NDC 46017-329 Cold-eeze Daytime And Nighttime Quickmelts

Zinc Gluconate, Valerian, And Chamomile

NDC Product Code 46017-329

NDC Code: 46017-329

Proprietary Name: Cold-eeze Daytime And Nighttime Quickmelts What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Zinc Gluconate, Valerian, And Chamomile What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

NDC Code Structure

  • 46017 - Mylan Consumer Healthcare, Inc.
    • 46017-329 - Cold-eeze

NDC 46017-329-44

Package Description: 1 KIT in 1 CARTON * 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK * 18 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK

NDC Product Information

Cold-eeze Daytime And Nighttime Quickmelts with NDC 46017-329 is a a human over the counter drug product labeled by Mylan Consumer Healthcare, Inc.. The generic name of Cold-eeze Daytime And Nighttime Quickmelts is zinc gluconate, valerian, and chamomile. The product's dosage form is kit and is administered via form.

Labeler Name: Mylan Consumer Healthcare, Inc.

Dosage Form: Kit - A packaged collection of related material.

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.

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.

  • GLYCINE (UNII: TE7660XO1C)
  • MALIC ACID (UNII: 817L1N4CKP)
  • CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • MANNITOL (UNII: 3OWL53L36A)
  • MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
  • POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
  • SODIUM LAURYL SULFATE (UNII: 368GB5141J)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
  • STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)
  • SUCRALOSE (UNII: 96K6UQ3ZD4)
  • TALC (UNII: 7SEV7J4R1U)
  • MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
  • GLYCINE (UNII: TE7660XO1C)
  • MALIC ACID (UNII: 817L1N4CKP)
  • CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • MALTODEXTRIN (UNII: 7CVR7L4A2D)
  • MANNITOL (UNII: 3OWL53L36A)
  • MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
  • POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
  • SODIUM LAURYL SULFATE (UNII: 368GB5141J)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
  • STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)
  • SUCRALOSE (UNII: 96K6UQ3ZD4)
  • TALC (UNII: 7SEV7J4R1U)
  • MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)

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: 02-13-2019 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.

Cold-eeze Daytime And Nighttime Quickmelts Product Label Images

Cold-eeze Daytime And Nighttime Quickmelts 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 Tablet)

Zincum Gluconicum 1X

Purpose

Cold Remedy

Cold RemedySleep Disorder RemedyRelaxation and Calming

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

  • •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 •helps to relax and sleep easier to get rested

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

Stop Use And Ask Your Healthcare Practitioner

If symptoms persist beyond 7 daysCold-EEZE® QuickMelts® Daytime is formulated to reduce the duration of the common cold and its symptoms.It is insufficient treatment for Influenza or Allergies.

If symptoms persist beyond 7 daysCold-EEZE® Nighttime QuickMelts® is a combination product formulated to help you to sleep easier and to reduce the duration of the common cold and its symptoms. It is insufficient treatment for Influenza or Allergies.Allow 6-8 hours for sleep after taking tablet

If Pregnant Or Breastfeeding,

Ask a healthcare practitioner before use

Ask a healthcare practitioner before use

Directions

  • •Take Cold-EEZE® Daytime QuickMelts® when you have cold symptoms •Adults and children 12 years and over:oDissolve entire tablet in mouth. Do not chew. Do not swallow whole.oTake 1 tablet 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 tablets for adults and 4 tablets for ages 12-17 years •For children under 12 years of age, consult a healthcare practitioner before use

  • •Take Cold-EEZE® Nighttime QuickMelts® at night when you have cold symptoms •Adults:oDissolve entire tablet in mouth. Do not chew. Do not swallow whole.oTake 1 Nighttime tablet 1 hour before bedtimeoDo not eat or drink for 15 minutes after use, otherwise, drink plenty of fluidsoRecommended dose is 1 tablet for adults •For individuals under the age of 18, consult a healthcare practitioner before use

Other Information

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

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

Inactive Ingredients

Crospovidone, FD&C Red #40, glycine, magnesium stearate, malic acid, mannitol, microcrystalline cellulose, natural mixed berry flavor, natural menthol flavor, polyethylene glycol, silicon dioxide, sodium lauryl sulfate, sodium starch glycolate, stevia, sucralose, talc

  • Crospovidone, FD&C Blue #1 & #2, glycine, magnesium stearate, malic acid, maltodextrin, mannitol, microcrystalline cellulose, natural mixed berry flavor, natural menthol flavor, polyethylene glycol, sodium lauryl sulfate, silicon dioxide, sodium starch glycolate, stevia, sucralose, talcRelax & Sleep Natural Nighttime Formula:+Chamomile and Valerian to help you relax and fall asleep faster, naturally+Shortens your cold, works faster®+Natural Herbal Extracts+Gluten Free+Dissolves quickly in the mouth without water+Releases zinc ions in the mouth

Cold-Eeze® Nighttime Quickmelts® (Pm)

Drug Facts

Active Ingredients (Per Tablet)

Zincum Gluconicum 1XValeriana Officinalis 1XChamomile (Matricaria recutita) 2X

Ask A Doctor Before Using Cold-Eeze®

  • Nighttime QuickMelts® if you •are taking fluvoxamine (Luvox), minocycline, doxycycline, tetracycline or are on Coumadin therapy, as zinc treatment may inhibit the absorption of these medicines •are under medical supervision and/or are taking tranquilizers, sedatives or anti-seizure medicinesDo not use: •if taking loperamide •while operating a motor vehicle or machinery or consuming alcohol

In Case Of Overdose,

Get medical help or contact a poison control center right away.

* Please review the disclaimer below.

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