GUAIFENESIN- guaifenesin tablet, extended release 
Publix Super Markets, Inc

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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

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.

DISTRIBUTED BY PUBLIX SUPER MARKETS, INC.,
3300 PUBLIX CORPORATE PARKWAY
LAKELAND, FL 33811

PRINCIPAL DISPLAY PANEL - 20 extended-release Tablets Blister Pack Carton

NDC 41415-996-20

12-HOUR
mucus relief

GUAIFENESIN EXTENDED-RELEASE
TABLETS, 600 mg

EXPECTORANT

12 Hour

20
EXTENDED-RELEASE
TABLETS

†Compare to the active
ingredient of Mucinex®

PRINCIPAL DISPLAY PANEL - 20 extended-release Tablets Blister Pack Carton
GUAIFENESIN 
guaifenesin tablet, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41415-996
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ) Guaifenesin600 mg
Inactive Ingredients
Ingredient NameStrength
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
Product Characteristics
ColorWHITEScoreno score
ShapeOVALSize16mm
FlavorImprint Code RH98
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41415-996-201 in 1 CARTON02/08/2018
120 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20925401/08/2018
Labeler - Publix Super Markets, Inc (006922009)
Establishment
NameAddressID/FEIBusiness Operations
Ohm Laboratories Inc.184769029MANUFACTURE(41415-996)

Revised: 2/2022
Document Id: 1ec2b7b7-830a-4e04-b738-baed27b47662
Set id: 435e627c-b4f4-4214-904a-7527aab32cbf
Version: 1
Effective Time: 20220204
 
Publix Super Markets, Inc