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Guaifenesin Extended Release Extended Release

Dosage form: tablet, extended release
Ingredients: GUAIFENESIN 600mg
Labeler: NCS HealthCare of KY, Inc dba Vangard Labs
NDC Code: 0615-7712

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 EXTENDED RELEASE  EXTENDED RELEASE
guaifenesin tablet, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0615-7712(NDC:45802-498)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN600 mg
Inactive Ingredients
Ingredient NameStrength
COPOVIDONE K25-31 
SILICON DIOXIDE 
ZINC STEARATE 
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) 
Product Characteristics
ColorWHITE ((off-white)) Scoreno score
ShapeROUNDSize12mm
FlavorImprint CodeL498
Contains    
Packaging
#Item CodePackage Description
1NDC:0615-7712-3930 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07891203/28/2012
Labeler - NCS HealthCare of KY, Inc dba Vangard Labs (050052943)
Establishment
NameAddressID/FEIOperations
NCS HealthCare of KY, Inc dba Vangard Labs050052943REPACK(0615-7712)

Revised: 07/2015
 
NCS HealthCare of KY, Inc dba Vangard Labs

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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