Label: NASOPEN PE- phenylephrine hydrochloride, thonzylamine hydrochloride liquid

  • NDC Code(s): 58809-729-04
  • Packager: GM Pharmaceuticals, INC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 27, 2023

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  • SPL UNCLASSIFIED SECTION

    Nasopen PE

    NDC 58809-729-04

    Tamper evident by foil seal under cap.

    Do not use if foil seal is broken or missing.

    Supplied in a tight, light-resistant container with a child-resistant cap.

    Distributed by: GM Pharmaceuticals, Inc.

    Arlington, TX 76015

    Drug Facts

  • Active ingredients (in each 15 mL (TBSP))

    Phenylephrine HCl 10 mg

    Thonzylamine HCl 50 mg

  • Purpose

    Nasal Decongestant

    Antihistamine

  • Uses

    Temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:

    • nasal congestion
    • reduces swelling of the nasal passages
    • runny nose
    • sneezing
    • itching of the nose or throat
    • itchy, watery eyes
  • Warnings

    Do not exceed recommended dosage.

    Do not use this product

    • 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 the enlargement of the prostate gland
    • glaucoma
    • a breathing problem such as emphysema or chronic bronchitis

    Ask a doctor or pharmacist before use if you are

    taking sedatives or tranquilizers.

    When using this product

    • excitability may occur, especially in children
    • may cause drowsiness
    • avoid alcoholic drinks
    • alcohol, sedatives, and tranquilizers may increase the drowsiness effect
    • use caution when driving a motor vehicle or operating machinery

    Stop use and ask a doctor if

    • nervousness, dizziness, or sleeplessness occurs
    • symptoms do not improve within 7 days or accompanied by fever.
    • new symptoms occur

    If pregnant or breast-feeding,

    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

    • Do not exceed recommended dosage.
    • Use enclosed dosage cup or tablespoon (TBSP).
    Adults and children
    12 years of age
    and over:
    		15 mL (1 TBSP) every 4 hours,
    not to exceed 90 mL (6 TBSP) in a
    24 hour period.
    Children 6 to under
    12 years of age:
    		7.5 mL (1/2 TBSP) every 4 hours,
    not to exceed 45 mL (3 TBSP) in a
    24 hour period.
    Children under
    6 years of age:
    		Consult a doctor.
  • Other information

    • Each 15 mL (TBSP) contains: Sodium 6 mg.
    • Store at 59-86°F (15-30°C).
  • Inactive ingredients

    citric acid anhydrous, cotton candy flavor, FD&C Red #40, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate dihydrate, sorbitol, sucralose.

  • Questions? Comments?

    Call 1-888-535-0305   9 a.m. - 5 p.m. CST.

    R100716

  • PRINCIPAL DISPLAY PANEL

    NDC 58809-729-04
    NasOpenPE
    Cotton Candy Flavor
    4 fl.oz. (118 mL)

    PRINCIPAL DISPLAY PANEL NDC 58809-729-04 NasOpenPE Cotton Candy Flavor 4 fl.oz. (118 mL)

    PRINCIPAL DISPLAY PANEL NDC 58809-729-04 NasOpenPE Cotton Candy Flavor 4 fl.oz. (118 mL)

  • INGREDIENTS AND APPEARANCE
    NASOPEN  PE
    phenylephrine hydrochloride, thonzylamine hydrochloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58809-729
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg  in 15 mL
    THONZYLAMINE HYDROCHLORIDE (UNII: 6K9YKD48Y4) (THONZYLAMINE - UNII:R79646H5Z8) THONZYLAMINE HYDROCHLORIDE50 mg  in 15 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    MALTITOL (UNII: D65DG142WK)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorCOTTON CANDYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58809-729-04118 mL in 1 BOTTLE; Type 0: Not a Combination Product10/03/201211/30/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01210/03/201211/30/2024
    Labeler - GM Pharmaceuticals, INC (793000860)
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