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

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Maximum Strength
Guaifenesin Extended-Release Tablets 1200 mg
Expectorant
• Relieves Chest Congestion
• Thins and Loosens Mucus
• Immediate and Extended Release

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

Guaifenesin 1200 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 a 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 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

 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 tablet every 12 hours. Do not exceed 2 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, hypromellose, magnesium stearate, microcrystalline cellulose, sodium starch glycolate

Questions?

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

Principal display panel

14ct

GUAIFENESIN 
guaifenesin tablet, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69848-018
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN1200 mg
Inactive Ingredients
Ingredient NameStrength
SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4)  
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) (UNII: Z135WT9208)  
Product Characteristics
ColorwhiteScoreno score
ShapeOVALSize22mm
FlavorImprint Code G;1200
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69848-018-1614 in 1 BLISTER PACK; Type 0: Not a Combination Product09/12/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21342009/12/2024
Labeler - GRANULES USA, INC. (137098864)

Revised: 12/2025
Document Id: 469099a1-3de3-d107-e063-6294a90adf16
Set id: a62e2045-8ec2-1771-e053-2995a90a03b4
Version: 7
Effective Time: 20251222
 
GRANULES USA, INC.