Dextromethorphan Polistirex Extended-Release DEXTROMETHORPHAN POLISTIREX AMNEAL PHARMACEUTICALS LLC FDA Approved 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
FunFoxMeds box
Route
ORAL
Applications
ANDA203133

Drug Facts

Composition & Profile

Active Ingredients
OTC - ACTIVE INGREDIENT Active ingredient (in each 5 mL) Dextromethorphan polistirex equivalent to 30 mg dextromethorphan hydrobromide USP
Inactive Ingredients
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.
Strengths
5 ml 30 mg
Quantities
5 ml
Treats Conditions
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
Pill Appearance
Color: purple

Identifiers & Packaging

Container Type BOX
UNII
9D2RTI9KYH
Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 30 mg/5 mL 3oz Label 30 mg/5 mL 3oz Carton

Package Descriptions
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 30 mg/5 mL 3oz Label 30 mg/5 mL 3oz Carton

Overview

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

Indications & 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

Dosage & 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

Warnings & Precautions
WARNINGS Warnings
Purpose

OTC - PURPOSE Purpose Cough suppressant

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.

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.

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


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