GUAIFENESIN- guaifenesin tablet, extended release 
CVS

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GUAIFENESIN EXTENDED-RELEASE TABLETS, 600 mg

Drug Facts

Active ingredient (in each extended-release tablet)

Guaifenesin, USP 600 mg

Purpose

Expectorant

Uses

helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

Warnings

Do not use

  • for children under 12 years of age

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)

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

colloidal silicon dioxide, FD&C blue #2 aluminum lake, hypromellose, magnesium stearate, povidone.

Questions?

call toll-free Monday to Friday 8:30 am to 5:00 pm EST at 1-800-406-7984.

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

PRINCIPAL DISPLAY PANEL - 600 mg Tablet Blister Pack Carton

CVS
Health®

Compare to the active
ingredient in Mucinex®*

NDC 51316-071-68

Mucus
Extended
Release

12
HOUR

GUAIFENESIN EXTENDED-RELEASE
TABLETS, 600 mg

EXPECTORANT

Actual Size

68 EXTENDED-
RELEASE TABLETS

Principal Display Panel - 600 mg Tablet Blister Pack Carton
GUAIFENESIN 
guaifenesin tablet, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51316-071
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ) Guaifenesin600 mg
Inactive Ingredients
Ingredient NameStrength
silicon dioxide (UNII: ETJ7Z6XBU4)  
FD&C blue no. 2--aluminum lake (UNII: 4AQJ3LG584)  
hypromellose, unspecified (UNII: 3NXW29V3WO)  
magnesium stearate (UNII: 70097M6I30)  
povidone, unspecified (UNII: FZ989GH94E)  
Product Characteristics
ColorBLUE, WHITEScoreno score
ShapeOVAL (biconvex) Size16mm
FlavorImprint Code RH98
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51316-071-681 in 1 CARTON10/07/2022
168 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20925410/07/2022
Labeler - CVS (062312574)
Establishment
NameAddressID/FEIBusiness Operations
Ohm Laboratories Inc.184769029MANUFACTURE(51316-071)

Revised: 11/2022
Document Id: c84bf7a4-0567-4d1c-bcaa-976de2a31ff4
Set id: 4efa8bf9-3394-47b4-b630-9476b15d2dfc
Version: 2
Effective Time: 20221123
 
CVS