Label: DEXTROMETHORPHAN POLISTIREX suspension, extended release

  • NDC Code(s): 58602-610-05, 58602-610-06
  • Packager: Aurohealth LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated May 4, 2026

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

View All Sections
  • Drug Facts

  • Active ingredient (in each 5 mL)

    Dextromethorphan polistirex equivalent to 30 mg dextromethorphan hydrobromide USP

  • 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 such as occurs with smoking, asthma, or emphysema
    • cough that occurs with too much phlegm (mucus)
  • STOP USE

    Stop use and ask a doctor if cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition.

  • PREGNANCY OR BREAST FEEDING

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

  • 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 (1-800-222-1222) 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 5 mg
    • store at 20º to 25°C (68º to 77°F)
    • dosing cup provided
  • Inactive ingredients

    citric acid anhydrous, edetate disodium, ethylcellulose, FD & C Yellow no. 6,  high fructose corn syrup, masker citrus flavour, methylparaben, polyethylene glycol, polysorbate 80, propylene glycol, purified water, sucrose, tragacanth, xanthan gum


  • Questions or comments?

    call 1-855-274-4122 (Monday – Friday 8:30 AM to 5:00 PM EST)


     Distributed by:
    AUROHEALTH LLC
    279 Princeton-Hightstown Road
    East Windsor, NJ 08520

    Made in India 

  • PRINCIPAL DISPLAY PANEL - 89 mL (3 fl oz) Bottle Label

    AUROHEALTH

    NDC 58602-610-05

    CHILDREN'S
    COUGH SUPPRESSANT
    Dextromethorphan Polistirex
    Extended-Release Oral Suspension
    30 mg/5 mL
    COUGH

    AGES 4+

    12 HOUR
    RELIEF

    CONTAINS
    NO FEVER REDUCER
    OR PAIN RELIEVER

    DAY or NIGHT
    ALCOHOL FREE

    Orange Flavored
    Liquid
    For Children & Adults

    89 mL (3 fl oz)




    PRINCIPAL DISPLAY PANEL - 89 mL (3 fl oz) Bottle Label
  • PRINCIPAL DISPLAY PANEL - 89 mL (3 fl oz) Bottle Carton Label

    NDC 58602-610-05

    Compare to Children's Delsym®
    active ingredient*
    AUROHEALTH
    CHILDREN'S
    COUGH SUPPRESANT
    Dextromethorphan Polistirex
    Extended-Release Oral Suspension
    30 mg/5 mL
    COUGH

    DAY or NIGHT
    Alcohol Free
    For Children & Adults

    AGES 4+

    12 HOUR
    RELIEF

    Orange Flavored
    Liquid

    89 mL (3 fl oz)


    PRINCIPAL DISPLAY PANEL - 89 mL (3 fl oz) Bottle Carton Label

  • INGREDIENTS AND APPEARANCE
    DEXTROMETHORPHAN POLISTIREX 
    dextromethorphan polistirex suspension, extended release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58602-610
    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)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    ETHYLCELLULOSE AQUEOUS DISPERSION TYPE B (UNII: HZJ2V81RYU)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SUCROSE (UNII: C151H8M554)  
    TRAGACANTH (UNII: 2944357O2O)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorORANGEScore    
    ShapeSize
    FlavorORANGEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58602-610-051 in 1 CARTON04/15/2026
    189 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
    2NDC:58602-610-061 in 1 CARTON04/15/2026
    2148 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21841704/15/2026
    Labeler - Aurohealth LLC (078728447)
    Establishment
    NameAddressID/FEIBusiness Operations
    APL HEALTHCARE LIMITED650918514ANALYSIS(58602-610) , MANUFACTURE(58602-610)
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!