GUAIFENESIN EXTENDED-RELEASE TABLETS, 600MG- guaifenesin extended-release tablet 
GUAIFENSIN EXTENDED-RELEASE TABLETS, 1200 MG- guaifensin extended-release tablet 
Granules India Ltd

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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

 Tamper evident: Do not use if carton is open or if printed seal on blister is broken or missing.

INACTIVE INGREDIENTS

carbomer homopolymer type B; hypromellose, Lake of FD&C Blue 1, 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.

STORAGE

store between 20-25°C (68-77°F)

PRINCIPAL DISPLAY PANEL

guaifenesin-label600-jpg

guaifenesin-label1200-jpg
GUAIFENESIN EXTENDED-RELEASE TABLETS, 600MG 
guaifenesin extended-release tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62207-697
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, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
Product Characteristics
Colorblue (white and blue) Scoreno score
ShapeOVALSize16mm
FlavorImprint Code G;600
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62207-697-729 in 1 CARTON09/10/2020
110 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21342009/10/2020
GUAIFENSIN EXTENDED-RELEASE TABLETS, 1200 MG 
guaifensin extended-release tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62207-698
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, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
Product Characteristics
Colorblue (white-blue) Scoreno score
ShapeOVALSize22mm
FlavorImprint Code G;1200
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62207-698-717 in 1 CARTON09/10/2020
110 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21342009/10/2020
Labeler - Granules India Ltd (915000087)
Establishment
NameAddressID/FEIBusiness Operations
Granules India Ltd918609236manufacture(62207-697, 62207-698) , analysis(62207-697, 62207-698) , pack(62207-697, 62207-698) , label(62207-697, 62207-698)

Revised: 2/2023
Document Id: f4cf2396-f17a-76ab-e053-2995a90a3232
Set id: cea4dba6-9839-40a1-a328-f7c6aeb69d0c
Version: 2
Effective Time: 20230216
 
Granules India Ltd