GUAIFENESIN - ODAAT 1200 MG- guaifenesin tablet 
LODAAT LLC

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LODAAT- GUAIFENESIN - ODAAT 1200 mg CAPLETS (83139-175)

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

GUAIFENESIN 1200MG

PURPOSE

EXPECTORANT

USES

WARNINGS

DO NOT USE

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.

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

OTHER INFORMATION

INACTIVE INGREDIENTS

CARBOMER HOMOPOLYMER TYBE B, HYPROMELLOSE, MAGNESIUM STEARATE, MICROCRYSTALLINE CELLULOSE, SODIUM STARCH GLYCOLATE.

QUESTIONS?

CALL TOLL-FREE +1 630 852 7544

PDP

DF BOX

GUAIFENESIN - ODAAT  1200 MG
guaifenesin tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83139-175
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN1200 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorwhiteScoreno score
ShapeOVALSize21mm
FlavorImprint Code G;1200
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83139-175-01100 in 1 BOTTLE; Type 0: Not a Combination Product03/04/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21342003/04/2023
Labeler - LODAAT LLC (011845714)

Revised: 3/2023
Document Id: f61d3ae0-11ec-2a82-e053-2995a90a95da
Set id: f61d3ae0-11eb-2a82-e053-2995a90a95da
Version: 1
Effective Time: 20230304
 
LODAAT LLC