NDC 46017-341 Cold-eeze Homeopathic

Zinc Gluconate, Rosa Canina, Echinacea Purpurea

NDC Product Information

Cold-eeze Homeopathic with NDC 46017-341 is a a human over the counter drug product labeled by Mylan Consumer Healthcare, Inc.. The generic name of Cold-eeze Homeopathic is zinc gluconate, rosa canina, echinacea purpurea. The product's dosage form is chewable gel and is administered via oral form.

Labeler Name: Mylan Consumer Healthcare, Inc.

Dosage Form: Chewable Gel -

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 Homeopathic 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 1 [hp_X]/1
  • ROSA CANINA FRUIT 2 [hp_X]/1
  • ECHINACEA PURPUREA 1 [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.

  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
  • CORN SYRUP (UNII: 9G5L16BK6N)
  • GLYCINE (UNII: TE7660XO1C)
  • MALIC ACID (UNII: 817L1N4CKP)
  • PECTIN (UNII: 89NA02M4RX)
  • EUROPEAN ELDERBERRY (UNII: BQY1UBX046)
  • SUCROSE (UNII: C151H8M554)
  • TRICALCIUM PHOSPHATE (UNII: K4C08XP666)
  • TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)

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: 07-01-2019 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: 12-31-2021 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 Homeopathic Product Label Images

Cold-eeze Homeopathic 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 chewable gel)Zinc Gluconate 1X HPUS† (8.8%) (13.2 mg zinc)Rosa Canina (Rose Hips)2X HPUS† (1.0%)Echinacea Purpurea 1X HPUS† (0.02%)† The letters ‘HPUS’ indicates that the active ingredient is in the officialHomeopathic Pharmacopeia of the United States.

Purposes

Cold remedyPromotes immune support*Promotes immune support*

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*

Warnings

Do not use for treatment of influenza or allergies. This product is intended only to reduce theduration of the common cold and its 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 orare on Coumadin (warfarin) therapy. Zinc treatment may inhibit the absorption of these medicines

Stop Use And Ask Your Doctor If

Symptoms persist for more than 7 days

If Pregnant Or Breast Feeding,

Ask a healthcare professional before use.

Directions

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

Other Information

  • •each chewable gel contains: sodium 10mg •store at room temperature in a cool, dry place •do not expose to excessive heat for long periods of time

Inactive Ingredients

Citric acid, corn syrup, flavors, glycine, malic acid, pectin, sambucus nigra (european elder),sucrose, sugar, tricalcium phosphate, trisodium citrate dihydrate, water

* Please review the disclaimer below.