Classes
DEA Class; OTC, Rx
Common Brand Names; Bromfed-DM
- Cough/Cold, Non-narcotic Combos;
- Antihistamine/Antitussive/Decongestant Combos
Description
Oral combination of an antihistamine, nasal decongestant, and antitussive
Used for the treatment of cough and upper respiratory symptoms due to seasonal allergic rhinitis or the common cold
May cause increased blood pressure and/or sedation; excitability may occur, especially in children
Indications
Indicated for the treatment of cough and upper respiratory symptoms due to seasonal allergic rhinitis or the common cold, including sneezing, rhinorrhea, itching of the nose and throat, nasal congestion, and itchy, watery eyes.
Contraindications
- Hypersensitivity
- Acute asthma attack
- Severe hypertension
- Coronary artery disease
- Narrow-angle glaucoma
- Symptomatic prostate hypertrophy
- Bladder-neck obstruction
- Stenosing peptic ulcer
Adverse Effects
- Dizziness
- Drowsiness
- Dry mouth, throat, and nose
- Thickening of mucus in nose or throat
- GI disturbances
- Arrhythmia
- Palpitations
- Convulsion
- Excitability
- Tremor
- Weakness
Warnings
Brompheniramine: May cause significant confusional symptoms; not for administration to premature or full-term neonates
Dextromethorphan: Do not take for persistent or chronic cough associated with smoking, asthma, or emphysema, or if it is accompanied by excessive phlegm unless directed by a healthcare provider; may decrease respiration rate
Pseudoephedrine: Caution in cardiovascular disease, diabetes mellitus, prostatic hypertrophy and increased intraocular pressure
Pregnancy and Lactation
Pregnancy category: C
Lactation: excreted in breast milk/not recommended
Pregnant or breastfeeding patients should seek advice of health professional before using OTC drugs
Maximum Dosage
24 mg/day PO brompheniramine; 360 mg/day PO pseudoephedrine; 120 mg/day PO dextromethorphan.
24 mg/day PO brompheniramine; 360 mg/day PO pseudoephedrine; 120 mg/day PO dextromethorphan.
24 mg/day PO brompheniramine; 360 mg/day PO pseudoephedrine; 120 mg/day PO dextromethorphan.
12 years: 24 mg/day PO brompheniramine; 360 mg/day PO pseudoephedrine; 120 mg/day PO dextromethorphan.
6 to 11 years: 12 mg/day PO brompheniramine; 180 mg/day PO pseudoephedrine; 60 mg/day PO dextromethorphan.
2 to 5 years: 6 mg/day PO brompheniramine; 90 mg/day PO pseudoephedrine; 30 mg/day PO dextromethorphan.
1 year: Safety and efficacy have not been established.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
How supplied
Brompheniramine/dextromethorphan/pseudoephedrine
oral syrup
- (2 mg/10mg/30mg)/5mL (Bromfed DM)
- (3 mg/30mg/50mg)/5mL (Bromdex D)
oral elixir
- (1 mg/5mg/15mg)/5mL (Bromaline DM)
