maximum strength mucus relief severe congestion and cough

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

maximum strength mucus relief severe congestion and cough is an FDA drug label for the active ingredient DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE manufactured by SuperValu Inc., 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 20170901.

Generic name
DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE
Manufacturer
SuperValu Inc.,
Product type
HUMAN OTC DRUG
Route
ORAL
Dosage form
N/A
NDC
41163-738
Application
part341
Label effective
20170901

Active ingredients

Active ingredients (in each 20 mL) Purposes Dextromethorphan HBr 20 mg Cough suppressant Guaifenesin 400 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 • measure only with dosing cup provided • do not use dosing cup with other products • dose as follows or as directed by a doctor • mL = milliliter • Adults and children 12 years of age and older: 20 mL in dosing cup provided every 4 hours. • Children under 12 years of age: Do not use.

Contraindications

Not available.

Warnings

Warnings Do not use • for children under 12 years of age • 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 • trouble urinating due to an enlarged prostate gland • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema • cough that occurs with too much phlegm (mucus) When using this product do not use more than directed Stop use and ask a doctor if • nervousness, dizziness or sleeplessness occur • symptoms do not get better within 7 days or occur with fever • cough comes back, or occurs with rash or persistent headache. These could be signs of a serious condition. 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 1-800-222-1222

Adverse Reactions

Not available.

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