Emesyl Nausea Relief
FDA Label NDC 59067-001

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Itonis, Inc. for the product Emesyl Nausea Relief (NDC 59067-001). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients, purpose, uses, warnings, ask a doctor before use if you have, when using this product, stop use and ask a doctor, if pregnant or breast feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Ipecacuanha 3C
Tabacum 3C
Zingiber officinale 1C

Purpose

Nausea symptom relief

Uses

For the symptomatic relief of nausea, and nausea like symptoms.

Warnings

For nasal use only

Ask A 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 A 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

  • Pump one or two times into each nostril. Use once every 4 hours as needed.
  • Adults and children 6 years of age and older (with adult supervision):
    • oRemove cap & safety clip (also see illustration on side carton & insert).
    • oHold with thumb at bottom of bottle and nozzle between your fingers.
    • oBefore using the first time, prime pump by depressing several times.
    • oPlace tip of nozzle just past nasal opening (approximately 1/8”).
    • oWhile inside nasal opening, slightly angle nozzle outward.
    • oPump one to two times into each nostril.
    • oAfter application, press lightly on outside of each nostril for about 5 seconds.
    • oWait at least 30 seconds before blowing nose.
    • oUse once every 4 hours
    • Children under 6 years of age: Consult a doctor before use.

Inactive Ingredients

benzalkonium chloride, glycerin, hydroxyethylcellulose, methyl paraben, purified water

Package/Label Principal Display Panel

Emesyl
Nausea Relief
Nasal Spray

Relief of:

  • Nausea
  • Nausea – like symptoms

    • 0.50 FL OZ (15mL) Homeopathic

    Take at the first signs of nausea symptoms

    • No known drug interactions
    • Non-drowsy
    • No jitters
    • Non-habit forming
    • Homeopathic

      • Distributed by:
      Itonis, Inc.
      22951 Mill Creek Dr.
      Suite A
      Laguna Hills, CA 92653

      Carton Label

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