Active Ingredient (In Each 5 Ml)
Dextromethorphan polistirex equivalent to 30 mg dextromethorphan hydrobromide USP
Dextromethorphan Polistirex Suspension, Extended Release
FDA Label NDC 58602-618
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 58602-618). 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
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, 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 Principal Display Panel (89 mL (3 fl oz) Bottle Label)
NDC 58602-618-05
Dextromethorphan Polistirex
Extended-Release Oral Suspension
30 mg/5 mL
[Cough Suppressant]
COUGH
12 HOUR
RELIEF
Contains
no Fever Reducer
or Pain Reliever
grape
Flavored Liquid
DAY or NIGHT
ALCOHOL FREE
89 mL (3 fl oz) 
Principal Display Panel - 89 Ml (3 Fl Oz) Bottle Carton Label
AUROHEALTH Principal Display Panel (89 mL (3 fl oz) Bottle Carton Label)
NDC 58602-618-05
Compare to Delsym®
active ingredient*
Dextromethorphan
Polistirex Extended-
Release Oral Suspension
30 mg/5 mL
[Cough Suppressant]
COUGH
12 HOUR
RELIEF
grape
Flavored Liquid
DAY or NIGHT
ALCOHOL FREE
89 mL (3 fl oz) 
* Please review the disclaimer below.
