NDC 46017-342 Cold-eeze Plus Defense

Zinc Gluconate, Sambucus Nigra Flower, Rosa Canina Leaf, Echinacea Purpurea, And Avena Sativa Leaf Lozenge Oral

NDC Product Information

Cold-eeze Plus Defense with NDC 46017-342 is a human over the counter drug product labeled by Mylan Consumer Healthcare, Inc.. The generic name of Cold-eeze Plus Defense is zinc gluconate, sambucus nigra flower, rosa canina leaf, echinacea purpurea, and avena sativa leaf. The product's dosage form is lozenge and is administered via oral form.

Dosage Form: Lozenge - A solid preparation containing one or more medicaments, usually in a flavored, sweetened base which is intended to dissolve or disintegrate slowly in the mouth. A lollipop is a lozenge on a stick.

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.

Cold-eeze Plus Defense 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.


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.

Pharmacologic Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.


Product Labeler Information

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

Labeler Name: Mylan Consumer Healthcare, Inc.
Labeler Code: 46017
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: 06-12-2020 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

End Marketing Date: 10-31-2022 What is the End Marketing Date?
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.

Exclude Flag: N - NO 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Cold-eeze Plus Defense 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 (Per Lozenge)

Zincum Gluconicum 1X (22%)Sambucus nigra 1X (11%)Rosa Canina L. (Rose Hips) 2X (9%)Echinacea Purpurea 3X (44%)Avena Sativa L. 2X (14%)

Purpose

Cold RemedyPromotes Immune SupportHelps with General Debility and Fatigue

Uses

  • •to reduce the duration of the common cold •reduces the severity of cold symptoms: cough, sore throat, nasal congestion, post nasal drip and/or hoarseness •supports immune system health •helps with General Debility and Fatigue

Warnings, Ask A Doctor Before Use If You

  • •are taking minocycline, doxycycline, tetracycline or are on Coumadin therapy, as zinc treatment may inhibit the absorption of these medicines •are under medical supervision for diabetes or have multiple sclerosis (MS), rheumatoid arthritis (RA), or an auto-immune condition

Stop Use And Ask Your Healthcare Practitioner

If symptoms persist beyond 7 days.Cold-EEZE® Plus Defense Lozenge is a combination product formulated to help you to reduce the duration of common cold symptoms and promote the immune system health. It is insufficient treatment for Influenza or Allergies.

If Pregnant Or Breast Feeding,

Ask a healthcare practitioner before use.

Directions

  • •Take Cold-EEZE® Plus Defense Lozenges when you have cold symptoms •Adults:oDissolve entire lozenge in mouth. Do not chew. Do not swallow whole.oTake 1 lozenge at the onset of symptomsoRepeat every 2-4 hours as needed until all symptoms subsideoDo not eat or drink for 15 minutes after use, otherwise, drink plenty of fluidsoRecommended daily dose is 6 lozenges for adults and 4 lozenges for ages 12-17 years •For children under 12 years of age, consult a healthcare practitioner before use

Other Information

  • •Do not take Cold-EEZE® PLUS Defense lozenges on an empty stomach to avoid possible minor stomach upset •Store in a cool and dry place after opening

Inactive Ingredients

Corn syrup, glycine, natural colors, natural flavors and sucrose. No artificial colors or preservatives.

Other

*Based on unit sales of cold shortening, homeopathic zinc lozenges.Manufactured for:Mylan Consumer Healthcare, Inc.Morgantown, WV 26505 U.S.A.This product has no expiration date

* Please review the disclaimer below.