Label: DEXTROMETHORPHAN POLISTIREX EXTENDED RELEASE- dextromethorphan hydrobromide suspension 

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

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 (in each 5 mL)

    Dextromethorphan polistirex equivalent to 30 mg dextromethorphan hydrobromide, USP

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  • Purpose

    Cough suppressant

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  • 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
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  • 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.

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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 1-800-222-1222.

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  • 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

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  • Other information

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

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  • Questions or comments?

    1-800-719-9260

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  • 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

    Alcohol-free

    Orange-Flavored Liquid

    Dosing Cup Included

    Dextromethorphan Polistirex Extended-Rlease Oral Suspension Carton Image 1
    Dextromethorphan Polistirex Extended-Rlease Oral Suspension Carton Image 2
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  • INGREDIENTS AND APPEARANCE
    DEXTROMETHORPHAN POLISTIREX EXTENDED RELEASE 
    dextromethorphan polistirex suspension
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:45802-433
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE 30 mg  in 5 mL
    Inactive Ingredients
    Ingredient Name Strength
    POLISTIREX  
    HIGH FRUCTOSE CORN SYRUP  
    GLYCERIN  
    METHYLPARABEN  
    POLYSORBATE 80  
    POVIDONES  
    PROPYLPARABEN  
    WATER  
    SODIUM METABISULFITE  
    SODIUM POLYSTYRENE SULFONATE  
    SUCROSE  
    TARTARIC ACID  
    TRAGACANTH  
    TRIACETIN  
    XANTHAN GUM  
    Product Characteristics
    Color ORANGE Score     
    Shape Size
    Flavor ORANGE Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:45802-433-21 1 in 1 CARTON
    1 89 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA091135 09/10/2012
    Labeler - Perrigo New York Inc (078846912)
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