GUAIFENESIN- guaifenesin tablet, extended release 
Granules India Ltd

----------

Guaifenesin Extended-Release Tablets 600mg and 1200mg

ACTIVE INGREDIENT(S)

Guaifenesin 600 mg (for 600mg)
 
Guaifenesin 1200 mg (for 1200 mg)

PURPOSE

Expectorant

USE(S)

WARNINGS


Do not use

ASK A DOCTOR BEFORE USE IF YOU HAVE

STOP USE AND ASK DOCTOR IF

PREGNANCY/BREASTFEEDING

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

guaifenesin-1200mg-jpgguaifenesin-600mg-jpg

guaifenesin-label3-jpgguaifenesin-foil-jpgguaifenesin-foil2-jpg

1200-mg-bulk-label

GUAIFENESIN 
guaifenesin tablet, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62207-839
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN600 mg
Inactive Ingredients
Ingredient NameStrength
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) (UNII: Z135WT9208)  
HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4)  
SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
Product Characteristics
ColorwhiteScoreno score
ShapeOVALSize16mm
FlavorImprint Code G;600
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62207-839-729 in 1 CARTON12/18/2020
110 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21342012/18/2020
GUAIFENESIN 
guaifenesin tablet, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62207-840
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 SUCROSE CROSSLINKED) (UNII: Z135WT9208)  
HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4)  
SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
Product Characteristics
ColorwhiteScoreno score
ShapeOVAL (Elliptical) Size22mm
FlavorImprint Code G;1200
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62207-840-717 in 1 CARTON12/18/2020
110 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:62207-840-994200 in 1 BAG; Type 0: Not a Combination Product12/18/2020
3NDC:62207-840-9310000 in 1 BOX; Type 0: Not a Combination Product10/31/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21342012/18/2020
Labeler - Granules India Ltd (915000087)
Establishment
NameAddressID/FEIBusiness Operations
Granules India Ltd918609236analysis(62207-839, 62207-840) , label(62207-839, 62207-840) , manufacture(62207-839, 62207-840) , pack(62207-839, 62207-840)

Revised: 1/2023
Document Id: f3387972-27b9-5186-e053-2995a90a41f1
Set id: e3531e9e-2ae7-4188-b95a-90f35613fc05
Version: 6
Effective Time: 20230126
 
Granules India Ltd