Label: PECGEN 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 October 28, 2022

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  • Drug Facts

  • Active Ingredients (in each 5 mL tsp)

    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 occurring 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 • cough that occurs with too much phlegm (mucus) • a cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema

    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 get better within 7 days or are accompanied by fever • cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or 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. In case of accidental overdose, get medical help or contact a Poison Control Center right away.

  • Directions

    do not take more than 4 doses in any 24-hour period

    Adults and children 12 years of age and older

    2 teaspoonfuls (10 mL) 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 (5 mL) 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

    Consult a doctor

  • Other information

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

    • Tamper evident by foil seal under cap. Do not use if foil seal is broken or missing

  • Inactive ingredients

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

  • SPL UNCLASSIFIED SECTION

    Contains the same active ingredients as Tri​spec® PSE

    • SUGAR FREE • ALCOHOL FREE

    • DYE FREE • GLUTEN FREE

    GRAPE FLAVOR

    Manufactured in the USA for Kramer Novis. San Juan, PR 00917.

    Tel: (787) 767-2072  www.kramernovis.com

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

  • Packaging

    Pecgn-new

  • INGREDIENTS AND APPEARANCE
    PECGEN PSE COUGH SUPPRESSANT EXPECTORANT NASAL DECONGESTANT GRAPE FLAVOR 
    dextromethorphan hydrobromide, guaifenesin, pseudoephedrine hydrochloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52083-628
    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)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorGRAPE (Grape Flavor) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52083-628-16474 mL in 1 BOTTLE; Type 0: Not a Combination Product08/08/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34108/08/2014
    Labeler - Kramer Novis (090158395)
    Registrant - Kramer Novis (090158395)
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