Label: COUGH SYRUP DM - dextromethorphan hydrobromide and guaifenesin syrup 

  • NDC Code(s): 35418-119-37, 35418-119-42
  • Packager: Zee Medical Inc
  • 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 11/12

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

  • ACTIVE INGREDIENT

    Active Ingredient (in each 5 ml)  Guaifenesin 100 mg, Dextromethorphan HBr 10 mg

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  • PURPOSE

    Purpose-Cough Suppressant, Expectorant

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  • INDICATIONS & USAGE

    Uses ■ temporarily relieves cough due to minor throat and
    bronchial irritation that occur with a cold or inhaled irritants
    ■ helps loosen phlegm (mucus) and thin bronchial secretions to
    make coughs more productive

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  • DOSAGE & ADMINISTRATION

    Directions
    ■ shake well before using
    ■ adults and children over 12 years: take
    2 teaspoons (one packet) every 4 hours
    ■ do not exceed 12 teaspoons (6 packets) in 24 hours
    ■ children under 12 years: do not use Close
  • WARNINGS


    Warnings
    Do not use 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.
    Stop use and ask a doctor if cough lasts more than 7 days,
    comes back, or is accompanied by fever, rash, or persistent
    headache. These could be signs of a serious condition.➧
    Ask a doctor before use if you have
    ■ cough that occurs with too much phlegm (mucus)
    ■ cough that lasts or is chronic such as occurs with smoking,
    asthma, chronic bronchitis, or emphysema

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  • PREGNANCY OR BREAST FEEDING

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

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  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN. In case of overdose,  
    get medical help or contact a Poison Control Center right away.  
    Prompt medical attention is critical for adults as well as for  
    children even if you do not notice any signs or symptoms.

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  • INACTIVE INGREDIENT

    Inactive ingredients
    citric acid, FDC red 40, flavor, glycerin, methyl
    paraben, propylene glycol, propyl paraben, purified
    water, sodium citrate, sucralose

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  • PRINCIPAL DISPLAY PANEL

    MM1Cough Syrup Box 1

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  • INGREDIENTS AND APPEARANCE
    COUGH SYRUP DM 
    guaifenesin, dextromethorpham hbr syrup
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:35418-119
    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
    SODIUM CITRATE  
    SUCRALOSE  
    WATER  
    PROPYLENE GLYCOL  
    GLYCERIN  
    PROPYLPARABEN  
    METHYLPARABEN  
    FD&C RED NO. 40  
    CITRIC ACID MONOHYDRATE  
    Product Characteristics
    Color red (cherry red) Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:35418-119-37 6 in 1 CARTON
    1 NDC:35418-119-42 10 mL in 1 PACKET
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 06/12/2012
    Labeler - Zee Medical Inc (009645623)
    Registrant - Ultra Seal Corporation (085752004)
    Establishment
    Name Address ID/FEI Business Operations
    Ultratab Laboratories, Inc. 151051757 manufacture(35418-119)
    Establishment
    Name Address ID/FEI Business Operations
    Ultra Seal Corporation 085752004 repack(35418-119)
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