Label: DELSYM- dextromethorphan suspension, extended release

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

Drug Label Information

Updated August 30, 2012

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • 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

    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)

    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, 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.

  • 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, polyethylene glycol 3350, polysorbate 80, propylene glycol, propylparaben, purified water, sucrose, tragacanth, vegetable oil, 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 ©RB 2011

    Additional barcode labeling by:
    Physicians Total Care, Inc.
    Tulsa, Oklahoma        74146

  • PRINCIPAL DISPLAY PANEL - 89 mL Bottle Carton

    NDC 54868-6003-0

    Delsym®

    Dextromethorphan Polistirex
    Extended-Release Suspension (Cough Suppressant)

    COUGH

    DAY
    OR
    NIGHT

    12
    HOUR
    COUGH RELIEF

    Orange
    Flavored Liquid

    89 mL (3 fl oz)

    Alcohol-free

    PRINCIPAL DISPLAY PANEL - 89 mL Bottle Carton
  • INGREDIENTS AND APPEARANCE
    DELSYM 
    dextromethorphan suspension, extended release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54868-6003(NDC:63824-175)
    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:54868-6003-01 in 1 CARTON
    189 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA01865803/13/2009
    Labeler - Physicians Total Care, Inc. (194123980)
    Establishment
    NameAddressID/FEIBusiness Operations
    Physicians Total Care, Inc.194123980relabel(54868-6003)
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