Label: MUCINEX D - guaifenesin and pseudoephedrine hydrochloride tablet, extended release

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated 03/10

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • ACTIVE INGREDIENT

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

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  • 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
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  • 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)
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  • Inactive ingredients

    carbomer 934P, NF; FD&C yellow #6 aluminum lake; hypromellose, USP; magnesium stearate, NF; microcrystalline cellulose, NF; sodium starch glycolate, NF

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  • 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

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  • 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
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  • 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 DEA Schedule     
    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
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