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

Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bronchial 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 serious illness.

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

Directions

do not crush, chew or break extended-release tablet
take with a full glass of water
this product can be administered without regard for the timing of meals
adults and children over 12 years of age and over: one or two extended-release tablets every 12 hours. Do not exceed 4 extended-release tablets in 24 hours.
children under 12 years of age: do not use.

Other information

store between 20-25°C (68-77°F)
TAMPER EVIDENT: DO NOT USE IF CARTON IS OPEN OR IF PRINTED SEAL ON BLISTER IS BROKEN OR MISSING.

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

†Ohm® is a registered trademark of Sun Pharmaceutical Industries, Inc. All other trademarks are property of their respective owners.

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.

Package/Label Principal Display Panel

600 mg 20's

Package/Label Principal Display Panel

600mg 40's

Principal Display Panel

1200mg 14 count

Principal Display Panel

1200mg 28 count

Principal Display Panel

1200 mg 56 count
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
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: 12/2022
Document Id: 3f025732-d30a-4d58-8c34-bc79e1f33a21
Set id: 7076e42a-17ff-4c42-9963-2dc02c0a5e49
Version: 2
Effective Time: 20221215
 
Ohm Laboratories, Inc.