GUAIFENESIN 600 MG - guaifenesin 600 mg tablet 
GUAIFENESIN 1200 MG - guaifenesin 1200 mg tablet 
MARKSANS PHARMA LIMITED

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Guaifenesin Extended-Release Tablets 600 mg and 1200 mg

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

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


guaifenesin-600mg-blister-ifc20s


NDC: 25000-042-01

Guaifenesin Extended-Release Tablets 600 mg

20's count Bottle Label


guaifenesin-600mg-bottle-label-20s


NDC: 25000-042-01

Guaifenesin Extended-Release Tablets 600 mg

20's count Bottle Carton


guaifenesin-600mg-bottle-ifc-20s


NDC: 25000-042-12

Guaifenesin Extended-Release Tablets 600 mg

500's count Bottle Label


guaifenesin-600mg-bottle-label-500s


NDC: 25000-041-75

Guaifenesin Extended-Release Tablets 1200 mg

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


guaifenesin-1200mg-blister-ifc-12s


NDC: 25000-041-12

Guaifenesin Extended-Release Tablets 1200 mg

500's count Bottle Label


guaifenesin-1200mg-bottle-label-500s



GUAIFENESIN 600 MG 
guaifenesin 600 mg tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:25000-042
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)  
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
ColorWHITE (Blue and White) Scoreno score
ShapeOVALSize16mm
FlavorImprint Code 42
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:25000-042-552 in 1 CARTON08/23/2023
110 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:25000-042-011 in 1 CARTON08/23/2023
220 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:25000-042-12500 in 1 BOTTLE; Type 0: Not a Combination Product08/23/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21778008/23/2023
GUAIFENESIN 1200 MG 
guaifenesin 1200 mg tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:25000-041
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)  
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
ColorWHITE (Blue and White) Scoreno score
ShapeCAPSULESize22mm
FlavorImprint Code 41
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:25000-041-752 in 1 CARTON08/23/2023
16 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:25000-041-12500 in 1 BOTTLE; Type 0: Not a Combination Product08/23/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21778008/23/2023
Labeler - MARKSANS PHARMA LIMITED (925822975)
Establishment
NameAddressID/FEIBusiness Operations
MARKSANS PHARMA LIMITED925822975MANUFACTURE(25000-041, 25000-042)

Revised: 8/2023
Document Id: c7abd113-e773-4217-aa2c-86a31916aa0a
Set id: fedf43d0-d6d1-4f50-bbab-396701e45cb2
Version: 3
Effective Time: 20230828
 
MARKSANS PHARMA LIMITED