Label: MUCINEX - guaifenesin tablet, extended release

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

Drug Label Information

Updated 12/09

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

    Close
  • Active ingredient (in each extended-release bi-layer tablet)

    Guaifenesin 600 mg

    Close
  • Purpose

    Expectorant

    Close
  • Uses

    helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

    Close
  • Warnings

    Do not use

    • for children under 12 years of age

    Ask a doctor before use if you have

    • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
    • cough accompanied by too much phlegm (mucus)

    Stop use and ask a doctor if

    • cough lasts more than 7 days, comes back, or occurs with 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.

    Close
  • Directions

    • do not crush, chew, or break tablet
    • take with a full glass of water
    • this product can be administered without regard for the timing of meals
    • adults and children 12 years of age and over: 1 or 2 tablets every 12 hours. Do not exceed 4 tablets in 24 hours.
    • children under 12 years of age: do not use
    Close
  • Other information

    • tamper evident: do not use if carton is open or if printed seal on blister is broken or missing
    • store between 20-25°C (68-77°F)
    Close
  • Inactive ingredients

    carbomer 934P, NF; FD&C blue #1 aluminum lake; hypromellose, USP; magnesium stearate, NF; microcrystalline cellulose, NF; sodium starch glycolate, NF

    Close
  • 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

    Close
  • PRINCIPAL DISPLAY PANEL - 600 mg Tablet Carton

    NDC 54868-4750-0  20 Tablets

    NDC 54868-4750-1  40 Tablets


    Mucinex®
    600 mg guaifenesin extended-release bi-layer tablets

    EXPECTORANT

    12
    HOUR

    NEW LOOK –
    SAME RELIEF

    Thins And Loosens MucusRelieves Chest Congestion
    PRINCIPAL DISPLAY PANEL - Tablet Carton
    Close
  • INGREDIENTS AND APPEARANCE
    MUCINEX 
    guaifenesin tablet, extended release
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:54868-4750(NDC:63824-008)
    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
    Inactive Ingredients
    Ingredient Name Strength
    CARBOMER 934 (UNII: Z135WT9208)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    HYPROMELLOSE (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    Product Characteristics
    Color white (blue and 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:54868-4750-1 2 in 1 CARTON
    1 10 in 1 BLISTER PACK
    2 NDC:54868-4750-0 4 in 1 CARTON
    2 10 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA021282 03/05/2003
    Labeler - Physicians Total Care, Inc. (194123980)
    Establishment
    Name Address ID/FEI Business Operations
    Physicians Total Care, Inc. 194123980 relabel
    Close