Mucinex D

MUCINEX D — guaifenesin and pseudoephedrine hydrochloride tablet, extended release
Dispensing Solutions Inc.

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

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

Principal Display Panel
(click image for full-size original)
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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GUAIFENESIN (Guaifenesin) GUAIFENESIN 600 mg
PSEUDOEPHEDRINE HYDROCHLORIDE (Pseudoephedrine) 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 Multilevel Packaging
1 NDC:68258-3035-1 2 BLISTER PACK (BLISTER PACK) in 1 CARTON contains a BLISTER PACK
1 9 TABLET, EXTENDED RELEASE (TABLET) in 1 BLISTER PACK This package is contained within the CARTON (68258-3035-1)
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 Operations
Dispensing Solutions Inc. 066070785 repack, relabel

Revised: 03/2010 Dispensing Solutions Inc.

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2021. All Rights Reserved.