Label: DEXTROMETHORPHAN POLISTIREX EXTENDED RELEASE- dextromethorphan polistirex suspension

  • NDC Code(s): 45802-433-21
  • Packager: Padagis Israel Pharmaceuticals Ltd
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated November 9, 2021

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  • Active ingredient (in each 5 mL)

    Dextromethorphan polistirex equivalent to 30 mg dextromethorphan hydrobromide

  • 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

    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

  • Package/Label Principal Display Panel

    Compare to Delsym® active ingredient

    Dextromethorphan Polistirex Extended-Release Oral Suspension

    Cough Suppressant

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

    12 Hour Cough Relief

    Day or Night

    Alcohol-free

    Dosing Cup Included

    3 FL OZ (89 mL)

    Orange Flavored Liquid

    dextromethorphan polistirex image
  • INGREDIENTS AND APPEARANCE
    DEXTROMETHORPHAN POLISTIREX EXTENDED RELEASE 
    dextromethorphan polistirex suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:45802-433
    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)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    POLYVINYL ACETATE (UNII: 32K497ZK2U)  
    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)  
    Product Characteristics
    ColorORANGEScore    
    ShapeSize
    FlavorORANGEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:45802-433-211 in 1 CARTON09/10/2012
    189 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09113509/10/2012
    Labeler - Padagis Israel Pharmaceuticals Ltd (600093611)
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