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Delsym (Physicians Total Care, Inc.)

Available Formats

Dosage Form Package Information Links
SUSPENSION, EXTENDED RELEASE 1 BOTTLE in 1 CARTON (54868-6003-0) > 89 mL in 1 BOTTLE Label Information

Complete Delsym Information

  • 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 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

  • 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 Type HUMAN OTC DRUG Item Code (Source) NDC:54868-6003(NDC:63824-175)
    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)  
    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     
    Shape Size
    Flavor ORANGE Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:54868-6003-0 1 in 1 CARTON
    1 89 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA018658 03/13/2009
    Labeler - Physicians Total Care, Inc. (194123980)
    Establishment
    Name Address ID/FEI Business Operations
    Physicians Total Care, Inc. 194123980 relabel(54868-6003)