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Delsym (Rebel Distributors Corp)

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SYRUP 90 mL in 1 BOTTLE (21695-517-30) Label Information

Complete Delsym Information

  • Active ingredient

    Dextromethorphan Polistirex


  • Purpose

    Use(s)

    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


  • Keep Out of Reach of Children


  • Uses

    Use(s)

    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

    Warnings

    Do not use

    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 as occurs with smoking, asthma or emphysema

    cough that occurs with too much phlegm (mucus)

    Ask a doctor or pharmacist before use if you are

    When using this product

    Stop use and ask a doctor if

    Stop use and ask a doctor if 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

    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.


  • Directions

    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

    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 7 mg

    store at 20°-25°C (68°-77°F)

    dosing cup provided

    Drug Facts

    Distributed by: Reckitt Benckiser Inc., Parsippany, NJ 07054-0224 ©RBI 2009


  • Inactive ingredients

    Inactive ingredients

    citric acid anhydrous, D&C Red #33, edetate disodium, ethylcellulose, FD&C Blue #1, flavor, high fructose corn syrup, methylparaben, polyethylene glycol 3350, polysorbate 80, propylene glycol, propylparaben,

    purified water, sucrose, tragacanth, vegetable oil, xanthan gum


  • Package/Label Principal Display Panel

    Delsym 30mg/ 5ml


  • Package/Label Principal Display Panel

    Delsym 30mg/ 5ml


  • INGREDIENTS AND APPEARANCE
    DELSYM 
    dextromethorphan polistirex syrup
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:21695-517(NDC:63824-171)
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DEXTROMETHORPHAN (UNII: 7355X3ROTS) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN 30 mg  in 5 mL
    Inactive Ingredients
    Ingredient Name Strength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    ETHYLCELLULOSES (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)  
    CORN OIL (UNII: 8470G57WFM)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:21695-517-30 90 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA018658 09/04/2009
    DELSYM 
    dextromethorphan polistirex syrup
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:21695-518(NDC:63824-172)
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DEXTROMETHORPHAN (UNII: 7355X3ROTS) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN 30 mg  in 5 mL
    Inactive Ingredients
    Ingredient Name Strength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    ETHYLCELLULOSES (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)  
    CORN OIL (UNII: 8470G57WFM)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:21695-518-30 90 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA018658 09/04/2009
    Labeler - Rebel Distributors Corp (118802834)
    Establishment
    Name Address ID/FEI Business Operations
    Rebel Distributors Corp 118802834 RELABEL, REPACK