MUCINEX- guaifenesin tablet, extended release

MUCINEX by

Drug Labeling and Warnings

MUCINEX by is a Otc medication manufactured, distributed, or labeled by Dispensing Solutions, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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)

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.

SPL UNCLASSIFIED SECTION

Distributed by:
Reckitt Benckiser Inc.
Parsippany, NJ 07054-0224
©RBI 2009

PRINCIPAL DISPLAY PANEL - 600mg Tablet

NDC: 55045-3143-2

Mucinex ®
600 mg guaifenesin extended-release bi-layer tablets

EXPECTORANT

Chest
Congestion

12
Hour

• Thins And Loosens Mucus
• Relieves Chest Congestion

20 EXTENDED-RELEASE BI-LAYER TABLETS

55045-3143-02 MUCINEX LABEL

INGREDIENTS AND APPEARANCE

MUCINEX 
guaifenesin tablet, extended release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55045-3143(NDC:63824-008)
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
CARBOMER HOMOPOLYMER TYPE B (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
Color	white (BLUE AND WHITE)	Score	no score
Shape	OVAL	Size	16mm
Flavor		Imprint Code	Mucinex;600
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55045-3143-2	20 in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA021282	05/12/2010

Labeler - Dispensing Solutions, Inc. (066070785)

Establishment
Name	Address	ID/FEI	Business Operations
Dispensing Solutions, Inc.		066070785	relabel, repack