FDA Label for Guaifenesin 400mg Caplets
View Indications, Usage & Precautions
Guaifenesin 400mg Caplets Product Label
The following document was submitted to the FDA by the labeler of this product Gendose Pharmaceuticals, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient (In Each Caplet)
GUAIFENESIN 400MG
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
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