Dextromethorphan Polistirex Extended-release Suspension

Dextromethorphan Polistirex Extended-release Suspension
SPL v13
SPL
SPL Set ID ce7402d1-e48f-4bf1-90e9-cc57a52b35e5
Route
ORAL
Published
Effective Date 2024-06-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (30 mg)
Inactive Ingredients
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

Identifiers & Packaging

Pill Appearance
Color: orange
Marketing Status
ANDA Active Since 2017-08-01
Description

Drug Facts

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

Purpose

Purpose Cough suppressant

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

Medication Information

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
Purpose

Purpose Cough suppressant

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
Description

Drug Facts

Section 42229-5

Drug Facts

Warnings

Warnings

Otc Purpose

Purpose

Cough suppressant

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

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 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.

Inactive Ingredient

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 Active Ingredient

Active ingredient (in each 5 mL)

Dextromethorphan polistirex equivalent to 30 mg dextromethorphan hydrobromide, USP

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.

Package Label.principal Display Panel

Structured Label Content

Section 42229-5 (42229-5)

Drug Facts

Warnings (WARNINGS)

Warnings

Otc Purpose (OTC - PURPOSE)

Purpose

Cough suppressant

Otc Questions (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

Otc Ask Doctor (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 Do Not Use (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.

Inactive Ingredient (INACTIVE INGREDIENT)

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.

Indications and Usage (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
Otc Active Ingredient (OTC - ACTIVE INGREDIENT)

Active ingredient (in each 5 mL)

Dextromethorphan polistirex equivalent to 30 mg dextromethorphan hydrobromide, USP

Dosage and Administration (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
Otc Pregnancy Or Breast Feeding (OTC - PREGNANCY OR BREAST FEEDING)

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)

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:15.209615 · Updated: 2026-03-14T23:03:12.694901