Active Ingredient (In Each Extended-Release Bi-Layer Tablet)
GUAIFENESIN 1200MG
Guaifenesin - Odaat Tablet
FDA Label NDC 83139-175
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Lodaat Llc for the product Guaifenesin - Odaat (NDC 83139-175). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient (in each extended-release bi-layer tablet), purpose, uses, warnings, otc - keep out of reach of children, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
EXPECTORANT
Uses
- HELPS LOOSEN PHLEGM (MUCUS) AND THIN BRONCHIAL SECRETIONS TO RID THE BRONCHIAL PASSAGEWAY OF BOTHERSOME MUCUS AND MAKE COUGHS MORE PRODUCTIVE
Warnings
DO NOT USE
- FOR CHILDREN UNDER 12 YEARS OF AGE
- PERSISTENT OR CHRONIC COUGH SUCH AS OCCURS WITH SMOKING, ASTHMA, CHRONIC BRONCHITIS OR EMPHASEMA (MUCUS)
- COUGH ACCOMPANIED BY EXCESSIVE PHLEGM
- 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.
ASK DOCTOR BEFORE USE IF YOU HAVE:
STOP USE AND ASK A DOCTOR IS
IF PREGNANT OR BREAST FEEDING, ASK A HEALTH PROFESSIONAL BEFORE USE.
Otc - Keep Out Of Reach Of Children
KEEP OUT OF REACH OF CHILDREN. IN CASE OF OVERDOSE, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER (1-800-222-1222) IMMEDIATELY.
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.
Other Information
- STORE BETWEEN 20-25°C (68-77°F)
Inactive Ingredients
CARBOMER HOMOPOLYMER TYBE B, HYPROMELLOSE, MAGNESIUM STEARATE, MICROCRYSTALLINE CELLULOSE, SODIUM STARCH GLYCOLATE.
Questions?
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