TRISPEC DMX PEDIATRIC DROPS COUGH SUPPRESSANT EXPECTORANT CHERRY RASPBERRY FLAVOR (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) LIQUID [DELIZ PHARMACEUTICAL CORP]

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  • TRISPEC DMX PEDIATRIC DROPS COUGH SUPPRESSANT EXPECTORANT CHERRY RASPBERRY FLAVOR (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) LIQUID [DELIZ PHARMACEUTICAL CORP]

TRISPEC DMX PEDIATRIC DROPS COUGH SUPPRESSANT EXPECTORANT CHERRY RASPBERRY FLAVOR (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) LIQUID [DELIZ PHARMACEUTICAL CORP]
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NDC 58238-229-02
Set ID 95f910b0-1bab-4826-868a-a9d0148f23c2
Category HUMAN OTC DRUG LABEL
Packager Deliz Pharmaceutical Corp
Generic Name
Product Class
Product Number
Application Number PART341
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  • TRISPEC DMX Pediatric Drops Cough Suppressant Expectorant CHERRY RASPBERRY Flavor


  • Active ingredients (in each 5 mL teaspoonful)

    Dextromethorphan HBr, USP 10 mg
    Guaifenesin, USP 187 mg

    Purpose

    Cough suppressant
    Expectorant

  • Uses

    • temporarily relieves cough due to minor throat and bronchial irritation occurring with a cold or inhaled irritants
    • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
  • Warnings


    Do not use


    in a child who is 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.

    Ask a doctor before use if the child has

    • persistent or chronic cough such as occurs with asthma
    • cough accompanied by excessive phlegm (mucus)

    Stop use and ask a doctor if

    • 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.

    Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center right away.

  • Directions

    • For children under 6 years of age, use enclosed dropper
    • do not use enclosed dropper for any other drug product
    Children 2 to under 6 years of age:
    		2.5 mL every 4 hours not to exceed 15 mL in 24 hours, or as directed by a doctor
    Children under 2 years of age:
    		Consult a doctor.
  • Other information

    • Store at room temperature 15°C-30°C (59°F-86°F)
  • Inactive ingredients

    cherry flavor, citric acid, glycerin, methylparaben, monoammonium glycyrrhizinate, potassium citrate, potassium sorbate, propylparaben, propylene glycol, purified water, raspberry flavor, sorbitol, sucralose

  • Questions?

    Call 1-787-701-3312. You may also report serious side effects to this phone number.

  • TRISPEC DMX Pediatric Drops Cough Suppressant Expectorant CHERRY RASPBERRY Flavor 2oz/60ml (58238-229-02)

    Trispec DMX 1Trispec DMX 2

  • INGREDIENTS AND APPEARANCE
    TRISPEC DMX PEDIATRIC DROPS COUGH SUPPRESSANT EXPECTORANT CHERRY RASPBERRY FLAVOR 
    dextromethorphan hydrobromide, guaifenesin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58238-229
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 5 mL
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN187 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)  
    POTASSIUM CITRATE (UNII: EE90ONI6FF)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorCHERRY, RASPBERRY (Cherry Raspberry Flavor) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58238-229-021 in 1 PACKAGE
    160 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34102/27/2014
    Labeler - Deliz Pharmaceutical Corp (826391138)
    Establishment
    NameAddressID/FEIBusiness Operations
    TG United Liquid, Inc.830980947manufacture(58238-229)
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