Home > Pill Identifier > Mucinex DM (dextromethorphan hydrobromide 60 MG / guaifenesin 1200 MG) 12 HR Extended Release Tablet

Pill Identifier Information of Mucinex DM (dextromethorphan hydrobromide 60 MG / guaifenesin 1200 MG) 12 HR Extended Release Tablet

Drug Information

Mucinex DM (dextromethorphan hydrobromide 60 MG / guaifenesin 1200 MG) 12 HR Extended Release Tablet

Imprint: Mucinex;1200
Shape: C48345
Color: C48325
Ingredients: Dextromethorphan; Guaifenesin
Size: 22.00
Score: 1
Rxtty: SY
Author: Physicians Total Care, Inc.
Inactive Ingredients: CARBOMER 934 / D&C YELLOW NO. 10 / HYPROMELLOSE / MAGNESIUM STEARATE / CELLULOSE, MICROCRYSTALLINE / SODIUM STARCH GLYCOLATE TYPE A POTATO>

Complete Information

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each extended-release bi-layer tablet)Purpose
    Dextromethorphan HBr 60 mgCough suppressant
    Guaifenesin 1200 mgExpectorant
  • Uses

    • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
    • temporarily relieves:
      • cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
      • the intensity of coughing
      • the impulse to cough to help you get to sleep
  • Warnings

    Do not use

    • for children under 12 years of age
    • 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

    • 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

    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

  • Other information

  • Inactive ingredients

    carbomer 934P, NF; D&C yellow #10 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 - 1200 mg Carton

    MAXIMUM STRENGTH

    NDC 54868-6106-0

    Mucinex®DM

    1200 mg guaifenesin & 60 mg dextromethorphan HBr
    extended-release bi-layer tablets

    EXPECTORANT & COUGH SUPPRESSANT

    12 HOUR

    NEW LOOK-
    SAME RELIEF

    Thins And Loosens Mucus

    Controls Cough

    14 EXTENDED-RELEASE BI-LAYER TABLETS

    Principal Display Panel
  • INGREDIENTS AND APPEARANCE
    MUCINEX DM 
    guaifenesin and dextromethorphan hydrobromide tablet, extended release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54868-6106(NDC:63824-072)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN1200 mg
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE60 mg
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER 934 (UNII: Z135WT9208)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    HYPROMELLOSE (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    Product Characteristics
    Colorwhite (yellow and white) Scoreno score
    ShapeOVALSize22mm
    FlavorImprint Code Mucinex;1200
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54868-6106-02 in 1 CARTON
    17 in 1 BLISTER PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02162004/19/2010
    Labeler - Physicians Total Care, Inc. (194123980)
    Establishment
    NameAddressID/FEIBusiness Operations
    Physicians Total Care, Inc.194123980relabel