Label: DELSYM- dextromethorphan suspension, extended release

  • NDC Code(s): 63824-171-22, 63824-171-63, 63824-171-65, 63824-171-75
  • Packager: RB Health (US) LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated October 17, 2019

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active ingredient (in each 5 mL)

    Dextromethorphan polistirex equivalent to 30 mg dextromethorphan hydrobromide

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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.

    Ask a doctor before use if you have

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

    Stop use and ask a doctor if cough lasts more than 7 days, 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.

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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 a 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 7 mg
    • store at 20-25°C (68-77°F)
    • dosing cup provided
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  • Inactive ingredients

    citric acid anhydrous, D&C red no. 33, edetate disodium, ethylcellulose, FD&C blue no. 1, flavor, high fructose corn syrup, methylparaben, partially hydrogenated vegetable oil (soybean, cottonseed), polyethylene glycol 3350, polysorbate 80, propylene glycol, propylparaben, purified water, sucrose, tragacanth, xanthan gum

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  • Questions?

    1-866-682-4639
    You may also report side effects to this phone number.

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  • SPL UNCLASSIFIED SECTION

    Distributed by:
    RB Health (US)
    Parsippany, NJ
    07054-0224

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  • PRINCIPAL DISPLAY PANEL - 148 mL Bottle Carton

    NDC 63824-171-65

    Delsym®

    Dextromethorphan Polistirex
    Extended-Release Suspension (Cough Suppressant)

    COUGH

    12
    HOUR
    COUGH RELIEF
    ®

    Day or Night

    Grape
    Flavored Liquid

    148 mL (5 fl oz)

    SULFITE FREE
    ALCOHOL FREE

    PRINCIPAL DISPLAY PANEL - 148 mL Bottle Carton
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  • INGREDIENTS AND APPEARANCE
    DELSYM 
    dextromethorphan suspension, extended release
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:63824-171
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Dextromethorphan (UNII: 7355X3ROTS) (Dextromethorphan - UNII:7355X3ROTS) Dextromethorphan Hydrobromide 30 mg  in 5 mL
    Inactive Ingredients
    Ingredient Name Strength
    Polistirex (UNII: 5H9W9GTW27)  
    anhydrous citric acid (UNII: XF417D3PSL)  
    D&C Red NO. 33 (UNII: 9DBA0SBB0L)  
    edetate disodium (UNII: 7FLD91C86K)  
    ethylcellulose, unspecified (UNII: 7Z8S9VYZ4B)  
    FD&C Blue NO. 1 (UNII: H3R47K3TBD)  
    high fructose corn syrup (UNII: XY6UN3QB6S)  
    methylparaben (UNII: A2I8C7HI9T)  
    polyethylene glycol 3350 (UNII: G2M7P15E5P)  
    polysorbate 80 (UNII: 6OZP39ZG8H)  
    propylene glycol (UNII: 6DC9Q167V3)  
    propylparaben (UNII: Z8IX2SC1OH)  
    water (UNII: 059QF0KO0R)  
    sucrose (UNII: C151H8M554)  
    tragacanth (UNII: 2944357O2O)  
    xanthan gum (UNII: TTV12P4NEE)  
    Product Characteristics
    Color PURPLE Score     
    Shape Size
    Flavor GRAPE Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:63824-171-63 1 in 1 CARTON 05/04/2010
    1 89 mL in 1 BOTTLE; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)
    2 NDC:63824-171-65 1 in 1 CARTON 05/04/2010
    2 148 mL in 1 BOTTLE; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)
    3 NDC:63824-171-75 1 in 1 CARTON 05/04/2010
    3 15 mL in 1 BOTTLE; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)
    4 NDC:63824-171-22 2 in 1 CELLO PACK 05/04/2010
    4 1 in 1 CARTON
    4 148 mL in 1 BOTTLE; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA018658 05/04/2010
    Labeler - RB Health (US) LLC (081049410)
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