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

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Maximum Strength
Guaifenesin Extended-Release Tablets 1200mg
Expectorant
Relievers Chest Congestion
This and Loosems Mucus
Immediate and Extended Releas e
12 Hour

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

Stop use and ask a doctor if

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

Other information

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.

Maximum Strength Guaifenesin Extended-Release Tablets 1200mg

14 count

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
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) (UNII: Z135WT9208)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4)  
SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
Product Characteristics
ColorwhiteScoreno score
ShapeOVAL (elliptical shaped, biconvex tablet) Size22mm
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 Product02/21/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21342002/21/2021
Labeler - GRANULES USA, INC. (137098864)

Revised: 1/2024
Document Id: 0dfd5775-138b-c205-e063-6394a90a2022
Set id: a62e2045-8ec2-1771-e053-2995a90a03b4
Version: 3
Effective Time: 20240102
 
GRANULES USA, INC.