE, IMMEDIATELY CALL YOUR REGIONAL POISON CONTROL CENTER AND/OR SEEK PROFESSIONAL ASSISTANCE.
Symptoms of overdosage may be caused by pseudoephedrine. Symptoms of overdosage with pseudoephedrine include anxiety, tenseness, respiratory difficulty, headache and awareness of the slow forceful heartbeat.
Treatment of Overdose: The stomach should be emptied promptly by emetics and/or gastric lavage. The installation of activated charcoal also should be considered. Cardiac function and serum electrolytes should be monitored and treatment instituted if indicated. If convulsions or marked CNS excitement occurs, diazepam may be used.
BROMFED® CAPSULES
Adults and pediatric patients 12 years of age and over: 1 capsule every 12 hours.
BROMFED-PD® CAPSULES
Pediatric patients 6 to under 12 years of age: 1 capsule every 12 hours. Adults and pediatric patients 12 years of age and over: 1-2 capsules every 12 hours.
BROMFED® CAPSULES
Bottle of 100
(NDC 0451-4000-50).
Bottle of 500
(NDC 0451-4000-60).
Each capsule is coded "BROMFED" "MURO 12-120."
BROMFED-PD® CAPSULES
Bottle of 100
(NDC 0451-4001-50).
Bottle of 500
(NDC 0451-4001-60).
Each capsule is coded "BROMFED-PD" "MURO 6-60."
Dispense in tight, child-resistant containers as defined in USP/NF. Store at controlled room temperature between 15°-30°C (59°-86°F).
Keep this and all drugs out of reach of children.
Dist. by:
MURO
Pharmaceutical, Inc.
an ASTA Medica company
Tewksbury, MA
01876-1496
Mfd. by:
PharmaFab
Grand Prairie, TX 75050
I-4000-19 PIN010801
11/99