Epi-mist
FDA Label NDC 15343-125

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Drnaturalhealing Inc for the product Epi-mist (NDC 15343-125). 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 ingredient, purpose, indications and usage, warning section, dosage and administration, how supplied, storage and handling, inactive ingredient section, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredient

ACTIVE INGREDIENT: Racepinephrine HCL, USP (1% Epinephrine)

Purpose

BRONCHODILATOR

Indications And Usage

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Warning Section

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Dosage And Administration

DIRECTIONS
• Do not take more than directed
• Place your lips around the mouthpiece and squeeze the bulb while inhaling simultaneously to breathe in the epinephrine aerosol– see figure below for details
• Adults and children 4 years of age and over: Do not take more than one dose every 3 hours. Do not take more than 8 doses in a 24-hour period. The use of this product by children under the age of 12 should be supervised by an adult.
• For children’s usage between 4 to 12 years of age: an adult may squeeze the bulb while your child inhales.
• Please contact your doctor if your symptoms advance.

How Supplied

HOW SUPPLIED

Each unit of EpiMist contains 10 ml, 250 doses of epinephrine. Each dose (40 microliters) is delivered by one (1) turn-click of the device, containing 1% epinephrine solution made with racepinephrine hydrogen chloride, USP.

Storage And Handling

STORAGE AND HANDLING
1) Protect from light to reduce loss of the activity of the active ingredient.
2) Avoid excessive heat.
3) You can carry the whole set during daytime but avoid excessive heat and bright light.
4) When at home, it is recommended to store in refrigerator (35 to 40 oF).
5) After the liquid medicine is used out, dispose the plastic device properly.

Inactive Ingredient Section

INACTIVE INGREDIENT
Water, Edetate Disodium, Ascorbic Acid, Citric Acid, Polysobate-60. All USP grade.

Keep Out Of Reach Of Children

KEEP OUT OF REACH OF CHILDREN
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away

Display Panel

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Epimist Main Panel Jpeg (Ada43ab1 6d9c 4707 B77b 905b81ef8705.jpeg Main)

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