Guaifenesin and Pseudoephedrine HCl

GUAIFENESIN AND PSEUDOEPHEDRINE HCL ORAL HUMAN OTC DRUG

Guaifenesin and Pseudoephedrine HCl is an FDA drug label for the active ingredient GUAIFENESIN AND PSEUDOEPHEDRINE HCL manufactured by KROGER COMPANY 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 20231201.

Generic name
GUAIFENESIN AND PSEUDOEPHEDRINE HCL
Manufacturer
KROGER COMPANY
Product type
HUMAN OTC DRUG
Route
ORAL
Dosage form
N/A
NDC
30142-137
Application
ANDA213203
Label effective
20231201

Active ingredients

Active ingredients (in each extended-release tablet) Guaifenesin USP 600 mg Pseudoephedrine HCl USP 60 mg

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 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 tablets every 12 hours; not more than 4 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.

Adverse Reactions

Not available.