NDC 57483-090 Aytumune

Zinc Acetate Anhydrous And Zinc Gluconate

NDC Product Code 57483-090

NDC CODE: 57483-090

Proprietary Name: Aytumune What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Zinc Acetate Anhydrous And Zinc Gluconate What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • This medication is used after other medications to treat a certain liver disease (Wilson's disease). This inherited disease causes the liver to hold onto too much copper, resulting in liver damage and other serious problems. This medication causes the intestines to make more of a certain substance (a protein) that prevents the body from absorbing too much copper from food, thereby preventing further damage.
  • Drug uses not available

NDC Code Structure

  • 57483 - Innovus Pharmaceuticals, Inc.

NDC 57483-090-43

Package Description: 1 BOTTLE in 1 CARTON > 30 mL in 1 BOTTLE

NDC Product Information

Aytumune with NDC 57483-090 is a a human over the counter drug product labeled by Innovus Pharmaceuticals, Inc.. The generic name of Aytumune is zinc acetate anhydrous and zinc gluconate. The product's dosage form is spray and is administered via oral form.

Labeler Name: Innovus Pharmaceuticals, Inc.

Dosage Form: Spray - A liquid minutely divided as by a jet of air or steam.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Aytumune Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • ZINC ACETATE 2 [hp_X]/mL
  • ZINC GLUCONATE 1 [hp_X]/mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • GLYCERIN (UNII: PDC6A3C0OX)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
  • WATER (UNII: 059QF0KO0R)
  • SUCRALOSE (UNII: 96K6UQ3ZD4)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Innovus Pharmaceuticals, Inc.
Labeler Code: 57483
Marketing Category: UNAPPROVED HOMEOPATHIC - What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 01-24-2021 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2022 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Aytumune Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredient

Zincum Aceticum 2xZincum Gluconicum 1x

Purpose

Reduces duration of a common cold

Uses

  • Reduces duration of a common coldReduces duration of cold symptoms:SneezingSore ThroatStuffy NoseCoughingCongestionAytuMune Oral Spray is formulated to reduce the duration of a common cold and may not  be effective for flu or allergies.

Warnings

For oral use only, not for use in nasal pathways.

When Using This Product

Avoid contact with the eyes. In case of accidental contact with eyes, flush with water and immediately seek professional help.

Ask A Doctor Before Use If You Have

A sensitivity to zinc or are allergic to zinc

Stop Use And Ask A Doctor If

Symptoms persist or if accompanied by fever.

If Pregnant Or Breastfeeding

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

• For best results, use at the first sign of a cold and continue to use for an additional 48 hours after symptoms subside.• Adults and children 12 years of age and older: o    Remove protective over-cap.o    Spray 4-5 times into mouth at the onset of symptoms.o    Spray on inside of cheeks, roof of mouth and gums. Retain for 15 seconds. Swallow.o    Repeat every three hours until symptoms are gone.o    To avoid minor stomach upset, do not take on an empty stomach.o    Do not eat or drink for 15 minutes after use. Do not eat or drink citrus fruits or juices for 30 minutes before or after use. Otherwise, drink plenty of fluids.• Children under 3 years of age, consult a doctor before use.

Other Information

Store between 15°C-29°C (59°F-84°F)

Inactive Ingredeints

Glycerin, Peppermint Flavor, Potassium Sorbate, Purified Water, Sucralose

* Please review the disclaimer below.