MUCUS RELIEF DM - guaifenesin and dextromethorphan hbr tablet, extended release 
Ahold U.S.A., 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 1-877-846-9949  You may also report side effects to this phone number.

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

NDC 60000-057-65
CAREOne®
MUCUS RELIEF DM
Guaifenesin 1200 mg / Dextromethorphan HBr 60 mg
Extended-Release Tablets
Expectorant/Cough Suppressant

Maximum Strength
Controls Cough
Thins and Loosens Mucus
14 EXTENDED-RELEASE TABLETS    
  
figure 1

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

NDC 60000-057-65
CARE One®
Compare to the active ingredients
in Maximum Strength Mucinex®DM*

MUCUS
RELIEF DM
Guaifenesin 1200 mg / 
Dextromethorphan HBr 60 mg
Extended-Release Tablets
Expectorant/Cough Suppresant

Maximum Strength
Controls Cough
Thins and Loosens Mucus

12h

OUR PHARMACISTS
Rx                                                        63
RECOMMENDED

14
EXTENDED-RELEASE
TABLETS


figure 2
 

MUCUS RELIEF DM 
guaifenesin and dextromethorphan hbr tablet, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60000-057
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:60000-057-651 in 1 CARTON03/17/2017
114 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20694103/17/2017
Labeler - Ahold U.S.A., Inc, (188910863)
Registrant - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIBusiness Operations
Aurobindo Pharma Limited650381903ANALYSIS(60000-057) , MANUFACTURE(60000-057)

Revised: 12/2023
Document Id: 9c159223-d3f0-48ae-9e4f-f5896838c034
Set id: 738bbea4-4243-4cbd-980e-a22451b85c4c
Version: 6
Effective Time: 20231201
 
Ahold U.S.A., Inc,