GUAIFENESIN - ODAAT 1200 MG- guaifenesin tablet

GUAIFENESIN - ODAAT by

Drug Labeling and Warnings

GUAIFENESIN - ODAAT by is a Otc medication manufactured, distributed, or labeled by LODAAT LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

GUAIFENESIN 1200MG

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

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.

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?

CALL TOLL-FREE +1 630 852 7544

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

GUAIFENESIN - ODAAT  1200 MG
guaifenesin tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83139-175
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	1200 mg

Inactive Ingredients
Ingredient Name	Strength
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)

Product Characteristics
Color	white	Score	no score
Shape	OVAL	Size	21mm
Flavor		Imprint Code	G;1200
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83139-175-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	03/04/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA213420	03/04/2023

Labeler - LODAAT LLC (011845714)