MUCINEX D (GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]

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  • MUCINEX D (GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]

MUCINEX D (GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]
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NDC 54868-5849-0
Set ID 9ae3a598-a423-4007-9ca6-95c687cb56d5
Category HUMAN OTC DRUG LABEL
Packager Physicians Total Care, Inc.
Generic Name
Product Class alpha-Adrenergic Agonist
Product Number
Application Number NDA021585
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    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

  • SPL UNCLASSIFIED SECTION

    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

  • INGREDIENTS AND APPEARANCE
    MUCINEX D 
    guaifenesin and pseudoephedrine hydrochloride tablet, extended release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54868-5849(NDC:63824-057)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN600 mg
    PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE60 mg
    Inactive Ingredients
    Ingredient NameStrength
    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
    Colororange, whiteScoreno score
    ShapeOVALSize16mm
    FlavorImprint Code Mucinex;600
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54868-5849-02 in 1 CARTON
    19 in 1 BLISTER PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02158501/07/2008
    Labeler - Physicians Total Care, Inc. (194123980)
    Establishment
    NameAddressID/FEIBusiness Operations
    Physicians Total Care, Inc.194123980relabel
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