brompheniramine maleate, pseudoephedrine hydrochloride and dextromethorphan hydrobromide
Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide is a combination medicine containing Brompheniramine Maleate, Dextromethorphan Hydrobromide, and Pseudoephedrine Hydrochloride.
Brompheniramine Maleate and Dextromethorphan Hydrobromide and Pseudoephedrine Hydrochloride · by Pharm Assoc
Generic of Dimetane-Dx
Key facts
- Active ingredient
- Brompheniramine Maleate and Dextromethorphan Hydrobromide and Pseudoephedrine Hydrochloride
- Form
- Solution, Syrup
- Strength
- Brompheniramine Maleate 2MG/5ML; Dextromethorphan Hydrobromide 10MG/5ML; Pseudoephedrine Hydrochloride 30MG/5ML
- Type
- Prescription (Rx)
- Brand or generic
- Generic
- Manufacturer
- Pharm Assoc
- Half-life
- roughly 3 to 16 hours — the label does not give one number, because the elimination half-life depends on urine pH: about 3 to 6 hours when urine pH is 5 (acidic), and about 9 to 16 hours when urine pH is 8 (alkaline) (how long it stays in your system)
- FDA application
- ANDA202940
What is Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide?
From the FDA label:Brompheniramine maleate, pseudoephedrine hydrochloride, and dextromethorphan hydrobromide syrup is a clear, sweet, unflavored, pink syrup. Each 5 mL (1 teaspoonful) contains: Brompheniramine Maleate, USP 2 mg Pseudoephedrine Hydrochloride, USP 30 mg Dextromethorphan Hydrobromide, USP 10 mg Inactive Ingredients: citric acid anhydrous, FD&C Red #40, glycerin, methylparaben, purified water, sodium benzoate, sodium citrate dihydrate, and sucrose. Antihistamine/Nasal Decongestant/Antitussive syrup for oral administration. Brompheniramine Maleate, USP chemical structure Pseudoephedrine Hydrochloride, USP chemical structure Dextromethorphan Hydrobromide, USP chemical structure
How to use
Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide is sold in more than one form (Solution and Syrup), and each is dosed differently. The instructions below come from the FDA label for application ANDA202940 — follow the label that came with the product you were actually prescribed.
Adults and pediatric patients 12 years of age and over: 10 mL (2 teaspoonfuls) every 4 hours. Children 6 to under 12 years of age: 5 mL (1 teaspoonful) every 4 hours. Children 2 to under 6 years of age: 2.5 mL (½ teaspoonful) every 4 hours. Infants 6 months to under 2 years of age: Dosage to be established by a physician. Do not exceed 6 doses during a 24-hour period.
Side effects
The most frequent adverse reactions to brompheniramine maleate, pseudoephedrine hydrochloride, and dextromethorphan hydrobromide syrup are: sedation; dryness of mouth, nose and throat; thickening of bronchial secretions; dizziness. Other adverse reactions may include: Dermatologic: Urticaria, drug rash, photosensitivity, pruritus. Cardiovascular System: Hypotension, hypertension, cardiac arrhythmias, palpitation. CNS: Disturbed coordination, tremor, irritability, insomnia, visual disturbances, weakness, nervousness, convulsions, headache, euphoria, and dysphoria. G.U. System: Urinary frequency, difficult urination. G.I. System: Epigastric discomfort, anorexia, nausea, vomiting, diarrhea, constipation. Respiratory System: Tightness of chest and wheezing, shortness of breath. Hematologic System: Hemolytic anemia, thrombocytopenia, agranulocytosis. Respiratory System: Tightness of chest and wheezing, shortness of breath. Hematologic System: Hemolytic anemia, thrombocytopenia, agranulocytosis. To report SUSPECTED ADVERSE REACTIONS, contact PAI Pharma at 1-800-845-8210 or FDA at 1-800-FDA-1088 or HYPERLINK "http://www.fda.gov/medwatch" www.fda.gov/medwatch.
Warnings
Important safety information
Especially in infants and small children, antihistamines in overdosage may cause hallucinations, convulsions, and death. Antihistamines may diminish mental alertness. In the young child, they may produce excitation.
Who should not take Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide
Hypersensitivity to any of the ingredients. Do not use in the newborn, in premature infants, in nursing mothers, or in patients with severe hypertension or severe coronary artery disease. Do not use dextromethorphan in patients receiving monoamine oxidase inhibitors (MAOI) (see PRECAUTIONS - Drug Interactions ). Antihistamines should not be used to treat lower respiratory tract conditions including asthma.
Overdose — what happens if you take too much
Signs and Symptoms Central nervous system effects from overdosage of brompheniramine may vary from depression to stimulation, especially in children. Anticholinergic effects may be noted. Toxic doses of pseudoephedrine may result in CNS stimulation, tachycardia, hypertension, and cardiac arrhythmias; signs of CNS depression may occasionally be seen. Dextromethorphan in toxic doses will cause drowsiness, ataxia, nystagmus, opisthotonos, and convulsive seizures. Toxic Doses Data suggest that individuals may respond in an unexpected manner to apparently small amounts of a particular drug. A 2½-year-old child survived the ingestion of 21 mg/kg of dextromethorphan exhibiting only ataxia, drowsiness, and fever, but seizures have been reported in 2 children following the ingestion of 13–17 mg/kg. Another 2½-year-old child survived a dose of 300–900 mg of brompheniramine. The toxic dose of pseudoephedrine should be less than that of ephedrine, which is estimated to be 50 mg/kg. Treatment Induce emesis if patient is alert and is seen prior to 6 hours following ingestion. Precautions against aspiration must be taken, especially in infants and small children. Gastric lavage may be carried out, although in some instances tracheostomy may be necessary prior to lavage. Naloxone hydrochloride 0.005 mg/kg intravenously may be of value in reversing the CNS depression that may occur from an…
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
Interactions
Monoamine oxidase inhibitors (MAOI) Hyperpyrexia, hypotension, and death have been reported coincident with the coadministration of MAOI and products containing dextromethorphan. In addition, MAOI prolong and intensify the anticholinergic (drying) effects of antihistamines and may enhance the effect of pseudoephedrine. Concomitant administration of brompheniramine maleate, pseudoephedrine hydrochloride, and dextromethorphan hydrobromide syrup and MAOI should be avoided (see CONTRAINDICATIONS ). Central nervous system (CNS) depressants Antihistamines have additive effects with alcohol and other CNS depressants (hypnotics, sedatives, tranquilizers, antianxiety agents, etc.). Antihypertensive drugs Sympathomimetic may reduce the effects of antihypertensive drugs.
How long does Brompheniramine Maleate and Dextromethorphan Hydrobromide and Pseudoephedrine Hydrochloride stay in your body?
The elimination half-life of brompheniramine maleate and dextromethorphan hydrobromide and pseudoephedrine hydrochloride is roughly 3 to 16 hours — the label does not give one number, because the elimination half-life depends on urine pH: about 3 to 6 hours when urine pH is 5 (acidic), and about 9 to 16 hours when urine pH is 8 (alkaline) — the time it takes the body to clear about half of it. As a rule of thumb, a medicine is mostly gone after roughly 4 to 5 half-lives, though this varies from person to person with age and kidney or liver function. This is a genuinely variable half-life, not a fixed one. Pseudoephedrine is cleared mostly unchanged by the kidneys (55% to 96% of a dose appears unchanged in urine), and because it is a base, acidic urine traps and flushes it out faster while alkaline urine lets it be reabsorbed — hence the 3-6 h vs 9-16 h spread the label reports. No active metabolite to worry about: the label says less than 1% is metabolized in the liver, by N-demethylation, to an INACTIVE metabolite. It is not a prodrug. Kidney impairment: because clearance is renal, the label states pseudoephedrine "may accumulate in patients with renal impairment," and the product is to be generally avoided in these patients — expect a longer half-life, though the label does not quantify it. Liver impairment: no studies of pseudoephedrine were conducted in hepatic impairment, so the label gives no number; the product is likewise to be generally avoided. Older adults: this label gives no separate pseudoephedrine half-life for people 65+ (its geriatric pharmacokinetic data covers the antihistamine component only), but it warns that older adults are more likely to have adverse reactions to sympathomimetic amines. The half-life above is from the Clarinex-D 12 Hour label, which is where FDA-approved pseudoephedrine pharmacokinetics are published; standalone OTC pseudoephedrine products carry monograph "Drug Facts" labels that contain no pharmacokinetics section at all.
This is general information, not medical advice. It doesn’t tell you when a drug test would read negative (tests detect substances for different, often longer, windows) or when it’s safe to take another dose — ask your pharmacist or prescriber. Source: CLARINEX-D 12 HOUR (desloratadine and pseudoephedrine sulfate) extended release tablets — Section 12.3 Pharmacokinetics, DailyMed.
Dosage forms
Solution and Syrup
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
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Frequently asked questions
- Is there a coupon or discount for Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide. To pay less, Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide is already a generic — usually the lowest-cost version — so the main levers are comparing cash prices between pharmacies and using a pharmacy discount-card service. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide?
- Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide is marketed by Pharm Assoc. You can see Pharm Assoc's full profile, rating, and other products on pharmaranks.
- Is Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide a brand-name or generic drug?
- Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide is a generic medication; its active ingredient is Brompheniramine Maleate and Dextromethorphan Hydrobromide and Pseudoephedrine Hydrochloride. Generics contain the same active ingredient as the brand-name original and are usually lower cost.
- Is Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide available over the counter?
- No. Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide come in?
- Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide is currently marketed as solution and syrup, per the FDA's National Drug Code Directory.
- Is Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide FDA-registered?
- Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide is on record with the U.S. FDA under application number ANDA202940. You can verify this on its official FDA label.
- Is Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide safe?
- There's no single safe-or-not verdict, and we don't yet have a composite recall-safety score for Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide. Review its FDA-label side effects and warnings below, and always consult a licensed professional.
- What are the side effects of Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide?
- Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide's side effects are taken directly from its FDA label. From the label: The most frequent adverse reactions to brompheniramine maleate, pseudoephedrine hydrochloride, and dextromethorphan hydrobromide syrup are: sedation; dryness of mouth, nose and throat; thickening of bronchial secretions; dizziness. Other adverse reactions may include: Dermatologic: Urticaria,… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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