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 30 mg
Guaifenesin USP 600 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 - 600 mg/30 mg (20 Tablet Bottle)

NDC 60000-058-67
MUCUS RELIEF DM
Guaifenesin 600 mg / Dextromethorphan HBr 30 mg
Extended-Release Tablets
Expectorant/Cough Suppressant

Controls Cough
Thins and Loosens Mucus
20 EXTENDED-RELEASE TABLETS

figure 1

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 600 mg/30 mg (20 Tablet Carton Label)

NDC 60000-058-67
CARE ONE®
compare to the active ingredient in
Mucinex® DM*

MUCUS
RELIEF DM
Guaifenesin 600 mg/
Dextromethorphan HBr 30 mg
Extended-Release Tablets
Expectorant/Cough Suppressant
Controls Cough
Thins and Loosens Mucus

20
EXTENDED RELEASE
TABLETS

figure 2

MUCUS RELIEF DM 
guaifenesin and dextromethorphan hbr tablet, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60000-058
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN600 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE30 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
ShapeOVALSize16mm
FlavorImprint Code X;62
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:60000-058-671 in 1 CARTON03/17/2017
120 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(60000-058) , MANUFACTURE(60000-058)

Revised: 12/2023
Document Id: bab0bd5d-74e4-48cb-9990-6f5944c3d3dc
Set id: e9add770-58e0-4cf3-bbc2-d293ca870b03
Version: 5
Effective Time: 20231201
 
Ahold U.S.A., Inc,