MUCINEX- guaifenesin tablet, extended release 
American Health Packaging

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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.

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.

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) for information about the drug product or to report side effects. For information about packaging, contact American Health Packaging at 1-800-707-4621.

*The name MUCINEX ® and associated trademarked items are used with permission by Reckitt Benckiser

The drug product contained in this package is from NDC # 63824-008 Reckitt Benckiser.

Packaged and Distributed by American Health Packaging, 2550 John Glenn Avenue, Suite A, Columbus, OH 43217

057201
5500408/0915

Principal Display Panel – Carton – 600 mg

600 mg MUCINEX Carton

NDC 68084-572-01

Mucinex ®

600 mg guaifenesin
extended-release bi-layer tablets

EXPECTORANT

100 Tablets (10 x 10)

Principal Display Panel – Blister – 600 mg

600 mg Mucinex Tablet Blister

Mucinex ® (guaifenesin)
EXPECTORANT extended-
release bi-layer tablet     600 mg

MUCINEX 
guaifenesin tablet, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68084-572(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:68084-572-01100 in 1 BOX, UNIT-DOSE02/10/2016
1NDC:68084-572-111 in 1 BLISTER PACK; Type 0: Not a Combination Product
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02128202/10/2016
Labeler - American Health Packaging (929561009)
Establishment
NameAddressID/FEIBusiness Operations
American Health Packaging929561009repack(68084-572)

Revised: 10/2022
Document Id: ea3f438d-b00b-e171-e053-2995a90a32e7
Set id: 0129f47d-abc2-414c-b4e1-1064c5d6a623
Version: 5
Effective Time: 20221004
 
American Health Packaging