GUAIFENESIN tablet, extended release

GUAIFENESIN by

Drug Labeling and Warnings

GUAIFENESIN by is a Otc medication manufactured, distributed, or labeled by Granules India Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients ​(in each extended-release tablet)

Guaifenesin 600 mg (for 600 mg)

Guaifenesin 1200 mg (for 1200 mg)

purpose

Expectorant

Uses

• 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 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.

If pregnant or breast-feeding,

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 extended-release 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 extended-release tablets every 12 hours. Do not exceed 4 extended-release tablets in 24 hours (For 600 mg)
• 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. (For 1200 mg)
• 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.
• store between 20-25°C (68-77°F)

Inactive ingredients

carbomer homopolymer type B; hypromellose; magnesium stearate; microcrystalline cellulose; sodium starch glycolate

Questions?

Contact 1-877-770-3183

Mon-Fri 8:00 AM EST to 5:00 PM PST.

PRINCIPAL DISPLAY PANEL - 600 mg Blister Carton Label

NDC 62207- 839-72 Compare to the active ingredient
of Mucinex ®

Guaifenesin
Extended-Release Tablets 600 mg

Guaifenesin 600 mg - Expectorant

RELIEVES CHEST CONGESTION

12HR FOR DAY Relieves Chest Congestion
OR NIGHT Thins and Loosens Mucus
Immediate and Extended Release

90 (9 x 10) EXTENDED-RELEASE TABLETS

PRINCIPAL DISPLAY PANEL - 1200 mg Blister Carton Label

NDC 62207- 840-71 Compare to the active ingredient
of Mucinex®

Guaifenesin
Extended-Release Tablets 1200 mg

Maximum strength

Guaifenesin 1200 mg - Expectorant

RELIEVES CHEST CONGESTION

12HR FOR DAY Relieves Chest Congestion
OR NIGHT Thins and Loosens Mucus
Immediate and Extended Release

70 (7 x 10) EXTENDED-RELEASE TABLETS

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

GUAIFENESIN 
guaifenesin tablet, extended release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62207-839
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 TYPE B (ALLYL SUCROSE CROSSLINKED) (UNII: Z135WT9208)
HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
HYPROMELLOSE 2910 (10000 MPA.S) (UNII: 0HO1H52958)

Product Characteristics
Color	white	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: 62207-839-72	9 in 1 CARTON	12/18/2020
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	12/18/2020

GUAIFENESIN 
guaifenesin tablet, extended release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62207-840
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
HYPROMELLOSE 2910 (10000 MPA.S) (UNII: 0HO1H52958)
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) (UNII: Z135WT9208)
HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62207-840-71	7 in 1 CARTON	12/18/2020
1		10 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 62207-840-99	4200 in 1 BAG; Type 0: Not a Combination Product	12/18/2020
3	NDC: 62207-840-93	10000 in 1 BOX; Type 0: Not a Combination Product	10/31/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA213420	12/18/2020

Labeler - Granules India Ltd (915000087)

Establishment
Name	Address	ID/FEI	Business Operations
Ganules India Limited		918609236	analysis(62207-839, 62207-840) , label(62207-839, 62207-840) , manufacture(62207-839, 62207-840) , pack(62207-839, 62207-840)