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

  • NDC Code(s): 63824-177-63, 63824-177-65
  • Packager: RB Health (US) LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated April 8, 2024

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

View All Sections
  • 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 useif 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 such as occurs with smoking, asthma, or emphysema
    • cough that occurs with too much phlegm (mucus)

    Stop use and ask a doctor ifcough lasts more than 7 days, 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
    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?

    1-866-682-4639

    You may also report side effects to this phone number.

  • SPL UNCLASSIFIED SECTION

    Distributed by: RB Health (US), Parsippany, NJ 07054-0224

  • PRINCIPAL DISPLAY PANEL - 148 mL Bottle Carton

    NDC 63824-177-65
    Ages 4+

    Children's
    Delsym ®

    Dextromethorphan Polistirex
    Extended-Release Suspension (Cough Suppressant)

    COUGH

    Day
    or
    Night

    12
    HOUR
    COUGH RELIEF     ™

    Orange
    Flavored Liquid

    148 mL (5 fl oz)
    For Children & Adults

    PRINCIPAL DISPLAY PANEL - 148 mL Bottle Carton
  • INGREDIENTS AND APPEARANCE
    DELSYM (DEXTROMETHORPHAN) 
    dextromethorphan suspension, extended release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)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)  
    ETHYLCELLULOSE, UNSPECIFIED (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:63824-177-631 in 1 CARTON08/19/2011
    189 mL in 1 BOTTLE; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)
    2NDC:63824-177-651 in 1 CARTON07/01/201710/03/2024
    2148 mL in 1 BOTTLE; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA01865808/19/2011
    Labeler - RB Health (US) LLC (081049410)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!