Label: BUPROPIDEX- dextromethorphan hydrobromide tablet

  • NDC Code(s): 71598-200-15
  • Packager: DXM Pharmacuetical, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 28, 2023

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

  • Active ingredient

    (in each tablet) Dextromethrophan HBr 15 mg

  • Purpose

    Cough suppressant

  • Uses

    Temporarily relieves cough due to minor throat and bronchial irritation as may occur with the common cold.

  • Warning

    Do not useif 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.

    Ask a doctor before use ifyou have
    • a cough that is accompanied by excessive phlegm (mucus), or
    • a persistent or chronic cough such as occurs with smoking, asthma, or emphysema.

    Stop use and ask a doctor ifa cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.

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

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

  • KEEP OUT OF REACH OF CHILDREN

  • DOSAGE & ADMINISTRATION

    ​Directions

    • only use this product according to these directions or as directed by a doctor
    • do not exceed 8 tablets in any 24-hour period.
    • this adult product is not intended for use in children under 12 years of age.

    agedose
    adults and children 12 years and over

    take 2 tablets every 6 to 8 hours, as needed

    children under 12 yearsdo not use

  • Other information 

    • store at 20-25°C (68-77°F). Do not refrigerate.
    • TAMPER EVIDENT: Do not use if safety seal under child-resistant cap is broken or missing.

  • Inactive ingredients

    magnesium stearate, microcrystalline cellulose, sodium starch glycolate

  • Questions or comments?

    Call weekdays between 10 a.m. to 4 p.m. CST, at 833-289-7626 or visit our website www.RoboCough.com to report serious adverse events associated with the use of this product. Please call a doctor for medical advice.

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    DXM Pharmaceutical, Inc. 2717 Commercial Center Blvd., Suite E200
    Katy, TX 77 494

    Copyright 2023. Patent Pending. www.RoboCough.com.

  • Product label

    image description
  • INGREDIENTS AND APPEARANCE
    BUPROPIDEX 
    dextromethorphan hydrobromide tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71598-200
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE15 mg
    Inactive Ingredients
    Ingredient NameStrength
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize6mm
    FlavorImprint Code DEX
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71598-200-15200 in 1 BOTTLE; Type 0: Not a Combination Product12/01/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01312/01/2023
    Labeler - DXM Pharmacuetical, Inc. (080748277)
    Registrant - DXM Pharmacuetical, Inc. (080748277)