NDC 46017-343 Cold-eeze Plus Cold And Flu Symptom Relief

Zinc Gluconate, Sambucus Nigra Flower, And Glycyrrhiza Glabra Leaf

NDC Product Information

Cold-eeze Plus Cold And Flu Symptom Relief with NDC 46017-343 is a a human over the counter drug product labeled by Mylan Consumer Healthcare, Inc.. The generic name of Cold-eeze Plus Cold And Flu Symptom Relief is zinc gluconate, sambucus nigra flower, and glycyrrhiza glabra leaf. The product's dosage form is lozenge and is administered via oral form.

Labeler Name: Mylan Consumer Healthcare, 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.

Cold-eeze Plus Cold And Flu Symptom Relief 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
  • SAMBUCUS NIGRA FLOWER 2 [hp_X]/1
  • GLYCYRRHIZA GLABRA LEAF 3 [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: 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.

Listing Expiration Date: 12-31-2021 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.

Cold-eeze Plus Cold And Flu Symptom Relief Product Label Images

Cold-eeze Plus Cold And Flu Symptom Relief 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 Ingredients (Per Lozenge)

Zinc Gluconate 2X HPUS† (2.22%) (13.3 mg zinc)Sambucus Nigra 2X HPUS† (1.0%)Glycyrrhiza Glabra (Licorice) 3X HPUS† (0.1%)†The letters ‘HPUS’ indicates that the active ingredient is in the official Homeopathic Pharmacopeia of the United States.

Purposes

Cold RemedyRelieves cough, nasal congestion and irritated respiratory tract*Relieves irritated throat*

Uses

  • •reduces the duration of the common cold •reduces the severity of cold symptoms: cough, sore throat, nasal congestion, post nasal drip and/or hoarseness •temporarily relieves cough, nasal congestion, irritated respiratory tract and sore throat associated with colds and flu*

Warnings

Do not use for treatment of influenza or allergies. This product is intended only to reduce the duration of the common cold and provide relief of cold and flu symptoms.

Ask A Doctor Before Use If You Have

  • •diabetes •multiple sclerosis (MS) • rheumatoid arthritis (RA) or other auto-immune condition

Ask A Doctor Or Pharmacist Before Use If You Are

Taking minocycline, doxycycline, tetracycline or are on Coumadin (warfarin) therapy. Zinc treatment may inhibit the absorption of these medicines.

When Using This Product

Do not take on an empty stomach (to avoid possible minor stomach upset).

Stop Use And Ask Your Doctor If

Symptoms persist beyond 7 days

If Pregnant Or Breastfeeding,

Ask a healthcare practitioner before use.

Keep Out Of Reach Of Children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

  • •take one lozenge at the onset of symptoms •do not swallow whole •dissolve entire lozenge in mouth •do not eat or drink for 15 minutes after use •do not chew •repeat every 2-4 hours until symptoms subsideAdults 18 years and overdo not exceed 6 lozenges per dayChildren 12 to under 18 yearsdo not exceed 4 lozenges per dayChildren under 12 yearsask a doctor before use

Other Information

  • •store in a cool, dry place after opening •best if used within 6 months after opening

Inactive Ingredients

Corn syrup, glycine, natural colors, natural flavors and sucrose

Other

This product has not been evaluated by the FDA. *Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.No artificial colors or preservatives

* Please review the disclaimer below.