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.

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

store between 20-25°C (68-77°F)
see window for lot number and expiration date

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

US Pat. 6,372,252 B1

US Pat. 6,955,821 B2

Inactive ingredients

carbomer homopolymer type B, FD&C blue #1 aluminum lake; hypromellose, USP; magnesium stearate, NF; microcrystalline cellulose, NF; sodium starch glycolate, NF

Keep Out of Reach of Children

Keep out of reach of children. This package is intended for institutional use only. This package is not child resistant. In case of overdose, get medical help or contact a Poison Control Center right away.

Dist. by:
Reckitt Benckiser Inc.
Parsippany, NJ 07054-0224

Repackaged by: Cardinal Health Zanesville, OH 43701

This Product was Repackaged By:

State of Florida DOH Central Pharmacy
104-2 Hamilton Park Drive
Tallahassee, FL 32304
United States

PACKAGE LABEL

Label Image for 53808-0871
600mg

MUCINEX
guaifenesin tablet, extended release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:53808-0871(NDC:55154-7776)
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	600 mg

Ingredient Name	Strength
Inactive Ingredients
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)

Product Characteristics
Color	WHITE (blue and white)	Score	no score
Shape	OVAL	Size	16mm
Flavor		Imprint Code	Mucinex;600
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:53808-0871-2	60 in 1 BLISTER PACK

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
NDA	NDA021282	01/01/2013

Labeler - State of Florida DOH Central Pharmacy (829348114)

Name	Address	ID/FEI	Business Operations
Establishment
State of Florida DOH Central Pharmacy		829348114	repack(53808-0871)

Mucinex®