DEXTROMETHORPHAN POLISTIREX suspension, extended release

Drug Labeling and Warnings

Drug Details [pdf]

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, D&C Red no.33, edetate disodium, ethylcellulose, FD & C Blue no. 1, FD & C Red no. 40, grape flavour,  high fructose corn syrup, 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

Code: AP/DRUGS/04/2016

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

AUROHEALTH

NDC: 58602-611-05

Children's
Dextromethorphan Polistirex
Extended-Release Oral Suspension
30 mg/5 mL
[Cough Suppressant]

COUGH

AGES 4+

12 HOUR
RELIEF

Contains
no Fever Reducer
or Pain Reliever

grape
Flavored Liquid
For Children & Adults

DAY or NIGHT
ALCOHOL FREE

89 mL (3 fl oz)              

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

AUROHEALTH

NDC: 58602-611-05

Compare to Children's Delsym®
active ingredient*

Children's
Dextromethorphan
Polistirex Extended-
Release Oral Suspension
30 mg/5 mL
[Cough Suppressant]

COUGH

AGES 4+

12 HOUR
RELIEF

grape
Flavored Liquid
For Children & Adults

DAY or NIGHT
ALCOHOL FREE

89 mL (3 fl oz)

INGREDIENTS AND APPEARANCE

DEXTROMETHORPHAN POLISTIREX 
dextromethorphan polistirex suspension, extended release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58602-611
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)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ETHYLCELLULOSE AQUEOUS DISPERSION TYPE B (UNII: HZJ2V81RYU)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GRAPE (UNII: 6X543N684K)
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)
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
Color	PURPLE (Purple to dark purple)	Score
Shape		Size
Flavor	GRAPE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58602-611-05	1 in 1 CARTON	04/15/2026
1		89 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
2	NDC: 58602-611-06	1 in 1 CARTON	04/15/2026
2		148 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA218417	04/15/2026

Labeler - Aurohealth LLC (078728447)

Establishment
Name	Address	ID/FEI	Business Operations
APL HEALTHCARE LIMITED		650918514	ANALYSIS(58602-611) , MANUFACTURE(58602-611)