DEXTROMETHORPHAN POLISTIREX - dextromethorphan polistirex suspension, extended release 
Aurohealth LLC

----------

Drug Facts

Active ingredient (in each 5 mL)

Dextromethorphan polistirex equivalent to 30 mg dextromethorphan hydrobromide USP

Purpose

Cough suppressant

Uses

temporarily relieves

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

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.

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 (1-800-222-1222) right away.

Directions

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

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 58602-617-05

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

COUGH

12 HOUR
RELIEF

CONTAINS
NO FEVER REDUCER
OR PAIN RELIEVER

DAY or NIGHT
ALCOHOL FREE

Orange Flavored
Liquid

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 58602-617-05

Compare to Delsym®
active ingredient*

AUROHEALTH

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

COUGH

DAY or NIGHT
Alcohol Free

12 HOUR
RELIEF

Orange Flavored
Liquid

89 mL (3 fl oz)


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

DEXTROMETHORPHAN POLISTIREX 
dextromethorphan polistirex suspension, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58602-617
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:58602-617-051 in 1 CARTON04/17/2026
189 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
2NDC:58602-617-061 in 1 CARTON04/17/2026
2148 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21841704/17/2026
Labeler - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIBusiness Operations
APL HEALTHCARE LIMITED650918514ANALYSIS(58602-617) , MANUFACTURE(58602-617)

Revised: 5/2026
Document Id: 272bae8c-f800-4cec-bc9a-014123bb81a6
Set id: 0fb8cdfc-3fa0-4773-813a-04c82b003bdf
Version: 2
Effective Time: 20260513
 
Aurohealth LLC