MUCINEX DM- dextromethorphan hydrobromide, guaifenesin tablet, extended release 
Navajo Manufacturing Company Inc.

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Mucinex DM

Drug Facts

Active ingredients (in each extended-release bi-layer tablet)

Dextromethorphan HBr 30 mg

Guaifenesin 600 mg

Purposes

Cough suppressant

Expectorant

Uses

Warnings

Do not use

  • for children under 12 years of age
  • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • cough accompanied by too much phlegm (mucus)

When using this product

  • do not use more than directed

Stop use and ask a doctor if

  • cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. 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.

Directions

Other information

Inactive ingredients

carbomer homopolymer type B; D&C yellow #10 aluminum lake; hypromellose, USP; magnesium stearate, NF; microcrystalline cellulose, NF; sodium starch glycolate, NF

Questions?

1-866-MUCINEX (1-866-682-4639) You may also report side effects to this phone number.

Package Labeling:

Mucinex

MUCINEX DM 
dextromethorphan hydrobromide, guaifenesin tablet, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67751-171(NDC:63824-056)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE30 mg
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN600 mg
Inactive Ingredients
Ingredient NameStrength
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL OR ALLYL SUCROSE CROSSLINKED) (UNII: K6MOM3T5YL)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
Product Characteristics
Colorwhite (yellow and white) Scoreno score
ShapeOVALSize16mm
FlavorImprint Code Mucinex;600
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67751-171-011 in 1 CARTON09/23/2016
12 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02162009/23/2016
Labeler - Navajo Manufacturing Company Inc. (091917799)
Establishment
NameAddressID/FEIBusiness Operations
Navajo Manufacturing Company Inc.136941411relabel(67751-171)

Revised: 3/2023
Document Id: f70e0eb0-95aa-645c-e053-6394a90aae83
Set id: 4226f394-f85e-45b1-8d5f-7cffb7dd492f
Version: 4
Effective Time: 20230316
 
Navajo Manufacturing Company Inc.