MUCINEX D- guaifenesin and pseudoephedrine hydrochloride tablet, extended release

Mucinex D by

Drug Labeling and Warnings

Mucinex D by is a Prescription 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

• 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

How Supplied

Mucinex®D is supplied by Dispensing Solutions Inc. as follows:

NDC	Strength	Quantity/Form	Color	Source NDC
68258-3035-1	600 mg / 60 mg	18 Tablets	WHITE	63824-057-18

This product was:

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

And Relabeled By:

Dispensing Solutions Inc.
3000 West Warner Ave
Santa Ana, CA 92704
United States

PRINCIPAL DISPLAY PANEL - 600 mg Carton

NDC: 68258-3035-1

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

INGREDIENTS AND APPEARANCE

MUCINEX D 
guaifenesin and pseudoephedrine hydrochloride tablet, extended release

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 68258-3035(NDC:63824-057-18)
Route of Administration	ORAL

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

Product Characteristics
Color	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: 68258-3035-1	2 in 1 CARTON
1		9 in 1 BLISTER PACK

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA021585	02/08/2008

Labeler - Dispensing Solutions Inc. (066070785)

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