TRISPEC PSE PEDIATRIC DROPS COUGH SUPPRESSANT EXPECTORANT NASAL DECONGESTANT GRAPE FLAVOR (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [DELIZ PHARMACEUTI

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  • TRISPEC PSE PEDIATRIC DROPS COUGH SUPPRESSANT EXPECTORANT NASAL DECONGESTANT GRAPE FLAVOR (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [DELIZ PHARMACEUTI

TRISPEC PSE PEDIATRIC DROPS COUGH SUPPRESSANT EXPECTORANT NASAL DECONGESTANT GRAPE FLAVOR (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [DELIZ PHARMACEUTI
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NDC 58238-230-02
Set ID b4630613-c78c-4f97-bd6c-0476899f5b90
Category HUMAN OTC DRUG LABEL
Packager Deliz Pharmaceutical Corp
Generic Name
Product Class alpha-Adrenergic Agonist
Product Number
Application Number PART341
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  • Drug Facts


  • Active ingredients (in each 5 mL)

    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 (mucus) 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
    • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
    • cough accompanied by excessive phlegm (mugus)

    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

    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:
    		2½ mL every 4 hours not to exceed 10 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

    Bitter Mask, Citric Acid Anhydrous, 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.

  • TRISPEC PSE Pediatric Drops Cough Suppressant Expectorant Nasal Decongestant GRAPE Flavor 2oz/59ml (58238-230-02)

    Trispec PSE Pediatric Drops Labeling 1

    Trispec PSE Pediatric Drops Labeling 2

  • INGREDIENTS AND APPEARANCE
    TRISPEC PSE PEDIATRIC DROPS COUGH SUPPRESSANT EXPECTORANT NASAL DECONGESTANT GRAPE FLAVOR 
    dextromethorphan hydrobromide, guaifenesin, pseudoephedrine hydrochloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58238-230
    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
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorGRAPE (Grape Flavor) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58238-230-021 in 1 CARTON02/27/2014
    160 mL in 1 BOTTLE; Type 0: Not a Combination Product
    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
    Woodfield Pharmaceutical, LLC079398730manufacture(58238-230)
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