Label: DOUBLE TUSSIN INTENSE COUGH RELIEVER DM- dextromethorphan hydrobromide / guaifenesin liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated January 26, 2011

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

  • ACTIVE INGREDIENT

    Active ingredient per 5ml teaspoon

    Dextromethorphan Hydrobromide   20mg   Cough Suppressant
    Guaifenesin  300mg  Expectorant

  • INDICATIONS & USAGE

    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 (mucous)

  • 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 breastfeeding, 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) 

  • PURPOSE


    Purpose


    Dextromethorphan Hydrobromide      Cough Suppressant

    Guaifenesin                                     Expectorant
  • INACTIVE INGREDIENT


    Cherry Flavor,Citric Acid,Menthol,Polyethylene Glycol,Propylene Glycol,Purified Water,

    Sodium Benzoate,Sodium Saccharin,Sorbitol.


  • PRINCIPAL DISPLAY PANEL

    image of carton

  • INGREDIENTS AND APPEARANCE
    DOUBLE TUSSIN INTENSE COUGH RELIEVER  DM
    dextromethorphan hydrobromide / guaifenesin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10956-674
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg  in 5 mL
    Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ) Guaifenesin300 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    ColorredScore    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10956-674-011 in 1 CARTON
    1NDC:10956-674-04120 mL in 1 BOTTLE, PLASTIC
    2NDC:10956-674-08240 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34108/02/2011
    Labeler - Reese Pharmaceutical Co (004172052)
    Registrant - Reese Pharmaceutical Co (004172052)
    Establishment
    NameAddressID/FEIBusiness Operations
    Reese Pharmaceutical Co004172052relabel, repack