MAXIMUM STRENGTH COUGH AND CONGESTION EXTENDED RELEASE - guaifenesin and dextromethorphan hbr tablet, extended release 
CVS Pharmacy, Inc.

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Drug Facts

Active Ingredients

(in each extended-release tablet)

Dextromethorphan Hydrobromide USP 60 mg
Guaifenesin USP 1200 mg

Purpose

Cough suppressant
Expectorant

Uses


Warnings

Do not use


Ask a doctor before use if you have


When using this product


Stop use and ask a doctor if


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 (1-800-222-1222) right away.

Directions


Other information


Inactive ingredients


colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch (maize)

Questions?


call 1-855-274-4122 You may also report side effects to this phone number. 

Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
©2024 CVS/Pharmacy
CVS.Com® 1-800-SHOP CVS
Made in India
V-32402


PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1200 mg/60 mg (14 Tablet Carton Label)

CVS Health®

NDC 51316-060-65

MAXIMUM STRENGTH

COUGH &
CONGESTION

GUAIFENESIN, 1200 mg
DEXTROMETHORPHAN HBr, 60 mg
Expectorant / Cough Suppressant

EXTENDED-RELEASE

Controls cough

Thins & loosens mucus

12
HOUR

Compare to the active ingredients
in Maximum Strength Mucinex® DM*

14 TABLETS           
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1200 mg/60 mg (14 Tablet Carton Label)

MAXIMUM STRENGTH COUGH AND CONGESTION EXTENDED RELEASE 
guaifenesin and dextromethorphan hbr tablet, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51316-060
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN1200 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE60 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POVIDONE K90 (UNII: RDH86HJV5Z)  
POVIDONE K25 (UNII: K0KQV10C35)  
STARCH, CORN (UNII: O8232NY3SJ)  
Product Characteristics
ColorWHITE (white to off-white) Scoreno score
ShapeOVALSize22mm
FlavorImprint Code X;63
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51316-060-652 in 1 CARTON04/01/2024
17 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20694104/01/2024
Labeler - CVS Pharmacy, Inc. (062312574)
Registrant - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIBusiness Operations
Aurobindo Pharma Limited650381903ANALYSIS(51316-060) , MANUFACTURE(51316-060)

Revised: 6/2024
Document Id: 40d85fdb-34e7-4c48-ae27-cb2f7eb33543
Set id: 13ee8bb1-9525-a5bc-e063-6294a90a9db9
Version: 3
Effective Time: 20240627
 
CVS Pharmacy, Inc.