Dextromethorphan Polistirex Suspension, Extended Release
FDA Label NDC 58602-610

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Aurohealth Llc for the product Dextromethorphan Polistirex (NDC 58602-610). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient (in each 5 ml), purpose, uses, warnings, ask a doctor before use if you have, otc - stop use, otc - pregnancy or breast feeding, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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)

Otc - 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.

Otc - Pregnancy Or Breast Feeding

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

Otc - 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 20° to 25°C (68° 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

Code: AP/DRUGS/04/2016

Principal Display Panel - 89 Ml (3 Fl Oz) Bottle Label

AUROHEALTH

NDC 58602-610-05

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

orange
Flavored Liquid
For Children & Adults

DAY or NIGHT
ALCOHOL FREE

89 mL (3 fl oz)


Principal Display Panel (89 mL (3 fl oz) Bottle Label)

Principal Display Panel (89 mL (3 fl oz) Bottle Label)

Principal Display Panel - 89 Ml (3 Fl Oz) Bottle Carton Label

AUROHEALTH

NDC 58602-610-05

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

orange
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)

Principal Display Panel (89 mL (3 fl oz) Bottle Carton Label)

* Please review the disclaimer below.