Brompheniramine/Dextromethorphan/Pseudoephedrine

Brompheniramine/dextromethorphan/pseudoephedrine is an over-the-counter (OTC) product used for relief of nasal congestion and cough.

• Brompheniramine/dextromethorphan/pseudoephedrine is available under the following different brand names: Bromfed-DM.

• (2 mg/10mg/30mg)/5mL (Bromfed DM)
• (3 mg/30mg/50mg)/5mL (Bromdex D) Oral Elixir
• (1 mg/5mg/15mg)/5mL (Bromaline DM)

Dosage Considerations – Should be Given as Follows:
Relief of Nasal Congestion and Cough

• Bromfed DM:
  • Adults: 2 teaspoonfuls (10 mL) orally every 4 hours; not to exceed 6 doses/day
  • Children over 12 years: 2 teaspoonfuls (10 mL) orally every 4 hours; not to exceed 6 doses/day
  • Children 6-12 years: 1 teaspoonful (5 mL) orally every 4 hours; not to exceed 6 doses/day
  • Children 2-6 years: 1/2 teaspoonful (2.5 mL) orally every 4 hours; not to exceed 6 doses/day
  • Children 6 months to 2 years: As directed by physician
  • Children under 6 months: Safety and efficacy not established

• Bromdex D:
  • Adults: 1 teaspoonful (5 mL) orally every 4 hours; not to exceed 4 doses/day
  • Children over 12 years: 5 mL orally every 6 hours prn; not to exceed 4 doses/24 hours
  • Children 6-12 years: 2.5 mL orally every 6 hours prn; not to exceed 4 doses/24 hours
  • Children under 6 years: As directed by physician

• Bromaline DM:
  • Adults: 4 teaspoonfuls (20 mL) orally every 4-6 hours; not to exceed 4 doses/day
  • Children over 12 years: 4 teaspoonfuls (20 mL) orally every 4-6 hours; not to exceed 4 doses/day
  • Children 6-12 years: 2 teaspoonsful (10 mL) orally every 4 hours; not to exceed 4 doses/day
  • Children under 6 years: As directed by physician

Side effects of brompheniramine/dextromethorphan/pseudoephedrine include:

• Dizziness
• Drowsiness
• Dry mouth, throat, and nose
• Thickening of mucus in nose or throat
• Gastrointestinal disturbances
• Irregular heartbeats (arrhythmia)
• Palpitations
• Convulsions
• Excitability
• Tremor
• Weakness

If your doctor has directed you to use this medication, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Severe interactions of brompheniramine/dextromethorphan/pseudoephedrine include:
  • iobenguane I 123
  • isocarboxazid
  • linezolid
  • phenelzine
  • phenelzine
  • procarbazine
  • rasagiline
  • safinamide
  • selegiline
  • selegiline
  • selegiline transdermal
  • tranylcypromine
• Brompheniramine/dextromethorphan/pseudoephedrine has serious interactions with at least 54 different drugs.
• Brompheniramine/dextromethorphan/pseudoephedrine has moderate interactions with at least 273 different drugs.
• Mild interactions of brompheniramine/dextromethorphan/pseudoephedrine include:
  • amiodarone
  • asenapine
  • ashwagandha
  • brimonidine
  • celecoxib
  • chloroquine
  • cimetidine
  • darifenacin
  • desmopressin
  • diphenhydramine
  • dronedarone
  • eucalyptus
  • haloperidol

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist. Check with your physician if you have health questions or concerns.

Warnings
This medication contains brompheniramine/dextromethorphan/pseudoephedrine. Do not take Bromfed-DM if you are allergic to brompheniramine/dextromethorphan/pseudoephedrine or any ingredients contained in this drug.

• Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.

Contraindications

• Hypersensitivity
• Acute asthma attack
• Severe hypertension
• Coronary artery disease
• Narrow-angle glaucoma
• Symptomatic prostate hypertrophy
• Bladder-neck obstruction
• Stenosing peptic ulcer

Effects of Drug Abuse

• No information available

Short-Term Effects

• See "What Are Side Effects Associated with Using Brompheniramine/Dextromethorphan/Pseudoephedrine?”

Long-Term Effects

• See "What Are Side Effects Associated with Using Brompheniramine/Dextromethorphan/Pseudoephedrine?”

Cautions

• 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

• Use brompheniramine/dextromethorphan/pseudoephedrine with caution during pregnancy if the benefits outweigh the risks. Animal studies show risk and human studies are not available or neither animal nor human studies were done.
• Brompheniramine/dextromethorphan/pseudoephedrine is excreted in breast milk. It is not recommended for use while breastfeeding.
• Pregnant or breastfeeding patients should seek the advice of a health professional before using over-the-counter (OTC) drugs.