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← See all Dextromethorphan Polistirex Extended-Release brands

Dextromethorphan Polistirex Extended-Release

Dosage form: suspension
Ingredients: DEXTROMETHORPHAN HYDROBROMIDE 30mg in 5mL
Labeler: Amneal Pharmaceuticals LLC
NDC Code: 65162-799

Dextromethorphan Polistirex Extended-release Suspension
12 Hour Cough Relief
Grape

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 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
  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
  • mL = milliliter

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
Bridgewater, NJ 08807

Rev. 06-2016-00

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DEXTROMETHORPHAN POLISTIREX EXTENDED-RELEASE 
dextromethorphan polistirex suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65162-799
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE30 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM POLYSTYRENE SULFONATE 
CITRIC ACID MONOHYDRATE 
CORN OIL 
D&C RED NO. 33 
EDETATE DISODIUM 
ETHYLCELLULOSES 
FD&C BLUE NO. 1 
METHYLPARABEN 
POLYETHYLENE GLYCOL 3350 
POLYSORBATE 80 
PROPYLENE GLYCOL 
PROPYLPARABEN 
WATER 
SUCROSE 
TRAGACANTH 
XANTHAN GUM 
HYDROCHLORIC ACID 
SODIUM HYDROXIDE 
Product Characteristics
ColorPURPLEScore    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:65162-799-761 BOTTLE in 1 CARTON
189 mL in 1 BOTTLE
2NDC:65162-799-771 BOTTLE in 1 CARTON
2148 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20313308/01/2017
Labeler - Amneal Pharmaceuticals LLC (831227777)
Establishment
NameAddressID/FEIOperations
Amneal Pharmaceuticals, LLC963900878ANALYSIS(65162-799), LABEL(65162-799), MANUFACTURE(65162-799), PACK(65162-799)

 
Amneal Pharmaceuticals LLC

← See all Dextromethorphan Polistirex Extended-Release brands

Medically reviewed on Aug 1, 2017

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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