GUAIFENESIN EXTENDED RELEASE- guaifenesin tablet, extended release

Guaifenesin Extended Release by

Drug Labeling and Warnings

Guaifenesin Extended Release by is a Otc medication manufactured, distributed, or labeled by Perrigo New York Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each extended-release 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 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 the 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 foil under cap is broken or missing

Inactive ingredients

colloidal silicon dioxide, copovidone, FD&C blue #1 aluminum lake, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, povidone, sodium starch glycolate Type A, stearic acid

Questions or comments?

1-800-719-9260

Package/Label Principal Display Panel

Compare to Maximum Strength Mucinex® active ingredient

Maximum Strength

Guaifenesin Extended-Release Tablets, 1200 mg

Expectorant

12 Hour

Relieves Chest Congestion

Thins and Loosens Mucus

Actual Size

14 Extended-Release Tablets

INGREDIENTS AND APPEARANCE

GUAIFENESIN EXTENDED RELEASE 
guaifenesin tablet, extended release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 45802-325
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
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
COPOVIDONE K25-31 (UNII: D9C330MD8B)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
STEARIC ACID (UNII: 4ELV7Z65AP)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Product Characteristics
Color	BLUE (Light Blue)	Score	no score
Shape	OVAL (Biconvex)	Size	22mm
Flavor		Imprint Code	Watson;1200
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 45802-325-30	1 in 1 CARTON	01/25/2016
1		28 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 45802-325-66	1 in 1 CARTON	03/16/2016
2		14 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA091009	01/25/2016

Labeler - Perrigo New York Inc (078846912)