GUAIFENESIN - ODAAT 1200 MG

GUAIFENESIN ORAL HUMAN OTC DRUG

GUAIFENESIN - ODAAT 1200 MG is an FDA drug label for the active ingredient GUAIFENESIN manufactured by LODAAT 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 20230304.

Generic name
GUAIFENESIN
Manufacturer
LODAAT LLC
Product type
HUMAN OTC DRUG
Route
ORAL
Dosage form
N/A
NDC
83139-175
Application
ANDA213420
Label effective
20230304

Active ingredients

ACTIVE INGREDIENT (IN EACH EXTENDED-RELEASE BI-LAYER TABLET) GUAIFENESIN 1200MG

Indications & Usage

USES HELPS LOOSEN PHLEGM (MUCUS) AND THIN BRONCHIAL SECRETIONS TO RID THE BRONCHIAL PASSAGEWAY OF BOTHERSOME MUCUS AND MAKE COUGHS MORE PRODUCTIVE

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 OF AGE AND OVER: TAKE 1 TABLET EVERY 12 HOURS. DO NOT EXCEED 2 TABLETS IN 24 HOURS. CHILDREN UNDER 12 YEARS OF AGE: DO NOT USE.

Warnings

WARNINGS DO NOT USE FOR CHILDREN UNDER 12 YEARS OF AGE ASK DOCTOR BEFORE USE IF YOU HAVE: PERSISTENT OR CHRONIC COUGH SUCH AS OCCURS WITH SMOKING, ASTHMA, CHRONIC BRONCHITIS OR EMPHASEMA (MUCUS) COUGH ACCOMPANIED BY EXCESSIVE PHLEGM STOP USE AND ASK A DOCTOR IS COUGH LASTS FOR MORE THAN 7 DAYS, RECURS, OR IS ACCOMPANIED BY FEVER, RASH, OR PERSISTENT HEADACHE. THESE COULD BE SIGNS OF A SERIOUS CONDITION. IF PREGNANT OR BREAST FEEDING, ASK A HEALTH PROFESSIONAL BEFORE USE.

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