NDC 47682-458 Medique Coldeeze

Zinc Gluconate

NDC Product Code 47682-458

NDC 47682-458-73

Package Description: 25 LOZENGE in 1 BOX

NDC Product Information

Medique Coldeeze with NDC 47682-458 is a a human over the counter drug product labeled by Unifirst-first Aid Corporation. The generic name of Medique Coldeeze is zinc gluconate. The product's dosage form is lozenge and is administered via oral form.

Labeler Name: Unifirst-first Aid Corporation

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.

Medique Coldeeze 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 GLUCONATE 2 [hp_X]/1

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.

  • CORN SYRUP (UNII: 9G5L16BK6N)
  • GLYCINE (UNII: TE7660XO1C)
  • SUCROSE (UNII: C151H8M554)
  • HONEY (UNII: Y9H1V576FH)

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: Unifirst-first Aid Corporation
Labeler Code: 47682
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: 03-30-2011 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: 12-31-2020 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.

Medique Coldeeze Product Label Images

Medique Coldeeze 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 2x (13.3mg)

Purpose

Cold Remedy

Uses

  • To reduce the duration of the common coldreduces the severity of cold symptoms: cough, sore throat, nasal congestion, post nasal drip and/or hoarseness

Ask A Doctor Before Use If You Are

  • Taking minocycline, doxycycline, tetracycline or are on coumadin therapy, zinc treatment may inhibit the absorption of these medicines

Stop Use And Ask A Healthcare Professional If

Symptoms persist beyond 7 days.

If Pregnant Or Breast-Feeding,

Ask a healthcare professional before use.

Directions

  • Adults and children 12 years and overtake Cold-EEZE when you have cold symptomscompletely dissolve a Cold-EEZE® lozenge in mouth (do not chew)repeat every 2 - 4 hours as needed until all symptoms subsiderecommended daily dosage is 6 lozenges for adults and 4 lozenges for ages 12-17Children under 12 years of age should consult a healthcare professional prior to use.

Other Information

  • Do not take Cold-EEZE® lozenges on an empty stomach to avoid possible minor stomach upsetdo not eat or drink for 15 minutes after usestore in a cool dry place after opening; best if used within 6 months after openinggluten-freecontains no artificial colors or preservatives

Inactive Ingredients

Corn syrup, honey*, glycine, natural flavors, sucrose*may contain

* Please review the disclaimer below.