Label: SAFETUSSIN DM - dextromethorphan hydrobromide and guaifenesin liquid

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

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 09/13

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  • ACTIVE INGREDIENT

    Dextromethorphan HBr, USP 10 mg

    Guaifenesin, USP 100 mg

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  • PURPOSE

    Cough suppressant

    Expectorant

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  • KEEP OUT OF REACH OF CHILDREN

    In case of overdose, get medical help or contact a Poison Control Center right away

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  • INDICATIONS & USAGE

    temporarily relieves cough due to minor throat and bronchial irritation  
    loosen phlegm (mucus)
    helps rid bronchial passages of phlegm (mucus)

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  • DOSAGE & ADMINISTRATION


    take every 4 hours not more than 6 doses in any 24-hour period

    adults and children 12 years and over 2 tsp every 4 hours

    children under 12 years do not use

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  • INACTIVE INGREDIENT

    Aspartame ,BENZOIC ACID   , CITRIC ACID MONOHYDRATE ,glycerin ,methylparaben ,nautral mint flavor  ,propylene glycol,  propylparaben ,
    , purified water 

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  • WARNINGS

    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.

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  • INGREDIENTS AND APPEARANCE
    SAFETUSSIN  DM
    dextromethorpan guaifenesin liquid
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:55505-111
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Dextromethorphan Hydrobromide (Dextromethorphan) Dextromethorphan Hydrobromide 10 mg  in 5 mL
    GUAIFENESIN (GUAIFENESIN) GUAIFENESIN 100 mg  in 5 mL
    Inactive Ingredients
    Ingredient Name Strength
    Aspartame  
    BENZOIC ACID  
    CITRIC ACID MONOHYDRATE  
    glycerin  
    methylparaben  
    MINT  
    propylene glycol  
    propylparaben  
    WATER  
    Product Characteristics
    Color      Score     
    Shape Size
    Flavor MINT Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:55505-111-33 120 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 11/29/2010
    Labeler - Kramer Laboratories (122720675)
    Establishment
    Name Address ID/FEI Business Operations
    Denison Pharmecuticals 001207208 manufacture(55505-111)
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