DEXTROMETHORPHAN HYDROBROMIDE, Guaifenesin, and PHENYLEPHRINE HYDROCHLORIDE

DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE ORAL HUMAN OTC DRUG

DEXTROMETHORPHAN HYDROBROMIDE, Guaifenesin, and PHENYLEPHRINE HYDROCHLORIDE is an FDA drug label for the active ingredient DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE manufactured by Westminster Pharmaceuticals, LLC administered by ORAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20180314.

Generic name
DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE
Manufacturer
Westminster Pharmaceuticals, LLC
Product type
HUMAN OTC DRUG
Route
ORAL
Dosage form
N/A
NDC
69367-184
Application
M012
Label effective
20180314

Active ingredients

Active ingredients (in each 15 mL (TBSP) Purpose Dextromethorphan HBr 18 mg Cough Suppressant Guaifenesin 200 mg Expectorant Phenylephrine HCl 10 mg Nasal Decongestant

Indications & Usage

Uses helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive temporarily relieves: cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants the intensity of coughing the impulse to cough to help you get to sleep nasal congestion due to a cold

Dosage & Administration

Directions do not take more than 6 doses in any 24-hour period use enclosed dosage cup or tablespoon (TBSP) dose as follows or as directed by a doctor Adults and children 12 years of age and over: 15 mL (1 TBSP) every 4 hours, not to exceed 90 mL (6 TBSP) in a 24 hour period Children 6 to under 12 years of age: 7.5 mL (1/2 TBSP) every 4 hours, not to exceed 45 mL (3 TBSP) in a 24 hour period. Children under 6 years of age: Consult a doctor.

Contraindications

Not available.

Warnings

Warnings Do Not Use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have heart disease high blood pressure thyroid disease diabetes a cough that lasts or is chronic such as occurs with smoking, asthma, or emphysema a cough that occurs with too much phlegm (mucus) difficulty in urination due to enlargement of the prostate gland When using this product do not use more than directed Stop use and ask a doctor if nervousness, dizziness or sleeplessness occurs symptoms do not improve within 7 days or are accompanied by a fever, rash or persistent headache. A persistent cough may be a sign of a serious condition. new symptoms occur If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Adverse Reactions

Not available.

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