Label: DELSYM- dextromethorphan polistirex syrup

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

Drug Label Information

Updated January 12, 2011

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

  • 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 TypeHUMAN OTC DRUGItem Code (Source)NDC:21695-517(NDC:63824-171)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN (UNII: 7355X3ROTS) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN30 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:21695-517-3090 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA01865809/04/2009
    DELSYM 
    dextromethorphan polistirex syrup
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21695-518(NDC:63824-172)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN (UNII: 7355X3ROTS) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN30 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:21695-518-3090 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA01865809/04/2009
    Labeler - Rebel Distributors Corp (118802834)
    Establishment
    NameAddressID/FEIBusiness Operations
    Rebel Distributors Corp118802834RELABEL, REPACK