GUAIFENESIN EXTENDED RELEASE 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 NCS HealthCare of KY, Inc dba Vangard Labs. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each extended-release tablet)

Guaifenesin 600 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: one or two tablets every 12 hours. Do not exceed 4 tablets in 24 hours.
• children under 12 years of age: do not use

Other information

• do not use if printed seal under cap is broken or missing
• store between 20-25°C (68-77°F)

Inactive ingredients

compressible sugar, copovidone, hydroxyethyl cellulose, silicon dioxide, zinc stearate

Questions or comments?

1-800-719-9260

Distributed by Perrigo®

Allegan, MI 49010

www.perrigo.com

49878 RT F3

Package/Label Principal Display Panel

INGREDIENTS AND APPEARANCE

GUAIFENESIN EXTENDED RELEASE  EXTENDED RELEASE
guaifenesin tablet, extended release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0615-7712(NDC: 45802-498)
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
COPOVIDONE K25-31 (UNII: D9C330MD8B)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ZINC STEARATE (UNII: H92E6QA4FV)
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP)

Product Characteristics
Color	WHITE ((off-white))	Score	no score
Shape	ROUND	Size	12mm
Flavor		Imprint Code	L498
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0615-7712-39	30 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	ANDA078912	03/28/2012

Labeler - NCS HealthCare of KY, Inc dba Vangard Labs (050052943)

Establishment
Name	Address	ID/FEI	Business Operations
NCS HealthCare of KY, Inc dba Vangard Labs		050052943	REPACK(0615-7712)