GUAIFENESIN- guaifenesin tablet, extended release 
GRANULES USA, INC.

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Guaifenesin
Extended-Release Tablets 600 mg
Expectorant
12 HR

Active ingredients (in each extended-release bi-layer tablet)

Guaifenesin 600 mg

Purpose

Expectorant

Uses

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

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.

If pregnant or breat-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

■ 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
■ 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?

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

PDP

20ct

GUAIFENESIN 
guaifenesin tablet, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69848-017
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)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
Product Characteristics
ColorwhiteScoreno score
ShapeOVALSize16mm
FlavorImprint Code G;600
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69848-017-0220 in 1 BLISTER PACK; Type 0: Not a Combination Product01/06/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21342012/31/2021
Labeler - GRANULES USA, INC. (137098864)

Revised: 12/2023
Document Id: 0ccbb268-ec56-c8eb-e063-6394a90a44b4
Set id: a62d427e-f339-f225-e053-2a95a90ab387
Version: 3
Effective Time: 20231218
 
GRANULES USA, INC.