TRISPEC DMX COUGH SUPPRESSANT EXPECTORANT PEACH FLAVOR (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) LIQUID [DELIZ PHARMACEUTICAL CORP]

  • Home
  • TRISPEC DMX COUGH SUPPRESSANT EXPECTORANT PEACH FLAVOR (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) LIQUID [DELIZ PHARMACEUTICAL CORP]

TRISPEC DMX COUGH SUPPRESSANT EXPECTORANT PEACH FLAVOR (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) LIQUID [DELIZ PHARMACEUTICAL CORP]
PDF | XML
NDC 58238-227-04
Set ID eee53314-655c-496b-bc01-1caa70cbf2b7
Category HUMAN OTC DRUG LABEL
Packager Deliz Pharmaceutical Corp
Generic Name
Product Class
Product Number
Application Number PART341
View All Sections
  • TRISPEC DMX Cough Suppressant Expectorant Peach 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 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 a doctor before use if you have

    • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
    • 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.
  • PREGNANCY OR BREAST FEEDING

    If pregnant or breastfeeding 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 Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions

    • use only with enclosed measuring cup
      • do not use enclosed measuring cup for any other drug product

        Adults and children

        12 years of age

        and older:

        2 teaspoonfuls (tsp) every 4 hours

        not to exceed 8 teaspoonfuls in

        24 hours, or as directed by a doctor.

        Children 6 to under

        12 years of age:

        1 teaspoonful (tsp) every 4 hours

        not to exceed 4 teaspoonfuls in

        24 hours, or as directed by a doctor.

        Children 2 to under

        6 years of age:

        ½ teaspoonful (tsp) every 4 hours

        not to exceed 2 teaspoonfuls in

        24 hours, or as directed by a doctor.

  • STORAGE AND HANDLING

    Other Information

    • Store at room temperature 15ºC-30ºC (59ºF-86ºF)
  • INACTIVE INGREDIENT

    Inactive Ingredients

    Bitter Mask, Citric Acid, Maltitol, Peach Flavor, Propylene Glycol, Purified Water, Sodium Citrate, Sorbitol, Sucralose

  • QUESTIONS

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

  • TRISPEC DMX COUGH SUPPRESSANT EXPECTORANT PEACH FLAVOR 4 OZ/118 ML (58238-227-04)

    Trispec DMX Labeling 1

    Trispec DMX Labeling 2

  • INGREDIENTS AND APPEARANCE
    TRISPEC DMX COUGH SUPPRESSANT EXPECTORANT PEACH FLAVOR 
    dextromethorphan hydrobromide, guaifenesin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58238-227
    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)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    MALTITOL (UNII: D65DG142WK)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorPEACHImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58238-227-041 in 1 PACKAGE11/18/2014
    1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34111/18/2014
    Labeler - Deliz Pharmaceutical Corp (826391138)
    Establishment
    NameAddressID/FEIBusiness Operations
    Woodfield Pharmaceutical, LLC079398730manufacture(58238-227)
View All Sections

Related Drugs

Search DailyMed Drugs