Label: DELSYM (DEXTROMETHORPHAN)- dextromethorphan suspension, extended release

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

Drug Label Information

Updated May 4, 2016

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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

    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. Do not use

    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)

    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. Stop use and ask a doctor if

    ask a health professional before use. If pregnant or breast-feeding,

    In case of overdose, get medical help or contact a Poison Control Center right away. Keep out of reach of children.

  • 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 over10 mL every 12 hours, not to exceed 20 mL in 24 hours
    children 6 to under 12 years of age5 mL every 12 hours, not to exceed 10 mL in 24 hours
    children 4 to under 6 years of age2.5 mL every 12 hours, not to exceed 5 mL in 24 hours
    children under 4 years of agedo not use
  • Other information

    • each 5 mL contains: sodium 7 mg
    • store at 20-25°C (68-77°F)
    • dosing cup provided
  • Inactive ingredients

    citric acid, edetate disodium, ethylcellulose, FD&C yellow no. 6, 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

  • Questions?

    1-888-963-3382

    You may also report side effects to this phone number.

  • SPL UNCLASSIFIED SECTION

    Distributed by: Reckitt Benckiser, Parsippany, NJ 07054-0224

  • DELSYM (DEXTROMETHORPHAN) (DEXTROMETHORPHAN) SUSPENSION, EXTENDED RELEASE

    Label Image
  • INGREDIENTS AND APPEARANCE
    DELSYM (DEXTROMETHORPHAN) 
    dextromethorphan suspension, extended release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17856-0276(NDC:63824-177)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Dextromethorphan (UNII: 7355X3ROTS) (Dextromethorphan - UNII:7355X3ROTS) Dextromethorphan Hydrobromide30 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    Polistirex (UNII: 5H9W9GTW27)  
    citric acid monohydrate (UNII: 2968PHW8QP)  
    edetate disodium (UNII: 7FLD91C86K)  
    ethylcelluloses (UNII: 7Z8S9VYZ4B)  
    FD&C yellow no. 6 (UNII: H77VEI93A8)  
    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    Score    
    ShapeSize
    FlavorORANGEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:17856-0276-110 mL in 1 CUP; Type 0: Not a Combination Product05/04/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA01865808/19/2011
    Labeler - Atlantic Biologicals Corps (047437707)
    Registrant - Atlantic Biologicals Corps (047437707)
    Establishment
    NameAddressID/FEIBusiness Operations
    Atlantic Biologicals Corps047437707RELABEL(17856-0276) , REPACK(17856-0276)
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