GUAIFENESIN 600 MG tablet GUAIFENESIN 1200 MG tablet

Guaifenesin 1200 mg by

Drug Labeling and Warnings

Guaifenesin 1200 mg by is a Otc medication manufactured, distributed, or labeled by MARKSANS PHARMA LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

OTC - ACTIVE INGREDIENT SECTION

For 600 mg:           
Active ingredient (in each extended-release tablet)

Guaifenesin, USP 600 mg

For 1200 mg:
Active ingredient (in each extended-release tablet)

Guaifenesin, USP 1200 mg

OTC - PURPOSE SECTION

Purpose

Expectorant

INDICATIONS & USAGE SECTION

Uses

 helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

WARNINGS SECTION

OTC - DO NOT USE SECTION

Do not use

 for children under 12 years of age

OTC - ASK DOCTOR SECTION

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)

OTC - STOP USE SECTION

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.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

DOSAGE & ADMINISTRATION SECTION

Directions

For 600 mg

 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 12 years of age and over: 1 or 2 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

For 1200 mg

 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 12 years of age and over: 1 extended - release tablet every 12 hours. Do not exceed 2 extended - release tablets in 24 hours.
 children under 12 years of age: do not use

STORAGE AND HANDLING SECTION

Other information

 store at 20-25°C (68-77°F)

INACTIVE INGREDIENT SECTION

Inactive ingredients colloidal silicon dioxide, copovidone, FD&C Blue No. 1 Aluminum lake, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, povidone (K-30), sodium starch glycolate, stearic acid

OTC - QUESTIONS SECTION

Questions or comments?

Call 1-877-376-4271 (weekdays 9 AM to 5 PM)
You may also report side effects to this phone number.

Manufactured for:
Time-Cap Labs, Inc.
7 Michael Avenue,
Farmingdale,
NY 11735, USA

Manufactured by:
Marksans Pharma Ltd.
Plot No. L-82, L-83
Verna Indl. Estate
Verna, Goa-403722, India 

PRINCIPAL DISPLAY PANEL

NDC: 25000-042-55

Guaifenesin Extended-Release Tablets 600 mg

20's count (2 x 10's blister) Carton

NDC: 25000-042-01

Guaifenesin Extended-Release Tablets 600 mg

20's count Bottle Label

NDC: 25000-042-01

Guaifenesin Extended-Release Tablets 600 mg

20's count Bottle Carton

NDC: 25000-042-12

Guaifenesin Extended-Release Tablets 600 mg

500's count Bottle Label

NDC: 25000-041-75

Guaifenesin Extended-Release Tablets 1200 mg

12's count (2 x 6's blister) Carton

NDC: 25000-041-12

Guaifenesin Extended-Release Tablets 1200 mg

500's count Bottle Label

INGREDIENTS AND APPEARANCE

GUAIFENESIN 600 MG 
guaifenesin 600 mg tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 25000-042
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)
COPOVIDONE K25-31 (UNII: D9C330MD8B)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
MICROCRYSTALLINE CELLULOSE 102 (UNII: PNR0YF693Y)
POVIDONE K30 (UNII: U725QWY32X)
SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)
STEARIC ACID (UNII: 4ELV7Z65AP)
FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)

Product Characteristics
Color	WHITE (Blue and White)	Score	no score
Shape	OVAL	Size	16mm
Flavor		Imprint Code	42
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 25000-042-55	2 in 1 CARTON	08/23/2023
1		10 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 25000-042-01	1 in 1 CARTON	08/23/2023
2		20 in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 25000-042-12	500 in 1 BOTTLE; Type 0: Not a Combination Product	08/23/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA217780	08/23/2023

GUAIFENESIN 1200 MG 
guaifenesin 1200 mg tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 25000-041
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)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
MICROCRYSTALLINE CELLULOSE 102 (UNII: PNR0YF693Y)
POVIDONE K30 (UNII: U725QWY32X)
SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)
STEARIC ACID (UNII: 4ELV7Z65AP)
FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)
COPOVIDONE K25-31 (UNII: D9C330MD8B)

Product Characteristics
Color	WHITE (Blue and White)	Score	no score
Shape	CAPSULE	Size	22mm
Flavor		Imprint Code	41
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 25000-041-75	2 in 1 CARTON	08/23/2023
1		6 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 25000-041-12	500 in 1 BOTTLE; Type 0: Not a Combination Product	08/23/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA217780	08/23/2023

Labeler - MARKSANS PHARMA LIMITED (925822975)

Establishment
Name	Address	ID/FEI	Business Operations
MARKSANS PHARMA LIMITED		925822975	MANUFACTURE(25000-041, 25000-042)