MUCINEX- guaifenesin tablet, extended release 
Atlantic Biologicals Corps

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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

Other information

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

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MUCINEX 
guaifenesin tablet, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17856-0008(NDC:63824-008)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ) Guaifenesin600 mg
Inactive Ingredients
Ingredient NameStrength
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
Product Characteristics
ColorWHITE (blue and white) Scoreno score
ShapeOVALSize16mm
FlavorImprint Code Mucinex;600
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:17856-0008-21 in 1 BLISTER PACK; Type 0: Not a Combination Product01/11/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02128207/03/2012
Labeler - Atlantic Biologicals Corps (047437707)
Establishment
NameAddressID/FEIBusiness Operations
Atlantic Biologicals Corps047437707REPACK(17856-0008) , relabel(17856-0008)

Revised: 1/2021
Document Id: 74e9b8e0-851a-4ea9-a456-a73def102845
Set id: 40c67cca-f202-4652-9507-2442d26cfd67
Version: 6
Effective Time: 20210111
 
Atlantic Biologicals Corps