GUAIFENESIN 400MG CAPLETS- guaifenesin tablet 
Gendose Pharmaceuticals, LLC

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GENDOSE - GUAIFENESIN 400 mg CAPLETS (77333-360)

ACTIVE INGREDIENT (IN EACH CAPLET)

GUAIFENESIN 400MG

PURPOSE

EXPECTORANT

USES

WARNINGS

ASK DOCTOR BEFORE USE IF YOU HAVE:

WHEN USING THIS PRODUCT

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

CROSCARMELLOSE SODIUM, MAGNESIUM STEARATE, MALTODEXTRIN, STEARIC ACID, MICROCRYSTALLINE CELLULOSE, POVIDONE, SILICON DIOXIDE

01b LBL_Guaifenesin_NDC 77333-360-10

GUAIFENESIN 400MG CAPLETS 
guaifenesin tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77333-360
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN400 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorwhiteScoreno score
ShapeOVAL (CAPLET) Size14mm
FlavorImprint Code G400
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:77333-360-10100 in 1 BOX09/02/2022
1NDC:77333-360-251 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01209/02/2022
Labeler - Gendose Pharmaceuticals, LLC (080257510)

Revised: 1/2024
Document Id: 0e768c1f-3c9c-c128-e063-6294a90a4463
Set id: e7b82ec7-ef23-50c1-e053-2a95a90a662f
Version: 5
Effective Time: 20240108
 
Gendose Pharmaceuticals, LLC