Brompheniramine Maleate, Pseudoephedrine Hydrochloride,

Prescription

Nomes comerciais: Brompheniramine maleate, pseudoephedrine hydrochloride,

Forma Farmacêutica

Liquid/Solution

Via de Administração

ORAL

Fabricante

Eywa Pharma Inc

About This Medication

DESCRIPTION Brompheniramine maleate, pseudoephedrine hydrochloride, and dextromethorphan hydrobromide syrup, 2 mg/30 mg/10 mg per 5 mL is a clear, light pink syrup with a butterscotch flavour. Each 5 mL (1 teaspoonful) contains: Brompheniramine Maleate, USP 2 mg Pseudoephedrine Hydrochloride, USP 30 mg Dextromethorphan Hydrobromide, USP 10 mg Alcohol 0.95% v/v In a palatable, aromatic vehicle. Inactive Ingredients: artificial butterscotch flavor, citric acid anhydrous, alcohol, FD&C Red No. 40, glycerin, sucrose, methylparaben, propylene glycol, purified water and sodium benzoate. It may contain 10% citric acid solution or 10% sodium citrate solution for pH adjustment. The pH range is between 4.0 and 6.0. Brompheniramine Maleate, USP(±)-2- p -Bromo-α-2-(dimethylamino)ethylbenzylpyridine maleate (1:1) Pseudoephedrine Hydrochloride, USP (+)-Pseudoephedrine hydrochloride Dextromethorphan Hydrobromide, USP 3-Methoxy-17-methyl-9α, 13α, 14α-morphinan hydrobromide monohydrate Antihistamine/Nasal Decongestant/Antitussive syrup for oral administration. bromfed-str1 bromfed-str2 bromfed-str3

Princípios Ativos

Ingrediente	Concentração
Brompheniramine Maleate	-
Dextromethorphan Hydrobromide	-
Pseudoephedrine Hydrochloride	-

Indicações e Uso

INDICATIONS AND USAGE For relief of coughs and upper respiratory symptoms, including nasal congestion, associated with allergy or the common cold.

Posologia e Administração

DOSAGE AND ADMINISTRATION 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 Overview

ADVERSE REACTIONS 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.

Advertências e Precauções

WARNINGS 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.

Contraindicações

CONTRAINDICATIONS 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 (MAOI) inhibitors (see PRECAUTIONS - Drug Interactions). Antihistamines should not be used to treat lower respiratory tract conditions including asthma.

Frequently Asked Questions

INDICATIONS AND USAGE For relief of coughs and upper respiratory symptoms, including nasal congestion, associated with allergy or the common cold.

DOSAGE AND ADMINISTRATION 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.

WARNINGS 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.

CONTRAINDICATIONS 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 (MAOI) inhibitors (see PRECAUTIONS - Drug Interactions). Antihistamines should not be used to treat lower respiratory tract conditions including asthma.

Brompheniramine Maleate, Pseudoephedrine Hydrochloride, is a prescription medication. You will need a valid prescription from a licensed healthcare provider.

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References & Data Sources

• DailyMed — Brompheniramine Maleate, Pseudoephedrine Hydrochloride, drug label (National Library of Medicine)
• openFDA — Brompheniramine Maleate, Pseudoephedrine Hydrochloride, label data (U.S. Food & Drug Administration)
• RxNorm — RXCUI 1357010 (NLM Normalized Drug Names)
• NDC Directory — Brompheniramine Maleate, Pseudoephedrine Hydrochloride, (FDA National Drug Code)

Aviso Médico

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Sempre busque o aconselhamento do seu médico ou outro profissional de saúde qualificado para quaisquer dúvidas que você possa ter sobre uma condição médica ou medicamento.

Fontes de dados: DailyMed (NLM), openFDA, MFDS