Brompheniramine, Pseudoephedrine, and Dextromethorphan

Name: Brompheniramine, Pseudoephedrine, and Dextromethorphan

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Trouble passing urine.
  • A fast heartbeat.
  • A heartbeat that does not feel normal.
  • Very bad dizziness or passing out.
  • Shortness of breath.
  • Shakiness.
  • Seizures.
  • Blurred eyesight.

Index Terms

  • Bromphenir/Pseudoeph/Dextrom
  • Dextromethorphan Hydrobromide, Brompheniramine Maleate, and Pseudoephedrine Hydrochloride
  • Pseudoephedrine Tannate, Dextromethorphan Tannate, and Brompheniramine Tannate

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Liquid, Oral:

Brotapp-DM: Brompheniramine maleate 1 mg, pseudoephedrine hydrochloride 15 mg, and dextromethorphan hydrobromide 5 mg per 5 mL (120 mL, 240 mL) [grape flavor]

Q-Tapp DM: Brompheniramine maleate 1 mg, pseudoephedrine hydrochloride 15 mg, and dextromethorphan hydrobromide 5 mg per 5 mL (118 mL [DSC]) [ethanol free; contains propylene glycol, sodium 2 mg/5 mL, sodium benzoate; grape flavor]

Syrup, Oral:

Bromfed DM: Brompheniramine maleate 2 mg, pseudoephedrine hydrochloride 30 mg, and dextromethorphan hydrobromide 10 mg per 5 mL (118 mL, 473 mL) [contains ethanol 0.95%, propylene glycol, sodium benzoate; butterscotch flavor]

Dimetane DX: Brompheniramine maleate 2 mg, pseudoephedrine hydrochloride 30 mg, and dextromethorphan hydrobromide 10 mg per 5 mL (118 mL [DSC]) [contains propylene glycol]

Neo DM: Brompheniramine maleate 3 mg, pseudoephedrine hydrochloride 50 mg, and dextromethorphan hydrobromide 30 mg per 5 mL (473 mL [DSC]) [contains propylene glycol; berry-vanilla flavor]

TGQ 30PSE/3BRM/15DM: Brompheniramine maleate 3 mg, pseudoephedrine hydrochloride 30 mg, and dextromethorphan hydrobromide 15 mg per 5 mL (473 mL) [contains propylene glycol; berry-vanilla flavor]

TGQ 50PSE/3BRM/30DM Brompheniramine maleate 3 mg, pseudoephedrine hydrochloride 50 mg, and dextromethorphan hydrobromide 30 mg per 5 mL (473 mL [DSC]) [contains propylene glycol; berry-vanilla flavor]

Generic: Brompheniramine maleate 2 mg, pseudoephedrine hydrochloride 30 mg, and dextromethorphan hydrobromide 10 mg per 5 mL (118 mL, 473 mL)

Brand Names U.S.

  • Bromfed DM
  • Brotapp-DM [OTC]
  • Dimetane DX [OTC] [DSC]
  • Neo DM [OTC]
  • Q-Tapp DM [OTC] [DSC]
  • TGQ 30PSE/3BRM/15DM
  • TGQ 50PSE/3BRM/30DM [DSC]

Pharmacologic Category

  • Alkylamine Derivative
  • Alpha/Beta Agonist
  • Antitussive
  • Decongestant
  • Histamine H1 Antagonist
  • Histamine H1 Antagonist, First Generation

Contraindications

Hypersensitivity to brompheniramine, pseudoephedrine, dextromethorphan or any component of the formulation; severe hypertension or coronary artery disease; concomitant or within 2 weeks of MAO inhibitor therapy; newborns or premature infants; breast-feeding; treatment of lower respiratory tract conditions, including acute asthma; narrow-angle glaucoma; urinary retention; peptic ulcer disease

OTC labeling: When used for self-medication, do not exceed recommended dose, do not use to sedate a child, and do not use in children 5 years and younger.

Storage

Store at 15°C to 30°C (59°F to 86°F). Protect from light.

Adverse Reactions

Frequency not defined.

Cardiovascular: Cardiac arrhythmia, flushing, hypertension, palpitations, tachycardia

Central nervous system: Convulsions, central nervous system stimulation, dizziness, drowsiness, excitability (children; rare), hallucination, headache, insomnia, irritability, lassitude, nervousness, sedation

Dermatologic: Pallor, pruritus, skin photosensitivity, skin rash, urticaria

Gastrointestinal: Anorexia, constipation, diarrhea, dyspepsia, gastrointestinal irritation, nausea, vomiting, xerostomia

Genitourinary: Dysuria, urinary retention (with BPH)

Hematologic & oncologic: Agranulocytosis, hemolytic anemia, thrombocytopenia

Neuromuscular & skeletal: Tremor, weakness

Ophthalmic: Diplopia

Renal: Polyuria

Respiratory: Dyspnea

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