pilldic.Your medicine dictionary
Text size
← US medicines
US · Over-the-counter medicine

Dextromethorphan Polistirex Extended-Release

Dosage form
SUSPENSION
Labeler
Amneal Pharmaceuticals LLC
Label updated
2024-06-27
Retrieved
2026-09-07
Active ingredients
DEXTROMETHORPHAN HYDROBROMIDE
View original label and images on DailyMed ↗
Label information

Drug Facts

OTC - ACTIVE INGREDIENT

Active ingredient (in each 5 mL)

Dextromethorphan polistirex equivalent to 30 mg dextromethorphan hydrobromide, USP

OTC - PURPOSE

Purpose

Cough suppressant

INDICATIONS AND USAGE

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

Warnings

OTC - DO NOT USE

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.

OTC - ASK DOCTOR

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 and ask a doctor if cough lasts more than 7 days, cough 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 right away.

DOSAGE AND ADMINISTRATION

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 7 mg
  • store at 20° to 25°C (68° to 77°F)
  • dosing cup provided
INACTIVE INGREDIENT

Inactive ingredients

citric acid, corn oil, D&C Red No. 33, edetate disodium, ethylcellulose, FD&C Blue No. 1, flavors, methylparaben, polyethylene glycol 3350, polysorbate 80, propylene glycol, propylparaben, purified water, sodium polystyrene sulfonate, sucrose, tragacanth, xanthan gum

Hydrochloric acid or sodium hydroxide solution, if required, to adjust the pH.

OTC - QUESTIONS

Questions?

Call 1-877-835-5472, Mon through Fri 9AM to 5PM EST.  

Distributed by:
Amneal Pharmaceuticals LLC
Bridgewater, NJ 08807

Rev. 06-2024-01

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

[Image in the official label — see DailyMed source]

Label information

[Image in the official label — see DailyMed source]

DailyMed Set ID: e0104a59-0bc2-4401-8c14-7f28499dbac6 · Version 10
NDC: 65162-799