GUAIFENESIN- guaifenesin tablet, extended release 
AMERISOURCE BERGEN

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Guaifenesin

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.

Questions?

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

Distributed By:
AmerisourceBergen
1 West First Avenue
Conshohocken, PA 19428

PRINCIPAL DISPLAY PANEL - 600 mg Tablet Blister Pack Carton

NDC 46122-750-51

Compare to
active ingredient in
Mucinex® †

GOOD
NEIGHBOR
PHARMACY®

12 HOUR

Mucus • ER
Guaifenesin Extended-Release
Tablets, 600 mg

Expectorant

20 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:46122-750
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 (UNII: L06K8R7DQK)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
Product Characteristics
ColorWHITE (blue/white mottled) Scoreno score
ShapeOVALSize16mm
FlavorImprint Code RH98
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:46122-750-512 in 1 CARTON08/11/2023
110 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20925408/11/2023
Labeler - AMERISOURCE BERGEN (007914906)
Establishment
NameAddressID/FEIBusiness Operations
Sun Pharmaceutical Industries Limited650456002MANUFACTURE(46122-750)

Revised: 9/2023
Document Id: 61d84e6e-eae0-4ee6-87c4-5c0ab15bc38d
Set id: d1d94d37-4423-4914-9d86-c5ca6d5122f6
Version: 2
Effective Time: 20230925
 
AMERISOURCE BERGEN