GUAIFENESIN tablet, extended release

GUAIFENESIN by

Drug Labeling and Warnings

GUAIFENESIN by is a Otc medication manufactured, distributed, or labeled by Advanced Rx LLC, Ganules India Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients ​(in each extended-release bi-layer tablet)

Guaifenesin  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  (1-800-222-1222) right away.

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 tablet every 12 hours. Do not exceed 2 tablets in 24 hours. 
• children under 12 years of age:do not use

Other information

• store between 20-25°C (68-77°F).
• DO NOT USE IF PRINTED SEAL UNDER CAP IS MISSING OR DAMAGED.

Inactive ingredients

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

Questions?

call toll-free 1-800-630-8895

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

GUAIFENESIN 
guaifenesin tablet, extended release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80513-413
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, UNSPECIFIED (UNII: 3NXW29V3WO)
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)
SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)

Product Characteristics
Color	white	Score	no score
Shape	OVAL	Size	21mm
Flavor		Imprint Code	G;1200
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80513-413-11	110 in 1 BOTTLE; Type 0: Not a Combination Product	07/01/2025

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

Labeler - Advanced Rx LLC (042795108)

Establishment
Name	Address	ID/FEI	Business Operations
Ganules India Limited		918609236	manufacture(80513-413)