FDA.reportPublic FDA data

DEXTROMETHORPHAN POLISTIREX - Aurohealth LLC | APL HEALTHCARE LIMITED

Manufacturer
Aurohealth LLC | APL HEALTHCARE LIMITED
Effective date
2026-05-04
Label type
Human OTC Drug Label
Version
3
Source
full-release
Hydrated at
2026-06-01 01:57:42

Label at a glance#

ProductDEXTROMETHORPHAN POLISTIREX
Active ingredientDEXTROMETHORPHAN
Label structure14 sections

Indications and 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

Dosage and administration

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...

Label contents#

Full prescribing information#

Active ingredient (in each 5 mL)

OTC - ACTIVE INGREDIENT SECTION

Dextromethorphan polistirex equivalent to 30 mg dextromethorphan hydrobromide USP

Purpose

OTC - PURPOSE SECTION

Cough suppressant

Uses

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

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

OTC - ASK DOCTOR SECTION

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

OTC - STOP USE SECTION

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.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

  • 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

SPL UNCLASSIFIED SECTION

  • each 5 mL contains: sodium 5 mg
  • store at 20º to 25°C (68º to 77°F)
  • dosing cup provided

Inactive ingredients

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

AUROHEALTH

NDC 58602-611-05

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

Grape Flavored
Liquid

For Children & Adults

89 mL (3 fl oz)              


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

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 58602-611-05

 Compare to Children's Delsym®
active ingredient*

AUROHEALTH

CHILDREN'S
COUGH SUPPRESSANT

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

DAY or NIGHT
Alcohol Free
For Children & Adults

AGES 4+

 12 HOUR
 RELIEF

Grape Flavored
Liquid

89 mL (3 fl oz)


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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1373045dextromethorphan polistirex 30 MG in 5 mL 12HR Extended Release Oral SuspensionPSN3
137304512 HR dextromethorphan polistirex 6 MG/ML Extended Release SuspensionSCD3
1373045dextromethorphan polistirex (dextromethorphan HBr 30 MG) per 5 ML 12 HR Extended Release SuspensionSY3
1373045dextromethorphan polistirex 6 MG/ML 12 HR Extended Release SuspensionSY3

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58602-611-05DEXTROMETHORPHAN POLISTIREX1 in 1 CARTONSUSPENSION, EXTENDED RELEASE13
58602-611-05DEXTROMETHORPHAN POLISTIREX89 mL in 1 BOTTLESUSPENSION, EXTENDED RELEASE893
58602-611-06DEXTROMETHORPHAN POLISTIREX148 mL in 1 BOTTLESUSPENSION, EXTENDED RELEASE1483
58602-611-06DEXTROMETHORPHAN POLISTIREX1 in 1 CARTONSUSPENSION, EXTENDED RELEASE13

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58602-61158602-611-05, 58602-611-06

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
DEXTROMETHORPHAN7355X3ROTSACTIR
POLISTIREX5H9W9GTW27IACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
D&C RED NO. 339DBA0SBB0LIACT
EDETATE DISODIUM7FLD91C86KIACT
ETHYLCELLULOSE AQUEOUS DISPERSION TYPE BHZJ2V81RYUIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C RED NO. 40WZB9127XOAIACT
GRAPE6X543N684KIACT
HIGH FRUCTOSE CORN SYRUPXY6UN3QB6SIACT
METHYLPARABENA2I8C7HI9TIACT
POLYETHYLENE GLYCOL 600030IQX730WEIACT
POLYSORBATE 806OZP39ZG8HIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SUCROSEC151H8M554IACT
TRAGACANTH2944357O2OIACT
XANTHAN GUMTTV12P4NEEIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
22026-04-16monthly-update2026-06-03 18:00:39

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A218417-001DEXTROMETHORPHAN POLISTIREXDEXTROMETHORPHAN POLISTIREXEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORAL2026-04-15

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A218417-001DEXTROMETHORPHAN POLISTIREXEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORAL2026-04-1584e616aacf4f…
2026-08-18 06:07:402026-07A218417-001DEXTROMETHORPHAN POLISTIREXEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORAL2026-04-15caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218417-001DEXTROMETHORPHAN POLISTIREXEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORAL2026-04-15a50c72e98297…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DEXTROMETHORPHAN POLISTIREXDEXTROMETHORPHAN POLISTIREXAurohealth LLC759acdcd-d8d0-41d0-8b80-7f81fe196a9f2026-05-04WarningsExact identifier
ndc (package): 58602-611-05
ndc (package): 58602-611-06
ndc (product): 58602-611
ndc11 (package): 58602061105
ndc11 (package): 58602061106
spl id: e568400c-98ea-4f20-be34-1fb3e05bb72b
spl set id: 759acdcd-d8d0-41d0-8b80-7f81fe196a9f

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.