GUAIFENESIN- guaifenesin tablet, extended release 
GRANULES PHARMACEUTICALS INC.

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Guaifenesin Extended-Release Tablets 600mg and 1200mg

ACTIVE INGREDIENT(S)

Guaifenesin 600 mg (for 600mg)

PURPOSE

Expectorant

USE(S)

WARNINGS


Do not use

ASK A DOCTOR BEFORE USE IF YOU HAVE

STOP USE AND ASK DOCTOR IF

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 right away
(1-800-222-1222)

DIRECTIONS

OTHER INFORMATION

INACTIVE INGREDIENTS

carbomer homopolymer type B; hypromellos, magnesium stearate,  microcrystalline cellulose, sodium starch glycolate

QUESTIONS OR COMMENTS


Contact 1-877-770-3183
Mon-Fri 8:00 AM EST to 5:00 PM PST.

All trademarks are property of their respective owners.MUCINEX is the registered trademark of Reckitt Benckiser LLC.

PRINCIPAL DISPLAY PANEL

600-mg-500-tablets

GUAIFENESIN 
guaifenesin tablet, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70010-199
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN600 mg
Inactive Ingredients
Ingredient NameStrength
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) (UNII: Z135WT9208)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4)  
HYPROMELLOSE 2910 (10000 MPA.S) (UNII: 0HO1H52958)  
Product Characteristics
ColorwhiteScoreno score
ShapeOVALSize16mm
FlavorImprint Code G;600
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70010-199-05500 in 1 BOTTLE; Type 0: Not a Combination Product08/19/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21342008/19/2022
Labeler - GRANULES PHARMACEUTICALS INC. (079825711)

Revised: 7/2024
Document Id: 1cba14de-cac6-e5f3-e063-6294a90ab154
Set id: e6994e38-2a21-4bcf-e053-2995a90a0854
Version: 3
Effective Time: 20240708
 
GRANULES PHARMACEUTICALS INC.