ROBO COUGH (DEXTROMETHORPHAN HBR) LIQUID [DXM PHARMACUETICAL, INC.]

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ROBO COUGH (DEXTROMETHORPHAN HBR) LIQUID [DXM PHARMACUETICAL, INC.]
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NDC 71598-000-00
Set ID 67ccc318-e73d-5b88-e053-2991aa0a0e4c
Category HUMAN OTC DRUG LABEL
Packager DXM Pharmacuetical, Inc.
Generic Name
Product Class
Product Number
Application Number PART341
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  • PURPOSE

    In each 3ml (one dose)

    Dextromethrophan HBr 30 mg......................cough suppressant

  • INDICATIONS & USAGE

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

  • WARNINGS

    ​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.

  • ASK DOCTOR

    Ask a doctor before use if you have

    • a cough that is accompanied by excessive phlegm (mucus), or
    • a persisten or chronic cough such as occurs with smoking, asthma, or emphysema.
  • STOP USE

    Stop use and ask a doctor if​ a 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.

  • PREGNANCY OR BREAST FEEDING

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

  • 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. (1-800-222-1222)

  • DOSAGE & ADMINISTRATION

    ​Directions

    • ​only use this product according to these directions or as directed by a doctor.
    • do not exceed 120 milligrams in any 24-hour period
    • measure only 3mL with dosing cup provided
    • keep dosing cup with product
    • mL= milliliter
    • this adult product is not intented for use in children under 12 years of age.

    age dose
    adults and children 12 years and over

    3mL every 6 to 8 hours
    children under 12 yearsdo not use

  • STORAGE AND HANDLING

    Other information

    • ​​store at 20-25* (68-77*F). Do not refigerate.
    • TAMPER EVIDENT: Do not use if printed shrink band on bottle is broken or missing.
  • INACTIVE INGREDIENT

    ​Inactive ingredients​ high fructose corn syrup, methyl antrhaniliate (artificial grape flavor), phosphoric acid, propylene glycol, purified water, sodium benzoate (preservative), sucralose

  • QUESTIONS

    ​Questions or comments?

    ​Call 1-833-289-7626 between 10 a.m. to 4 p.m. CST, Monday through Friday 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.

  • ACTIVE INGREDIENT

    Dextromethorphan HBr........30mg

  • PRINCIPAL DISPLAY PANEL

    Distributed by:

    DXM Pharmaceutical, Inc.

    2717 Commercial Center Blvd.,

    Suite E200

    Katy, TX 77494

    www.RoboCough.com

    Patent Pending. Copyright 2018 DXM Pharmaceutical, Inc.

    label

  • INGREDIENTS AND APPEARANCE
    ROBO COUGH 
    dextromethorphan hbr liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71598-000
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE30 mg  in 3 mL
    Inactive Ingredients
    Ingredient NameStrength
    HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
    PHOSPHORIC ACID (UNII: E4GA8884NN)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    METHYL ANTHRANILATE (UNII: 981I0C1E5W)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorGRAPEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71598-000-0045 mL in 1 BOTTLE; Type 0: Not a Combination Product03/19/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34103/19/2018
    Labeler - DXM Pharmacuetical, Inc. (080748277)
    Registrant - DXM Pharmaceutical, Inc. (080748277)
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