MUCINEX- guaifenesin tablet, extended release 
Cardinal Health 107, LLC

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Mucinex ®

Drug Facts

Active ingredient
(in each extended-release bi-layer tablet)

Guaifenesin 600 mg

Purpose

Expectorant

12 Hour

Unique Bi-Layer Tablet

White Layer – Immediate Release Layer

Blue Layer – Extended-Release Layer

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.

This Unit Dose package is not child resistant and is Intended for Institutional Use Only. KEEP THIS AND ALL DRUGS OUT OF REACH OF CHILDREN.

If dispensed for outpatient use, a child-resistant container should be utilized.

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

FOR YOUR PROTECTION: Do not use if blister is torn or broken.
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) 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

Americanhealthpackaging.com

An AmerisourceBergen Company

Distributed by:

Cardinal Health

Dublin, OH 43017

L5315882-10124

L5315882-20124

057201
5500408/0915

Principal Display Panel

Mucinex 600 mg

Guaifenesin

EXPECTORANT

10 Extended-Release Bi-Layer Tablets

Bag Label
MUCINEX 
guaifenesin tablet, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55154-4680(NDC:68084-572)
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)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (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:55154-4680-010 in 1 BAG01/01/2016
11 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02128201/01/2016
Labeler - Cardinal Health 107, LLC (118546603)

Revised: 2/2024
Document Id: 8746d6ba-b763-49b7-b6d1-a3e72cb09fe1
Set id: 8b0d6d01-f1dd-41b0-a71e-46668bc9cde6
Version: 5
Effective Time: 20240202
 
Cardinal Health 107, LLC