Active Ingredient (In Each Caplet)
GUAIFENESIN 400MG
Guaifenesin 400mg Caplets Tablet
FDA Label NDC 77333-360
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Gendose Pharmaceuticals, Llc for the product Guaifenesin 400mg Caplets (NDC 77333-360). 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 caplet), 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.
- HELPS MAKE COUGHS MORE PRODUCTIVE
Warnings
ASK DOCTOR BEFORE USE IF YOU HAVE:
- PERSISTENT OR CHRONIC COUGH SUAH AS OCCURS WITH SMOKING, ASTHMA, CHRONIC BRONCHITIS OR EMPHASEMA (MUCUS)
- COUGH ACCOMPANIED BY EXCESSIVE PHLEGM
- DO NOT EXCEED RECOMMENDED DOSAGE
- DO NOT USE FOR MORE THAN 7 DAYS
- 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.
WHEN USING THIS PRODUCT
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
- ADULTS AND CHILDREN 12 YEARS OF AGE AND OLDER TAKE 1 CAPLET EVERY 4 HOURS WITH A FULL GLASS OF WATER WHILE SYMPTOMS PERSIST.
- CHILDREN UNDER 12 YEARS OF AGE DO NOT USE.
Other Information
- STORE AT 25°C (77°F) EXCURSIONS BETWEEN 15° - 30° C (59° - 86°F)
- KEEP IN A DRY PLACE AND DO NOT EXPOSE TO HEAT
Inactive Ingredients
CROSCARMELLOSE SODIUM, MAGNESIUM STEARATE, MALTODEXTRIN, STEARIC ACID, MICROCRYSTALLINE CELLULOSE, POVIDONE, SILICON DIOXIDE
* Please review the disclaimer below.
