GUAIFENESIN tablet, extended release

Guaifenesin by

Drug Labeling and Warnings

Guaifenesin by is a Otc medication manufactured, distributed, or labeled by Ohm Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

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.

SPL UNCLASSIFIED SECTION

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

Principal Display Panel - Guaifenesin ER Tablets, 1200 mg

INGREDIENTS AND APPEARANCE

GUAIFENESIN 
guaifenesin tablet, extended release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51660-566
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	600 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	white (blue/white mottled)	Score	no score
Shape	OVAL	Size	16mm
Flavor		Imprint Code	RH;98
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51660-566-41	40 in 1 CARTON; Type 0: Not a Combination Product	04/01/2022
2	NDC: 51660-566-21	20 in 1 CARTON; Type 0: Not a Combination Product	04/01/2022
3	NDC: 51660-566-68	68 in 1 CARTON; Type 0: Not a Combination Product	01/17/2026

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA209254	04/01/2022

GUAIFENESIN 
guaifenesin tablet, extended release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51660-567
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	1200 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	white (blue/white mottled)	Score	no score
Shape	OVAL	Size	16mm
Flavor		Imprint Code	RH;99
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51660-567-54	14 in 1 CARTON; Type 0: Not a Combination Product	04/01/2022
2	NDC: 51660-567-86	28 in 1 CARTON; Type 0: Not a Combination Product	04/01/2022
3	NDC: 51660-567-58	56 in 1 CARTON; Type 0: Not a Combination Product	04/01/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA209254	04/01/2022

Labeler - Ohm Laboratories, Inc. (184769029)

Establishment
Name	Address	ID/FEI	Business Operations
Ohm Laboratories, Inc.		184769029	manufacture(51660-566, 51660-567) , analysis(51660-566, 51660-567) , pack(51660-566, 51660-567)

Establishment
Name	Address	ID/FEI	Business Operations
Sun Pharmaceutical Industries Limited		650456002	manufacture(51660-566, 51660-567)