MUCINEX- guaifenesin tablet, extended release 
Cardinal Health

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Mucinex® 600 mg

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

•
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)

12 Hour

Relieves Chest Congestion

Thins and Loosens Mucus

Immediate and Extended Release

Blue layer - Extended Release Layer

White layer - Immediate Release Layer

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.

Please visit our web site www.mucinex.com

Dist. by: Reckitt Benckiser Inc.

Parsippany, NJ 07054-0224

Made in England

Cardinal Health

Zanesville, OH 43701

L4517835-11016

L4517835-21016

Principal Display Panel

NDC: 55154-7777-6

Mucinex®

600 mg (guaifenesin)

Extended-Release Bi-Layer Tablet

pouch label

Principal Display Panel

NDC: 55154-7777-0

Mucinex®

600 mg

Guaifenesin

EXPECTORANT

10 Extended-Release Bi-Layer Tablets

bag label

Principal Display Panel

NDC: 55154-7777-4

Mucinex®

600 mg (guaifenesin)

500 Extended-Release Bi-Layer Tablets

Carton Label
MUCINEX 
guaifenesin tablet, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55154-7777(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)  
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:55154-7777-010 in 1 BAG07/22/201001/31/2018
11 in 1 POUCH; Type 0: Not a Combination Product
2NDC:55154-7777-4500 in 1 CARTON07/22/201003/31/2012
2NDC:55154-7777-61 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02128207/22/201001/31/2018
Labeler - Cardinal Health (603638201)

Revised: 1/2019
Document Id: 3650b616-87d1-4bda-8d3e-caa35b46608d
Set id: 8ebc5b8c-a578-4f73-b5a1-3ea18a6b646e
Version: 9
Effective Time: 20190130
 
Cardinal Health