Drug Facts

Active ingredients (in each extended-release bi-layer tablet)	Purpose
Guaifenesin 600 mg	Expectorant
Pseudoephedrine HCl 60 mg	Nasal Decongestant

Uses

helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
temporarily relieves nasal congestion due to:
- common cold
- hay fever
- upper respiratory allergies
temporarily restores freer breathing through the nose
promotes nasal and/or sinus drainage
temporarily relieves sinus congestion and pressure

Warnings

Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

heart disease
high blood pressure
thyroid disease
diabetes
trouble urinating due to an enlarged prostate gland
persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
cough accompanied by too much phlegm (mucus)

When using this product

do not use more than directed

Stop use and ask a doctor if

you get nervous, dizzy, or sleepless
symptoms do not get better within 7 days, come back or occur with a 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 timing of meals
adults and children 12 years and older: 2 tablets every 12 hours; not more than 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 at 20-25°C (68-77°F)

Inactive ingredients

carbomer 934P, NF; FD&C yellow #6 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

PRINCIPAL DISPLAY PANEL - 600 mg Carton

NDC 54868-5849-0

Mucinex®D

600 mg guaifenesin & 60 mg pseudoephedrine HCl
extended-release bi-layer tablets

EXPECTORANT & NASAL DECONGESTANT

12 HOUR

NEW LOOK-
SAME RELIEF

Thins And Loosens Mucus

Clears Nasal/Sinus Congestion

18 EXTENDED-RELEASE BI-LAYER TABLETS

Principal Display Panel

MUCINEX D
guaifenesin and pseudoephedrine hydrochloride tablet, extended release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:54868-5849(NDC:63824-057)
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	600 mg
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F)	PSEUDOEPHEDRINE HYDROCHLORIDE	60 mg

Ingredient Name	Strength
Inactive Ingredients
CARBOMER 934 (UNII: Z135WT9208)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
HYPROMELLOSE (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)

Product Characteristics
Color	orange, white	Score	no score
Shape	OVAL	Size	16mm
Flavor		Imprint Code	Mucinex;600
Contains

#	Item Code	Package Description
Packaging
1	NDC:54868-5849-0	2 in 1 CARTON
1		9 in 1 BLISTER PACK

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
NDA	NDA021585	01/07/2008

Labeler - Physicians Total Care, Inc. (194123980)

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