QUALITY CHOICE MUCUS RELIEF DM DM (DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN) TABLET [CHAIN DRUG MARKETING ASSOCIATION]

QUALITY CHOICE MUCUS RELIEF DM DM (DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN) TABLET [CHAIN DRUG MARKETING ASSOCIATION]
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NDC 63868-753-50
Set ID 1c33a01f-1186-4a19-b639-a9cd49245220
Category HUMAN OTC DRUG LABEL
Packager Chain Drug Marketing Association
Generic Name
Product Class
Product Number
Application Number PART341
  • ACTIVE INGREDIENT

    Active ingredient - (per tablet)

    Dextromethorphan Hydrobromide   20mg

    Guaifenesin  400mg

  • PURPOSE

    Purpose

    Cough Suppressant

    Expectorant

  • Uses

    ■ Temporarily relieves cough due to minor throat and bronchial irritation as may occur with a common cold
    ■ Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus
    ■ Helps make coughs more productive.

  • Warnings

    Do not use  ■ if you are now taking a prescription monoamine oxidase (inhiMor~MAIO) (Certain drugs for depression, psychiatric or emotional conditioners or Parkinson's disease)or for 2 weeks after stopping MAIO drug, If you do not know if your prescription drug contains an MAIO, ask your doctor or pharmacist before using this product.

  • ASK DOCTOR

    Ask doctor before use if you have
    ■ persistent or chronic cough, such as occurs with smoking, asthma, bronchitis or emphysma
    ■ cough is accompanied by excessive phlegm (mucus)

  • STOP USE

    Stop use and ask doctor if
    ■ symptoms are accompanied by fever, rash or persistent headache
    ■ cough persists for more than 1 week or tends to recur.
    A persistent cough may be a sign of a serious condition.

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In  case of overdose, get medical help or contact a Poison Center immediately.

  • DOSAGE & ADMINISTRATION

    Directions
    Adults and children 12 years of age and over:take 1 tablet every 4 hours as needed.
    Children 6 to 10 under 12 years of age: take 1/2 tablet every 4 hours as needed.
    Children under 6 years of age: consult a doctor.   
    Do not exceed 6 doses in a 24 hour period or as directed by a doctor

  • Other Information

    Store at 15°-30°C (59°-86°F)

  • INACTIVE INGREDIENT

    Inactive Ingredients magnesium stearate, microcrystalline cellulose. May also contain (colloidal) silicon dioxide, (co) povidone, dicalcium phosphate, maltodextrin, sodium starch glycolate, stearic acid.

  • PRINCIPAL DISPLAY PANEL

    image of display

  • INGREDIENTS AND APPEARANCE
    QUALITY CHOICE MUCUS RELIEF DM  DM
    dextromethorphan hydrobromide / guaifenesin tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-753
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg
    Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ) Guaifenesin400 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorwhiteScore2 pieces
    ShapeOVALSize17mm
    FlavorImprint Code PH073
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63868-753-501 in 1 CARTON08/01/2012
    150 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34108/01/2012
    Labeler - Chain Drug Marketing Association (011920774)
    Registrant - Reese Pharmaceutical Co (004172052)
    Establishment
    NameAddressID/FEIBusiness Operations
    Reese Pharmaceutical Co004172052relabel(63868-753) , repack(63868-753)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharbest557054835manufacture(63868-753)