Label: ACTISPEC PSE- dextromethorphan hydrobromide, guaifenesin, pseudoephedrine hydrochloride solution

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated July 17, 2025

If you are a consumer or patient please visit this version.

  • Drug Facts

  • Active ingredients (in each 5 mL tsp)

    Dextromethorphan HBr 10 mg

    Guaifenesin 187 mg

    Pseudoephedrine HCl 30 mg

  • Purpose

    Cough Suppressant
    Expectorant
    Nasal Decongestant

  • Uses

    • temporarily relieves cough due to minor throat and bronchial irritation associated 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 enlargement of the prostate gland • cough accompanied by excessive phlegm (mucus) • persistent or chronic cough such occurs with smoking, asthma, chronic bronchitis or emphysema.

    Ask a doctor or pharmacist before use if you are taking any other oral nasal decongestant or stimulant.

    When using this product do not use more than directed.

    Stop use and ask a doctor if • nervousness, dizziness or sleeplessness occur • symptoms do not improve within 7 days or are accompanied by fever • cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or a persistent headache. These could be signs of a serious condition.

    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.

  • Directions

    do not exceed more than 6 doses in any 24-hour period.

     AGE DOSE
    Adults and children 12 years of age and over Take 2 teaspoonfuls (10 mL) every 4 hours
    Children 6 to under 12 years of age Take 1 teaspoonful (5 mL) every 4 hours
    Children under 6 years of age Ask physician

  • Other information

    • Tamper evident feature: Do not use if inner seal is torn, cut, or opened.

    • Store at controlled room temperature 15° - 30°C (59° - 86°F).

    • Avoid excessive heat or humidity.

  • Inactive ingredients

    citric acid, grape flavor, methylparaben, monoammonium glycyrrhizinate, potassium citrate, propylene glycol, propylparaben, purified water, sorbitol, sucralose

  • Questions or comments?

    call weekdays from 8 AM to 4PM AST at 1.787.608.0882.

  • SPL UNCLASSIFIED SECTION

    Contains the same active ingredients as Trispec® PSE*

    Alcohol FREE

    Dye FREE

    Sugar FREE

    Grape Flavor

    Manufactured in USA with imported ingredients for ActiPharma LLC. San Juan, PR 00917. www.actipharma.net. Rev. 04/25

    * Trispec® PSE is a registered trademark of Deliz Pharmaceutical Corp. This product is not manufactured, distributed or marketed by Deliz Pharmaceutical Corp.

  • Packaging

    ACTISPEC PSE

  • INGREDIENTS AND APPEARANCE
    ACTISPEC PSE 
    dextromethorphan hydrobromide, guaifenesin, pseudoephedrine hydrochloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63102-120
    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)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)  
    POTASSIUM CITRATE (UNII: EE90ONI6FF)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorgrapeImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63102-120-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product07/17/2025
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01207/17/2025
    Labeler - ACTIPHARMA, LLC (079340948)