GUAIFENESIN- guaifenesin tablet, extended release 
Ohm Laboratories, Inc.

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Drug Facts

Active ingredient

(in each extended-release tablet)

Guaifenesin, USP

Purpose

Expectorant

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).

Uses

Warnings

Do not use

Ask a doctor before use if you have

Stop use and ask a doctor if

If pregnant or breast-feeding,ask a health professional before use.

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.

Keep the carton. It contains important information. See end panel for expiration date.

†OHM and OHM Logo are trademarks of Ohm Laboratories, Inc. All other trademarks are the property of their respective owners.

Distributed by:
Ohm Laboratories Inc.
New Brunswick, NJ 08901


PRODUCT OF INDIA


R0425

CODE No.: PB/DRUGS/1809-0SP

Package/Label Principal Display Panel - Guaifenesin ER Tablets, 600 mg

spl-guaifenesin-ohm

Principal Display Panel - Guaifenesin ER Tablets, 1200 mg

spl-guaifenesin-ohm2

GUAIFENESIN 
guaifenesin tablet, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51660-566
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 RH;98
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51660-566-4140 in 1 CARTON; Type 0: Not a Combination Product04/01/2022
2NDC:51660-566-2120 in 1 CARTON; Type 0: Not a Combination Product04/01/2022
3NDC:51660-566-6868 in 1 CARTON; Type 0: Not a Combination Product01/17/2026
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20925404/01/2022
GUAIFENESIN 
guaifenesin tablet, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51660-567
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN1200 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 RH;99
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51660-567-5414 in 1 CARTON; Type 0: Not a Combination Product04/01/2022
2NDC:51660-567-8628 in 1 CARTON; Type 0: Not a Combination Product04/01/2022
3NDC:51660-567-5856 in 1 CARTON; Type 0: Not a Combination Product04/01/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20925404/01/2022
Labeler - Ohm Laboratories, Inc. (184769029)
Establishment
NameAddressID/FEIBusiness Operations
Ohm Laboratories, Inc.184769029manufacture(51660-566, 51660-567) , analysis(51660-566, 51660-567) , pack(51660-566, 51660-567)
Establishment
NameAddressID/FEIBusiness Operations
Sun Pharmaceutical Industries Limited650456002manufacture(51660-566, 51660-567)

Revised: 2/2026
Document Id: 4aa4fb35-6f33-6e33-e063-6394a90a495e
Set id: 7076e42a-17ff-4c42-9963-2dc02c0a5e49
Version: 4
Effective Time: 20260212
 
Ohm Laboratories, Inc.