Label: TRISPEC DMX PEDIATRIC DROPS COUGH SUPPRESSANT EXPECTORANT CHERRY RASPBERRY FLAVOR- dextromethorphan hydrobromide, guaifenesin liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated February 27, 2014

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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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