Drug Facts

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

Guaifenesin 600 mg

Purpose

Expectorant

helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

Do not use

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.

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

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)

carbomer 934P, NF; FD&C blue #1 aluminum lake; hypromellose, USP; magnesium stearate, NF; microcrystalline cellulose, NF; sodium starch glycolate, NF

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

Relabeling of "Additional Barcode" by:
Physicians Total Care, Inc.
Tulsa, OK 74146

NDC 54868-4750-0 20 Tablets

NDC 54868-4750-1 40 Tablets

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

EXPECTORANT

12
HOUR

NEW LOOK –
SAME RELIEF

✔Thins And Loosens Mucus✔Relieves Chest Congestion

MUCINEX
guaifenesin tablet, extended release

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 934 (UNII: Z135WT9208)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
HYPROMELLOSE (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
NDA	NDA021282	03/05/2003

Labeler - Physicians Total Care, Inc. (194123980)

Name	Address	ID/FEI	Business Operations
Establishment
Physicians Total Care, Inc.		194123980	relabel