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Mucinex by Cardinal Health

Dosage form: tablet, extended release
Ingredients: GUAIFENESIN 600mg
Labeler: Cardinal Health
NDC Code: 55154-4680

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

057201
5500408/0915

L5315882-10318

L5315882-20318

Principal Display Panel

Mucinex 600 mg

Guaifenesin

EXPECTORANT

10 Extended-Release Bi-Layer Tablets

MUCINEX 
guaifenesin tablet, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55154-4680(NDC:68084-572)
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 
HYPROMELLOSE, UNSPECIFIED 
MAGNESIUM STEARATE 
MICROCRYSTALLINE CELLULOSE 
Product Characteristics
Colorwhite (blue and white) Scoreno score
ShapeOVALSize16mm
FlavorImprint CodeMucinex;600
Contains    
Packaging
#Item CodePackage Description
1NDC:55154-4680-010 BLISTER PACK in 1 CARTON
11 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02128201/01/2016
Labeler - Cardinal Health (603638201)

 
Cardinal Health

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Medically reviewed on Oct 17, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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