Label: EMESYL PLUS- natrum sulphuricum, kali phosphoricum, ipicacuanha, taracum, zingiber officinale spray

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

Drug Label Information

Updated June 7, 2018

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active Ingredients 

    Natrum sulphuricum ... 5C
    Kali phosphoricum ..... 5C

    Ipecacuanha ............... 6C
    Tabacum..................... 6C
    Zingiber officinale ..... 1C

  • PURPOSE

    Purpose

    Well being

    Nausea symptom relief

  • INDICATIONS & USAGE

    Uses
    For moisturizing, well being and for the
    moderation of nausea and nausea like
    symptoms.

  • WARNINGS

    Warnings
    Safety sealed. Do not use if tamper resistant
    seal around the bottle is broken or missing.

    For nasal use only.

  • ASK DOCTOR

    Ask doctor before use if you have
    Ear, nose, or throat sensitivity. Susceptibility
    to nose bleeds.

  • WHEN USING

    When using this product
    Avoid contact with eyes. In case of
    accidental contact with eyes, flush with
    water and immediately seek professional
    help.

    The use of this container by more than one
    person may spread infection.

  • STOP USE

    Stop use and ask doctor if symptoms
    persist.

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health
    professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If
    swallowed, get medical help or contact a
    Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions
    ●See side panel for directions
    ●Shake before each use
    ●Pump one spray into each nostril. Use
      once every 4 hours.
    ●Wait at least 30 seconds before blowing
      nose.

  • INACTIVE INGREDIENT

    Inactive Ingredients
    Purified water USP, glycerin, hempseed
    (cannabis sativa) oil, sodium chloride,
    benzyl alcohol, sodium phosphate dibasic
    dihydrate, benzalkonium chloride,
    potassium chloride, potassium phosphate
    monobasic.

  • PRINCIPAL DISPLAY PANEL

    Emesyl Plus Box

    Emesyl Plus Botl

    EMESYL® PLUS
    PREMIUM HEMP Oil

    Nasal Use Only

    Do not use if safety seal is torn or open

    NDC 59067·002·01

    EMESYL® PLUS
    PREMIUM HEMP Oil
    NASAL SPRAY
    [Cannabis Sativa)

    EMESYL PLUS will help you to:
    ●Fortify your body and mind
    ●Target moderate changes in health
    ●Strengthen a foundation of overall wellness

    HOMEOPATHIC
    0.5 FL OZ (15mL)

    EMESYL® PLUS

    FORTIFY YOUR
    BODY AND MIND

    ► No known drug
        Interactions

    ► Non-drowsy

    ► No jitters

    ► Non-habit forming
       Homeopathic formulation

    Store at room
    temperature
    20°C - 25°C (68°F -77°F)

    Question? Comment?
    Call 1.800.687.1498 or
    visit us on the web at
    www.emesyl.com

    Manufactured for
    Itonis, Incorporated
    22951 Mill Creek Dr, Ste A
    Laguna Hills, CA 92653

    Certified
    cGMP
    ●current● Good Manufacturing Practices

    EMESYL® PLUS

    DIRECTIONS
    Shake before each use.

    1. Remove cap and safety tip.

    2. Hold with thumb at bottom
        of bottle and nozzle between
        your fingers.

    3. Prior to initial use, prime pump
        by holding it upright and depressing
        several times (into a tissue) until
        the liquid is dispensed.

    4. Place tip of nozzle just past nasal
        opening (approximately 1/8”).

    5. Pump one time into each nostril.
       Use once every 4 hours as needed.

    6. After application, press on the
        outside of each nostril for
        about 5 seconds.

    Drug Facts
    Active Ingredients(in each spray) Purpose

    Natrum sulphuricum 5C................... Well
    Kali phosphoricum 5C..................... being

    Ipecacuanha 6C........................... Nausea
    Tabacum 6C.:............................. symptom
    Zingiber officinale 1C..................... relief

    Uses
    For moisturizing, well being and for the
    moderation of nausea and nausea like
    symptoms.

    Warnings
    Safety sealed. Do not use if tamper resistant
    seal around the bottle is broken or missing.

    For nasal use only.

    Ask doctor before use if you have
    Ear, nose, or throat sensitivity. Susceptibility
    to nose bleeds.

    When using this product
    Avoid contact with eyes. In case of
    accidental contact with eyes, flush with
    water and immediately seek professional
    help.

    The use of this container by more than one
    person may spread infection.

    Stop use and ask doctor if symptoms
    persist.

    If pregnant or breast-feeding, ask a health
    professional before use.

    Keep out of reach of children. If
    swallowed, get medical help or contact a
    Poison Control Center right away.

    Directions
    ●See side panel for directions
    ●Shake before each use
    ●Pump one spray into each nostril. Use
      once every 4 hours.
    ●Wait at least 30 seconds before blowing
      nose.

    Inactive Ingredients
    Purified water USP, glycerin, hempseed
    (cannabis sativa) oil, sodium chloride,
    benzyl alcohol, sodium phosphate dibasic
    dihydrate, benzalkonium chloride,
    potassium chloride, potassium phosphate
    monobasic.

  • INGREDIENTS AND APPEARANCE
    EMESYL PLUS 
    natrum sulphuricum, kali phosphoricum, ipicacuanha, taracum, zingiber officinale spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59067-002
    Route of AdministrationNASAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM SULFATE (UNII: 0YPR65R21J) (SODIUM SULFATE ANHYDROUS - UNII:36KCS0R750) SODIUM SULFATE5 [hp_C]  in 15 mL
    DIBASIC POTASSIUM PHOSPHATE (UNII: CI71S98N1Z) (PHOSPHATE ION - UNII:NK08V8K8HR) DIBASIC POTASSIUM PHOSPHATE5 [hp_C]  in 15 mL
    IPECAC (UNII: 62I3C8233L) (IPECAC - UNII:62I3C8233L) IPECAC6 [hp_C]  in 15 mL
    TOBACCO LEAF (UNII: 6YR2608RSU) (TOBACCO LEAF - UNII:6YR2608RSU) TOBACCO LEAF6 [hp_C]  in 15 mL
    GINGER (UNII: C5529G5JPQ) (GINGER - UNII:C5529G5JPQ) GINGER1 [hp_C]  in 15 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    SODIUM PHOSPHATE DIBASIC DIHYDRATE (UNII: 94255I6E2T)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    POTASSIUM PHOSPHATE, MONOBASIC (UNII: 4J9FJ0HL51)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59067-002-011 in 1 PACKAGE06/01/2018
    115 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic06/01/2018
    Labeler - Itonis Inc. (829456545)
    Registrant - Itonis Inc. (829456545)
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