GUAIFENESIN- guaifenesin tablet, extended release 
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)

  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

WARNINGS


Do not use

  • for children under 12 years of age

ASK A DOCTOR BEFORE USE IF YOU HAVE

  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • cough accompanied by too much phlegm (mucus)

STOP USE AND ASK DOCTOR IF

  • cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious illness.

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

  • do not crush, chew, or break tablet
  • take with a full glass of water
  • this product can be administered without regard for timing of meals
  • adults and children 12 years of age and over: 1 or 2 tablets every 12 hours. Do not exceed 4 tablets in 24 hours(For 600mg)
  • adults and children 12 years of age and over: 1 tablet every 12 hours. Do not exceed 2 tablets in 24 hours.(For 1200mg)
  • children under 12 years of age: do not use

OTHER INFORMATION

  •  Tamper evident: Do not use if carton is open or if printed seal on blister is broken or missing.
  •   store between 20-25°C (68-77°F)

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-ER-1200-mg-bulk-labelguaifenesin-label-31-jpg62207-570-30.jpg.jpg62207-570-92.jpg.jpgguaifenesin-1200mg-label-jpg

GUAIFENESIN 
guaifenesin tablet, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62207-569
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:62207-569-994200 in 1 BAG; Type 0: Not a Combination Product02/01/2021
2NDC:62207-569-935 in 1 BOX11/17/2021
22000 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21342002/01/2021
GUAIFENESIN 
guaifenesin tablet, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62207-570
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:62207-570-924000 in 1 BAG; Type 0: Not a Combination Product02/01/2021
2NDC:62207-570-3020000 in 1 BAG; Type 0: Not a Combination Product02/01/2021
3NDC:62207-570-315400 in 1 BAG; Type 0: Not a Combination Product09/30/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21342002/01/2021
Labeler - Granules India Ltd (915000087)
Establishment
NameAddressID/FEIBusiness Operations
Granules India Ltd918609236analysis(62207-569, 62207-570) , label(62207-569, 62207-570) , manufacture(62207-569, 62207-570) , pack(62207-569, 62207-570)

Revised: 11/2021
Document Id: d0f87645-f971-38cd-e053-2995a90a348d
Set id: ba7c1e26-b7d0-4aea-e053-2a95a90a903e
Version: 4
Effective Time: 20211117
 
Granules India Ltd