Label: TRISPEC PSE COUGH SUPPRESSANT EXPECTORANT NASAL DECONGESTANT GRAPE FLAVOR- dextromethorphan hydrobromide, guaifenesin, pseudoephedrine hydrochloride 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 November 2, 2021

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  • Drug Facts

  • Active ingredients (in each 5 mL teaspoonful)

    Dextromethorphan HBr, USP 10 mg
    Guaifenesin, USP 187 mg
    Pseudoephedrine HCl, USP 30 mg

    Purpose

    Cough suppressant

    Expectorant

    Nasal decongestant

  • Uses

    • temporarily relieves cough due to minor throat and bronchial irritation occuring with a cold or inhaled irritants
    • helps loosen phlegm and thin bronchial secretions to make coughs more productive
    • temporarily relieves nasal congestion
  • 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

    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes
    • difficulty in urination due to enlarged prostate gland
    • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
    • cough accompanied by excessive phlegm (mucus)

    _____________________________________________________________________________________________

    When using this product

    • do not exceed recommended dosage

    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.
    • symptoms do not improve within 7 days or are acompanied by fever
    • nervousness, dizziness, or sleeplessness occur

    If pregnant or breastfeeding

    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.

  • 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.

  • Other Information

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

    Bitter Mask, Citric Acid, Glycerin, Grape Flavor, Propylene Glycol, Purified Water, Sodium Citrate, Sodium Saccharin, Sorbitol

  • Questions?

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

  • Product Labels

    Trispec PSE Labeling 1

    Trispec PSE Labeling 2

  • INGREDIENTS AND APPEARANCE
    TRISPEC PSE COUGH SUPPRESSANT EXPECTORANT NASAL DECONGESTANT GRAPE FLAVOR 
    dextromethorphan hydrobromide, guaifenesin, pseudoephedrine hydrochloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58238-228
    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
    PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE30 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorGRAPE (Grape Flavor) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58238-228-041 in 1 CARTON03/20/2015
    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 finalpart34103/20/2015
    Labeler - Deliz Pharmaceutical Corp (826391138)
    Establishment
    NameAddressID/FEIBusiness Operations
    Woodfield Pharmaceutical, LLC079398730manufacture(58238-228)
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