Label: COUGH DM- dextromethorphan polistirex suspension

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated November 18, 2024

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  • Active ingredient (in each 5 mL)

    Dextromethorphan polistirex equivalent to 30 mg dextromethorphan hydrobromide, USP

  • Purpose

    Cough suppressant

  • Uses

    temporarily relieves

    •
    cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
    •
    the impulse to cough to help you get to sleep
  • 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.

    Allergy Alert: Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions.

    Ask a doctor before use if you have

    •
    chronic cough that lasts as occurs with smoking, asthma or emphysema
    •
    cough that occurs with too much phlegm (mucus)

    Stop use and ask a doctor if

    •
    side effects occur. You may report side effects to FDA at 1-800-FDA-1088.
    •
    cough lasts more than 7 days, cough comes back, or occurs with fever, rash or headache that lasts. These could be signs of a serious condition.

    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 1-800-222-1222.

  • Directions

    •
    shake bottle well before use
    •
    measure only with dosing cup provided. Do not use dosing cup with other products.
    •
    dose as follows or as directed by doctor
    •
    mL = milliliter

    adults and children 12 years of age and over

    10 mL every 12 hours, not to exceed 20 mL in 24 hours

    children 6 to under 12 years of age

    5 mL every 12 hours, not to exceed 10 mL in 24 hours

    children 4 to under 6 years of age

    2.5 mL every 12 hours, not to exceed 5 mL in 24 hours

    children under 4 years of age

    do not use
  • Other information

    •
    each 5 mL contains: sodium 5 mg
    •
    store at 20° to 25°C (68° to 77°F)
    •
    dosing cup provided
  • Inactive Ingredients

    D&C Red #30 aluminum lake, D&C Yellow #10 aluminum lake, flavor, glycerin, high fructose corn syrup, methylparaben, polysorbate 80, polyvinyl acetate, povidone, propylparaben, purified water, sodium metabisulfite, sodium polystyrene sulfonate, sucrose, tartaric acid, tragacanth gum, triacetin, xanthan gum

  • Questions or comments?

    1-800-719-9260

    DISTRIBUTED BY:

    ATLANTIC BIOLOGICALS CORP.

    MIAMI, FL 33179

  • Package/Label Principal Display Panel

    Cough DM

    Dextromethorphan Polistirex Extended-Release Oral Suspension

    Cough Suppressant

    12 HOUR COUGH RELIEF

    Dosing Cup Included

    Orange-Flavored Liquid

    Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions

    COMPARE TO the Active Ingredient of DELSYM®

    Alcohol-free

    image description

    image description

  • INGREDIENTS AND APPEARANCE
    COUGH DM 
    dextromethorphan polistirex suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17856-6312(NDC:0904-6312)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE30 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    POLISTIREX (UNII: 5H9W9GTW27)  
    HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
    SODIUM POLYSTYRENE SULFONATE (UNII: 1699G8679Z)  
    SUCROSE (UNII: C151H8M554)  
    TARTARIC ACID (UNII: W4888I119H)  
    TRAGACANTH (UNII: 2944357O2O)  
    TRIACETIN (UNII: XHX3C3X673)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    POLYVINYL ACETATE (UNII: 32K497ZK2U)  
    Product Characteristics
    ColorORANGEScore    
    ShapeSize
    FlavorORANGEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:17856-6312-15 mL in 1 CUP; Type 0: Not a Combination Product11/18/2024
    2NDC:17856-6312-210 mL in 1 CUP; Type 0: Not a Combination Product11/18/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09113509/06/2012
    Labeler - ATLANTIC BIOLOGICALS CORP. (047437707)
    Establishment
    NameAddressID/FEIBusiness Operations
    UNIT DOSE SOLUTION360804194repack(17856-6312)
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