Guaifenesin and Pseudoephedrine Hydrochloride

Guaifenesin and Pseudoephedrine Hydrochloride is an FDA drug label for the active ingredient GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE manufactured by PUBLIX SUPER MARKETS, 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 20220408.

Generic: GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE

Manufacturer: PUBLIX SUPER MARKETS, INC

Product Type: HUMAN OTC DRUG

Route: ORAL

Dosage Form:

NDC: 41415-994

Application: ANDA212542

Effective: 20220408

Active Ingredients: Active ingredients (in each extended-release tablet) Purposes Guaifenesin 600 mg Expectorant Pseudoephedrine HCl 60 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 nasal congestion due to: common cold hay fever upper respiratory allergies temporarily restores freer breathing through the nose promotes nasal and/or sinus drainage temporarily relieves sinus congestion and pressure

Dosage & Administration

Directions do not crush, chew, or break extended-release tablet take with a full glass of water this product can be administered without regard for timing of meals adults and children 12 years and older: 2 extended-release tablets every 12 hours; not more than 4 extended-release tablets in 24 hours children under 12 years of age: do not use

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 trouble urinating due to an enlarged prostate gland persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema cough accompanied by too much phlegm (mucus) When using this product do not use more than directed Stop use and ask a doctor if you get nervous, dizzy, or sleepless symptoms do not get better within 7 days, come back or occur with a fever, rash, or persistent headache. These could be signs of a serious illness. 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