NDC 67060-122 Advanced Homeopathic Cold-eeze

Zincum Gluconicum 2x

NDC Product Code 67060-122

NDC 67060-122-39

Package Description: 25 PACKET in 1 CARTON > 1 LOZENGE in 1 PACKET (67060-122-01)

NDC Product Information

Advanced Homeopathic Cold-eeze with NDC 67060-122 is a a human over the counter drug product labeled by Advanced First Aid, Inc.. The generic name of Advanced Homeopathic Cold-eeze is zincum gluconicum 2x. The product's dosage form is lozenge and is administered via oral form.

Labeler Name: Advanced First Aid, Inc.

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.

Advanced Homeopathic Cold-eeze 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)

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: Advanced First Aid, Inc.
Labeler Code: 67060
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: 09-16-2019 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.

Advanced Homeopathic Cold-eeze Product Label Images

Advanced Homeopathic Cold-eeze 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

Otc - Active Ingredient

Active Ingredient (in each tablet) - Zincum Gluconicum 2x (13.3mg)

Otc - Purpose

Homeopathic cold remedy

Indications & Usage

  • Uses:reduce the duration of the common coldreduce the severity of cold symptoms: cough, sore throat, stuffy nose, sneezing, post nasal drip and/or hoarseness

Warnings

  • Warnings:Cold-Eeze lozenges are formulated to reduce the duration of common cold smptoms and may be insufficient treatment for influenza or allergies.Ask a doctor before use if you:are taking monocycline, tetracycline, doxycycline or are on coumadin therapy, zinc treatment may inhibit the absorption of these medications.Stop use and ask a doctor if:symptoms persist beyond 7 days

Otc - Pregnancy Or Breast Feeding

If pregnant or breastfeeding, ask a healthcare professional before use.

Dosage & Administration

  • Directions:adults and children 12 years and overfor best results, begin treatment at start of symptoms (within 24-48 hours of onset)repeat ever 2-4 hours as needed until all symptoms subsidecompletely dissolve lozenge in mouth (do not chew)recommended daily dosage is 6 lozenges for adults and 4 lozenges for ages 12-17

Other Safety Information

  • To avoid minor stomach upset, do not dissolve lozenge on an empty stomachdo not eat or drink for 15 minutes after usestore in a cool dry place after opening

Inactive Ingredient

Inactive Ingredients: corn syrup, glycine, natural flavors and sucrose. No artificial colors or preservatives.

* Please review the disclaimer below.