Your browser does not support JavaScript! MUCINEX D (GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [DISPENSING SOLUTIONS INC.]
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RxNorm Names

MUCINEX D (guaifenesin and pseudoephedrine hydrochloride) tablet, extended release
[Dispensing Solutions Inc.]


Category DEA Schedule Marketing Status
HUMAN PRESCRIPTION DRUG LABEL New Drug Application
Drug Label Sections

Drug Facts

Active ingredients (in each extended-release bi-layer tablet)Purpose
Guaifenesin 600 mgExpectorant
Pseudoephedrine HCl 60 mgNasal 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:

NDCStrengthQuantity/FormColorSource NDC
68258-3035-1600 mg / 60 mg18 TabletsWHITE63824-057-18

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

Principal Display Panel
MUCINEX D 
guaifenesin and pseudoephedrine hydrochloride tablet, extended release
Product Information
Product TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:68258-3035(NDC:63824-057-18)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (Guaifenesin) GUAIFENESIN600 mg
PSEUDOEPHEDRINE HYDROCHLORIDE (Pseudoephedrine) PSEUDOEPHEDRINE HYDROCHLORIDE60 mg
Product Characteristics
ColorWHITEScoreno score
ShapeOVALSize16mm
FlavorImprint Code Mucinex;600
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68258-3035-12 in 1 CARTON
19 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02158502/08/2008
Labeler - Dispensing Solutions Inc. (066070785)
Establishment
NameAddressID/FEIBusiness Operations
Dispensing Solutions Inc.066070785repack, relabel

Revised: 3/2010
 
Dispensing Solutions Inc.

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