GUAIFENESIN AND DEXTROMETHORPHAN HBR- guaifenesin and dextromethorphan hbr tablet, extended release 
CVS Pharmacy

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Drug Facts

Active ingredients

(in each extended-release tablet)

Guaifenesin USP, 600 mg

Dextromethorphan Hydrobromide USP, 30 mg

Purposes

Expectorant

Cough suppressant

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

For 600 mg/30 mg:

Other information

Inactive ingredients

carbomer homopolymer type B, colloidal silicon dioxide, FD & C Blue #1, ferric oxide yellow, hypromellose, magnesium stearate, microcrystalline cellulose and sodium starch glycolate.

Questions

call 1-888-375-3784 Weekdays (9am - 8pm EST)

You may also report side effects to this phone number.

PACKAGE LABEL PRINCIPAL DISPLAY PANEL SECTION

carton

GUAIFENESIN AND DEXTROMETHORPHAN HBR 
guaifenesin and dextromethorphan hbr tablet, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51316-009
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
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
HYPROMELLOSE 2910 (10000 MPA.S) (UNII: 0HO1H52958)  
HYPROMELLOSE 2208 (4000 MPA.S) (UNII: 39J80LT57T)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)  
Product Characteristics
ColorWHITE (white to off white) , GREEN (light green to green) Scoreno score
ShapeOVALSize16mm
FlavorImprint Code 3
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51316-009-015 in 1 CARTON08/15/2023
120 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21734008/15/2023
Labeler - CVS Pharmacy (062312574)

Revised: 8/2023
Document Id: 60b6b5aa-5005-db80-feb2-39c187ae0e0c
Set id: 7942eeae-0528-4416-bd2f-b05acc71c0a9
Version: 3
Effective Time: 20230801
 
CVS Pharmacy