GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE- guaifenesin and dextromethorphan hydrobromide tablet, extended release 
CVS PHARMACY, INC

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Guaifenesin and Dextromethorphan HBr

Drug Facts

Active ingredients (in each extended-release tablet)Purposes
Dextromethorphan HBr 60 mgCough suppressant
Guaifenesin 1200 mgExpectorant

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 (1-800-222-1222).

Directions

Other information

Inactive ingredients

carbomer homopolymer, colloidal silicon dioxide, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, povidone (K-30), stearic acid

Questions?

(1-800-406-7984)

You may also report side effects to this phone number.

Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895

PRINCIPAL DISPLAY PANEL - 70 Tablet Blister Pack Carton

VALUE SIZE

NDC 51316-600-70

CVS ®

12 HR

Maximum Strength

Mucus RELIEF DM

Guaifenesin, 1200 mg & Dextromethorphan
HBr, 60 mg

Expectorant / Cough Suppressant

Compare to Maximum

Strength Mucinex ®DM active ingredients*

Immediate & Extended Release

Controls Cough

Thins & Loosens Mucus

70 Extended-Release Tablets

cvs-GuaDM-70s

GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE 
guaifenesin and dextromethorphan hydrobromide tablet, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51316-600
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
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
POVIDONE K30 (UNII: U725QWY32X)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
Colorwhite (off-white) Scoreno score
ShapeOVALSize16mm
FlavorImprint Code 053
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51316-600-705 in 1 CARTON04/19/2022
114 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21478104/19/2022
Labeler - CVS PHARMACY, INC (062312574)
Establishment
NameAddressID/FEIBusiness Operations
Ohm Laboratories Inc.184769029manufacture(51316-600)

Revised: 4/2026
Document Id: 4fe39452-8d46-ba50-e063-6294a90ac53a
Set id: dd00dfc0-e523-4dec-8fc0-50363eadec57
Version: 5
Effective Time: 20260420
 
CVS PHARMACY, INC