GUAIFENESIN EXTENDED-RELEASE TABLETS, 600MG- guaifenesin extended-release tablet GUAIFENSIN EXTENDED-RELEASE TABLETS, 1200 MG- guaifensin extended-release tablet

Guaifensin Extended-Release Tablets, 1200 mg by

Drug Labeling and Warnings

Guaifensin Extended-Release Tablets, 1200 mg by is a Otc medication manufactured, distributed, or labeled by Granules India Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT(S)

Guaifenesin 600 mg (for 600mg)
 
Guaifenesin 1200 mg (for 1200 mg)

PURPOSE

Expectorant

USE(S)

• helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome 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 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.

PREGNANCY/BREASTFEEDING

ask a health professional before use.

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)

DIRECTIONS

• do not crush, chew, or break tablet
• take with a full glass of water
• this product can be administered without regard for timing of meals
• adults and children 12 years of age and over: 1 or 2 tablets every 12 hours. Do not exceed 4 tablets in 24 hours(For 600mg)
• adults and children 12 years of age and over: 1 tablet every 12 hours. Do not exceed 2 tablets in 24 hours.(For 1200mg)
• children under 12 years of age: do not use

OTHER INFORMATION

 Tamper evident: Do not use if carton is open or if printed seal on blister is broken or missing.

INACTIVE INGREDIENTS

carbomer homopolymer type B; hypromellose, Lake of FD&C Blue 1, magnesium stearate, microcrystalline cellulose; sodium starch glycolate

QUESTIONS OR COMMENTS

Contact 1-877-770-3183 Mon-Fri 8:00 AM EST to 5:00 PM PST.

All trademarks are property of their respective owners.MUCINEX is the registered trademark of Reckitt Benckiser LLC.

STORAGE

store between 20-25°C (68-77°F)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

GUAIFENESIN EXTENDED-RELEASE TABLETS, 600MG 
guaifenesin extended-release tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62207-697
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
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)

Product Characteristics
Color	blue (white and blue)	Score	no score
Shape	OVAL	Size	16mm
Flavor		Imprint Code	G;600
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62207-697-72	9 in 1 CARTON	09/10/2020
1		10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA213420	09/10/2020

GUAIFENSIN EXTENDED-RELEASE TABLETS, 1200 MG 
guaifensin extended-release tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62207-698
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
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)

Product Characteristics
Color	blue (white-blue)	Score	no score
Shape	OVAL	Size	22mm
Flavor		Imprint Code	G;1200
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62207-698-71	7 in 1 CARTON	09/10/2020
1		10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA213420	09/10/2020

Labeler - Granules India Ltd (915000087)

Establishment
Name	Address	ID/FEI	Business Operations
Granules India Ltd		918609236	manufacture(62207-697, 62207-698) , analysis(62207-697, 62207-698) , pack(62207-697, 62207-698) , label(62207-697, 62207-698)