Label: DEXTROMETHORPHAN POLISTIREX EXTENDED-RELEASE- dextromethorphan polistirex suspension

  • NDC Code(s): 65162-799-76, 65162-799-77
  • Packager: Amneal Pharmaceuticals LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated December 18, 2023

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    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

    30 mg/5 mL 3oz Label

    30 mg/5 mL 3oz Carton
  • INGREDIENTS AND APPEARANCE
    DEXTROMETHORPHAN POLISTIREX EXTENDED-RELEASE 
    dextromethorphan polistirex suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65162-799
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE30 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM POLYSTYRENE SULFONATE (UNII: 1699G8679Z)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    CORN OIL (UNII: 8470G57WFM)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    ETHYLCELLULOSES (UNII: 7Z8S9VYZ4B)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SUCROSE (UNII: C151H8M554)  
    TRAGACANTH (UNII: 2944357O2O)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Product Characteristics
    ColorpurpleScore    
    ShapeSize
    FlavorGRAPEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65162-799-761 in 1 CARTON08/01/2017
    189 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:65162-799-771 in 1 CARTON08/01/2017
    2148 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20313308/01/2017
    Labeler - Amneal Pharmaceuticals LLC (123797875)
    Establishment
    NameAddressID/FEIBusiness Operations
    Amneal Pharmaceuticals, LLC963900878analysis(65162-799) , label(65162-799) , manufacture(65162-799) , pack(65162-799)