GUAIFENESIN 400MG CAPLETS- guaifenesin tablet

GUAIFENESIN 400MG CAPLETS by

Drug Labeling and Warnings

GUAIFENESIN 400MG CAPLETS by is a Otc medication manufactured, distributed, or labeled by Gendose Pharmaceuticals, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

WHEN USING THIS PRODUCT

• DO NOT EXCEED RECOMMENDED DOSAGE
• DO NOT USE FOR MORE THAN 7 DAYS

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.

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

GUAIFENESIN 400MG CAPLETS 
guaifenesin tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77333-360
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	400 mg

Inactive Ingredients
Ingredient Name	Strength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
STEARIC ACID (UNII: 4ELV7Z65AP)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POVIDONE (UNII: FZ989GH94E)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Product Characteristics
Color	white	Score	no score
Shape	OVAL (CAPLET)	Size	14mm
Flavor		Imprint Code	G400
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77333-360-10	100 in 1 BOX	09/02/2022
1	NDC: 77333-360-25	1 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	09/02/2022

Labeler - Gendose Pharmaceuticals, LLC (080257510)