GUAIFENESIN EXTENDED RELEASE- guaifenesin tablet, extended release 
PUBLIX SUPER MARKETS, INC

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GUAIFENESIN EXTENDED-RELEASE TABLETS

Drug Facts

Active ingredient (in each extended-release tablet)

Guaifenesin, USP 1200 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.

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

PRINCIPAL DISPLAY PANEL - 1200 mg Extended-Release Tablet Blister Pack Carton

NDC 41415-997-14

12-HOUR MAXIMUM STRENGTH
mucusrelief
GUAIFENESIN EXTENDED-RELEASE
TABLETS, 1200 mg
EXPECTORANT

12 Hour

14
EXTENDED-RELEASE
TABLETS

†Compare to the active
ingredient of Mucinex®
Maximum Strength

PRINCIPAL DISPLAY PANEL - 1200 mg Extended-Release Tablet Blister Pack Carton
GUAIFENESIN  EXTENDED RELEASE
guaifenesin tablet, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41415-997
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ) Guaifenesin1200 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
ShapeOVALSize22mm
FlavorImprint Code RH99
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41415-997-141 in 1 CARTON12/10/2017
114 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20925412/10/2017
Labeler - PUBLIX SUPER MARKETS, INC (006922009)
Establishment
NameAddressID/FEIBusiness Operations
Ohm Laboratories Inc.184769029MANUFACTURE(41415-997)

Revised: 2/2022
Document Id: 36b48471-5ae5-4b36-82c9-62fa4f3602c6
Set id: 038e1801-b978-4a2e-ae8c-8803596ec09c
Version: 1
Effective Time: 20220209
 
PUBLIX SUPER MARKETS, INC