NDC 62750-085 Zicam Cold Remedy Medicated Fruit Drops

Zinc Acetate Anhydrous, Zinc Gluconate, And Sambucus Nigra Flowering Top

NDC Product Code 62750-085

NDC Code: 62750-085

Proprietary Name: Zicam Cold Remedy Medicated Fruit Drops 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 Acetate Anhydrous, Zinc Gluconate, And Sambucus Nigra Flowering Top 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

  • 62750 - Matrixx Initiatives, Inc.
    • 62750-085 - Zicam Cold Remedy Medicated Fruit Drops

NDC 62750-085-10

Package Description: 25 BAR, CHEWABLE in 1 BOTTLE

NDC Product Information

Zicam Cold Remedy Medicated Fruit Drops with NDC 62750-085 is a a human over the counter drug product labeled by Matrixx Initiatives, Inc.. The generic name of Zicam Cold Remedy Medicated Fruit Drops is zinc acetate anhydrous, zinc gluconate, and sambucus nigra flowering top. The product's dosage form is bar, chewable and is administered via oral form.

Labeler Name: Matrixx Initiatives, Inc.

Dosage Form: Bar, Chewable - A solid dosage form usually in the form of a rectangle that is meant to be chewed.

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.

Zicam Cold Remedy Medicated Fruit Drops 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 ACETATE ANHYDROUS 2 [hp_X]/1
  • ZINC GLUCONATE 2 [hp_X]/1
  • SAMBUCUS NIGRA FLOWERING TOP 4 [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.

  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • CORN SYRUP (UNII: 9G5L16BK6N)
  • DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)
  • ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)
  • SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • MALIC ACID (UNII: 817L1N4CKP)
  • MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
  • PECTIN (UNII: 89NA02M4RX)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
  • SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)
  • SUCRALOSE (UNII: 96K6UQ3ZD4)
  • 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: Matrixx Initiatives, Inc.
Labeler Code: 62750
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: 07-20-2019 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.

Zicam Cold Remedy Medicated Fruit Drops Product Label Images

Zicam Cold Remedy Medicated Fruit Drops 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

Other

Drug Facts

Distributed by MatrixxInitiatives, Inc., Scottsdale, AZ85260

Otc - Purpose

Active ingredients (in each medicated drop)PurposeZincum aceticum 2xZincum gluconicum 2xReduces duration and severity of the common coldSambucus nigra (elderberry) 4xHelps relieve cold symptoms Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Uses

  • Reduces duration of the common coldhelps reduce severity of cold symptoms:sore throatstuffy nosesneezingcoughingnasal congestionZicam® Cold Remedy was formulated to shorten the duration of the common cold and was not formulated to be effective for flu or allergies.

Otc - Ask Doctor

Ask a doctor before use if you have a sensitivity to zinc or are allergic to zinc

Otc - Stop Use

Stop use and ask a doctor if symptoms persist or are accompanied by a fever or new symptoms occur

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

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

Directions

  • For best results, use at the first sign of a cold and continue to use until symptoms completely subsideadults and children 12 years of age and older:take one medicated drop at onset of symptomschew slowly and dissolve completely before swallowingrepeat every 2 – 3 hours, not to exceed 7 medicated drops in 24 hours. Take until symptoms are gone.to avoid minor stomach upset, do not take on an empty stomachdo not eat or drink for 15 minutes after use. Do not eat or drink citrus fruits or juices for 30 minutes before or after use. Otherwise, drink plenty of fluids.children under 12 years of age: ask a doctor before use

Other Information

  • Store between 15-29°C (59-84°F)avoid freezing and excessive heat

Inactive Ingredients

Citric acid, corn syrup, dextrose, dicalcium phosphate, disodium phosphate, FD&C Blue #1, FD&C Red #40, malic acid, menthol, natural flavors, pectin, purified water, sodium citrate, sodium polyphosphate, sucralose, sucrose

* Please review the disclaimer below.

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