Brompheniramine/Dextromethorphan/ Pseudoephedrine

Brompheniramine/dextromethorphan/pseudoephedrine is a combination medication used to control cough and relieve symptoms of common cold, hay fever, and respiratory allergies.

The combo medication temporarily relieves symptoms such as runny nose, nasal congestion, sneezing, itchy nose or throat, itchy/watery eyes, and cough due to minor throat and bronchial irritation, and is available over-the-counter (OTC) and on prescription.

Each of the three medications in the combination works in a different way, and together they are more effective in relieving symptoms, than with the use of any one of the drugs in the combo.

• Brompheniramine works by blocking the activity of histamine, a natural compound in the body that causes allergy symptoms. Histamine is released by mast cells and basophils, types of immune cells, in response to allergen exposure. Brompheniramine binds to histamine H1 receptors in blood vessels, respiratory tract and gastrointestinal tract, preventing their activation by histamine and the resultant allergic reaction.
• Dextromethorphan suppresses cough by reducing the sensitivity of cough receptors in the brain region that stimulate the cough reflex and preventing the transmission of cough impulses. Dextromethorphan is a non-opioid drug derived from levorphanol, an opioid painkiller (analgesic), and is structurally similar to opioid drugs such as codeine, however, it does not have analgesic or addictive properties.
• Pseudoephedrine works by stimulating alpha and beta receptors that regulate contraction of the smooth muscles of the bronchial passage and blood vessels. This results in dilation of the bronchial passage and constriction of blood vessels, reducing congestion and making breathing easier.

• Do not use brompheniramine/dextromethorphan/pseudoephedrine in the following conditions:
  • Hypersensitivity to brompheniramine, dextromethorphan, pseudoephedrine or any of the components in the formulation
  • Severe hypertension or coronary artery disease
  • Acute asthma attack or other lower respiratory tract conditions
  • Narrow-angle glaucoma, an eye condition with high intraocular pressure that progressively damages the optic nerve
  • Symptomatic prostate enlargement (hypertrophy)
  • Bladder neck obstruction
  • Stenosing peptic ulcer
• Do not use brompheniramine/dextromethorphan/pseudoephedrine to treat full term or premature newborn infants
• Do not use concurrently with monoamine oxidase inhibitors, a class of antidepressants
• Use with caution in patients with:
  • Diabetes mellitus
  • Thyroid dysfunction
  • High intraocular pressure
  • Persistent cough related to smoking, asthma or emphysema, or cough with excessive phlegm, unless specifically prescribed
  • Risk for seizures
  • Cardiovascular disease
  • Gastrointestinal obstruction
• May cause depression of central nervous system; advise patients appropriately
• Do not use concurrently with other sedative drugs
• Brompheniramine is a first generation antihistamine that also has effects on the central nervous system and can cause drowsiness, confusion, dry mouth and constipation, particularly in geriatric patients; avoid use in patients older than 65 years of age

Side effects of brompheniramine/dextromethorphan/pseudoephedrine include:

• Impaired coordination, balance and speech (ataxia)
• Insomnia
• Dizziness
• Drowsiness (somnolence)
• Feeling of unease (dysphoria)
• Euphoria
• Irritability
• Nervousness
• Tremor
• Weakness (asthenia)
• Seizure
• Headache
• Dry nose
• Dry throat
• Wheezing
• Thickening of bronchial secretions
• Shortness of breath (dyspnea)
• Chest tightness
• Palpitations
• Irregular heart rhythm (arrhythmia)
• Increase or decrease in blood pressure (hypertension or hypotension)
• Skin reactions that include:
  • Rash
  • Hives (urticaria)
  • Itching (pruritus)
  • Light sensitivity
• Nausea
• Vomiting
• Diarrhea
• Constipation
• Upper abdominal (epigastric) discomfort
• Loss of appetite (anorexia)
• Dry mouth (xerostomia)
• Visual disturbance
• Blood disorders such as:
  • Low count of granulocyte immune cells (agranulocytosis)
  • Low red blood cell count due to rapid destruction (hemolytic anemia)
  • Low platelet count (thrombocytopenia)
• Urinary frequency
• Urinary difficulties

This is not a complete list of all side effects or adverse reactions that may occur from the use of this drug.

Call your doctor for medical advice about serious side effects or adverse reactions. You may also report side effects or health problems to the FDA at 1-800-FDA-1088.

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)

Relief of Nasal Congestion and Cough

Adult:

• Bromfed DM: 2 teaspoonfuls (10 mL) orally every 4 hours; not to exceed 6 doses/day
• Bromdex D: 1 teaspoonful (5 mL) orally every 4 hours; not to exceed 4 doses/day
• Bromaline DM: 4 teaspoonfuls (20 mL) orally every 4-6 hours; not to exceed 4 doses/day

Pediatric:

Bromfed DM:

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

Bromdex D:

• Children under 6 years: As directed by the physician
• Children 6-12 years: 2.5 mL orally every 6 hours prn; not to exceed 4 doses/24 hours
• Children over 12 years: 5 mL orally every 6 hours prn; not to exceed 4 doses/24 hours

Bromaline DM:

• Children under 6 years: As directed by the physician
• Children 6-12 years: 2 teaspoonfuls (10 mL) orally every 4 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

• Overdose of brompheniramine/dextromethorphan/pseudoephedrine can cause severe adverse reactions, particularly in children and elderly patients.
• In case of overdose, seek medical help or contact Poison Control.

Inform your doctor of all medications you are currently taking, who can advise you on any possible drug interactions. Never begin taking, suddenly discontinue, or change the dosage of any medication without your doctor’s recommendation.

• Severe interactions of brompheniramine/dextromethorphan/pseudoephedrine include:
  • dihydroergotamine
  • dihydroergotamine inhaled
  • dihydroergotamine intranasal
  • ergoloid mesylates
  • ergonovine
  • ergotamine
  • isocarboxazid
  • linezolid
  • methylergonovine
  • phenelzine
  • procarbazine
  • rasagiline
  • 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:
  • ashwagandha
  • brimonidine
  • desmopressin
  • eucalyptus

The drug interactions listed above are not all of the possible interactions or adverse effects. For more information on drug interactions, visit the RxList Drug Interaction Checker.

It is important to always tell your doctor, pharmacist, or health care provider of all prescription and over-the-counter medications you use, as well as the dosage for each, and keep a list of the information. Check with your doctor or health care provider if you have any questions about the medication.

• There are no well-controlled studies on the safety of the combo medication brompheniramine/dextromethorphan/pseudoephedrine in pregnant women; use with caution if maternal benefits outweigh possible risks to the fetus
• Brompheniramine/dextromethorphan/pseudoephedrine is present in breast milk; avoid use
• Pregnant and breastfeeding women should consult their healthcare providers before taking any OTC drug

• Follow package instructions exactly while taking OTC drugs; do not take higher or more frequent doses than recommended
• Store brompheniramine/dextromethorphan/pseudoephedrine out of reach of children
• Do not administer OTC brompheniramine/dextromethorphan/pseudoephedrine to children younger than 2 years of age
• Stop taking the medication and see your doctor if:
  • Symptoms do not get better within 7 days
  • Symptoms include fever, rash, or persistent headache
  • You develop sleeplessness, nervousness, or dizziness
• May impair physical and mental abilities. Avoid activities such as driving and operating heavy machinery.
• Avoid alcohol while taking brompheniramine/dextromethorphan/pseudoephedrine