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Mucinex by Atlantic Biologicals Corps

Dosage form: tablet, extended release
Ingredients: Guaifenesin 600mg
Labeler: Atlantic Biologicals Corps
NDC Code: 17856-0008

Mucinex ®

Drug Facts

Active ingredient (in each extended-release bi-layer 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.

ask a health professional before use. If pregnant or breast-feeding,

In case of overdose, get medical help or contact a Poison Control Center right away. Keep out of reach of children.

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 or 2 tablets every 12 hours. Do not exceed 4 tablets in 24 hours.
  • children under 12 years of age: do not use

Other information
  • tamper evident: do not use if carton is open or if printed seal on blister is broken or missing
  • store between 20-25°C (68-77°F)

Inactive ingredients

carbomer homopolymer type B; FD&C blue #1 aluminum lake; hypromellose, USP; magnesium stearate, NF; microcrystalline cellulose, NF; sodium starch glycolate, NF

Questions?

1-866-MUCINEX (1-866-682-4639)

You may also report side effects to this phone number.

Dist. by: Reckitt Benckiser Parsippany, NJ 07054-0224

MUCINEX (GUAIFENESIN) TABLET, EXTENDED RELEASE
MUCINEX 
guaifenesin tablet, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17856-0008(NDC:63824-008)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Guaifenesin (Guaifenesin) Guaifenesin600 mg
Inactive Ingredients
Ingredient NameStrength
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) 
FD&C BLUE NO. 1 
ALUMINUM OXIDE 
HYPROMELLOSES 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
Product Characteristics
ColorWHITE (blue and white) Scoreno score
ShapeOVALSize16mm
FlavorImprint CodeMucinex;600
Contains    
Packaging
#Item CodePackage Description
1NDC:17856-0008-21 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02128207/03/2012
Labeler - Atlantic Biologicals Corps (047437707)
Registrant - Atlantic Biologicals Corps (047437707)
Establishment
NameAddressID/FEIOperations
Atlantic Biologicals Corps047437707REPACK(17856-0008)

Revised: 07/2012
 
Atlantic Biologicals Corps

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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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