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

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Guaifenesin Extended-Release Tablets 600mg and 1200mg

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

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

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

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:62207-697-72	9 in 1 CARTON	09/10/2020	06/30/2021
1		10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA213420	09/10/2020	06/30/2021

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

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

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:62207-698-71	7 in 1 CARTON	09/10/2020	06/30/2021
1		10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA213420	09/10/2020	06/30/2021

Labeler - Granules India Ltd (915000087)

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

Revised: 8/2024

Document Id: 1fca8483-6bd0-a5c4-e063-6394a90a61ed

Set id: cea4dba6-9839-40a1-a328-f7c6aeb69d0c

Version: 3

Effective Time: 20240816

Granules India Ltd