Dextromethorphan Polistirex Extended-Release

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Drug Facts

OTC - ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each 5 mL)

Dextromethorphan polistirex equivalent to 30 mg dextromethorphan hydrobromide, USP

OTC - PURPOSE

OTC - PURPOSE SECTION

Purpose

Cough suppressant

INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

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 SECTION

Warnings

OTC - DO NOT USE

OTC - DO NOT USE 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.

OTC - ASK DOCTOR

OTC - ASK DOCTOR SECTION

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN

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 right away.

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

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 INGREDIENT SECTION

Inactive ingredients

citric acid, corn oil, edetate disodium, ethylcellulose, FD&C Yellow No. 6, flavor, 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

OTC - QUESTIONS SECTION

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

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Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

• Dextromethorphan Polistirex Extended-Release
• Dextromethorphan Polistirex
• DEXTROMETHORPHAN HYDROBROMIDE
• DEXTROMETHORPHAN
• CITRIC ACID MONOHYDRATE
• CORN OIL
• EDETATE DISODIUM
• ETHYLCELLULOSES
• FD&C YELLOW NO. 6
• METHYLPARABEN
• POLYETHYLENE GLYCOL 3350
• POLYSORBATE 80
• PROPYLENE GLYCOL
• PROPYLPARABEN
• WATER
• SUCROSE
• TRAGACANTH
• XANTHAN GUM
• HYDROCHLORIC ACID
• SODIUM HYDROXIDE
• SODIUM POLYSTYRENE SULFONATE

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Ingredients#

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

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