GUAIFENESIN EXTENDED RELEASE EXTENDED RELEASE- guaifenesin tablet, extended release 
NCS HealthCare of KY, LLC dba Vangard Labs

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Guaifenesin ER Tabs

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

Guaifenesin ER Tablets 600mg
GUAIFENESIN EXTENDED RELEASE  EXTENDED RELEASE
guaifenesin tablet, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0615-7712(NDC:45802-498)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN600 mg
Inactive Ingredients
Ingredient NameStrength
COPOVIDONE K25-31 (UNII: D9C330MD8B)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
ZINC STEARATE (UNII: H92E6QA4FV)  
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP)  
Product Characteristics
Colorwhite ((off-white)) Scoreno score
ShapeROUNDSize12mm
FlavorImprint Code L498
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0615-7712-3930 in 1 BLISTER PACK; Type 0: Not a Combination Product06/23/201512/31/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07891203/28/201212/31/2017
Labeler - NCS HealthCare of KY, LLC dba Vangard Labs (050052943)
Establishment
NameAddressID/FEIBusiness Operations
NCS HealthCare of KY, LLC dba Vangard Labs050052943repack(0615-7712)

Revised: 7/2015
Document Id: eb5d16e4-5d1f-43f6-aae7-128f0f142c95
Set id: f3f7802e-ee96-4462-a7e6-bb087d0fdcf5
Version: 2
Effective Time: 20150706
 
NCS HealthCare of KY, LLC dba Vangard Labs