GUAIFENESIN- guaifenesin tablet, extended release 
Safrel Pharmaceuticals, LLC.

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Guaifenesin Extended-Release Tablets 1200mg

ACTIVE INGREDIENT(S)

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

INACTIVE INGREDIENTS

carbomer homopolymer type B; hypromellos, magnesium stearate,  microcrystalline cellulose, sodium starch glycolate

QUESTIONS OR COMMENTS

Contact 1-844-384-3723

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 1200 mg

GUAIFENESIN 
guaifenesin tablet, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71309-461
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:71309-461-5656 in 1 BOTTLE; Type 0: Not a Combination Product06/29/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21342012/18/2020
Labeler - Safrel Pharmaceuticals, LLC. (080566287)

Revised: 3/2023
Document Id: f7f18eb7-a4bc-b7f6-e053-6394a90a0f74
Set id: e2a3d6cb-5251-b88e-e053-2a95a90a9e30
Version: 2
Effective Time: 20230328
 
Safrel Pharmaceuticals, LLC.