NDC 0363-1095 Walgreens Medicated Fruit Gummies

Zincum Aceticum Zicum Gluconicum

NDC Product Code 0363-1095

NDC Code: 0363-1095

Proprietary Name: Walgreens Medicated Fruit Gummies 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: Zincum Aceticum Zicum Gluconicum 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.

Product Characteristics

Color(s):
RED (C48326 - RED AND DEEP DARK BLUE)
Shape: ROUND (C48348)
Size(s):
24 MM
Imprint(s):
RD
Score: 1
Flavor(s):
CHERRY (C73375 - BLACK CHERRY AND BLUEBERRY POMEGRANATE)

NDC Code Structure

  • 0363 - Walgreen
    • 0363-1095 - Walgreens Medicated Fruit Gummies

NDC 0363-1095-25

Package Description: 25 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC

NDC Product Information

Walgreens Medicated Fruit Gummies with NDC 0363-1095 is a a human over the counter drug product labeled by Walgreen. The generic name of Walgreens Medicated Fruit Gummies is zincum aceticum zicum gluconicum. The product's dosage form is tablet, chewable and is administered via oral form.

Labeler Name: Walgreen

Dosage Form: Tablet, Chewable - A solid dosage form containing medicinal substances with or without suitable diluents that is intended to be chewed, producing a pleasant tasting residue in the oral cavity that is easily swallowed and does not leave a bitter or unpleasant after-taste.

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.

Walgreens Medicated Fruit Gummies 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 2 [hp_X]/1
  • 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.

  • WATER (UNII: 059QF0KO0R)

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: Walgreen
Labeler Code: 0363
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: 03-29-2019 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.

Walgreens Medicated Fruit Gummies 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 chewable tablet)Zincum aceticum 2xZincum gluconicum 2x

Otc - Purpose

PurposeReduces nasal congestion and duration of the common cold

Indications & Usage

  • Usesreduces duration of the common coldreduces nasal congestion

Warnings

WarningsAsk a doctor or pharmacist 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 few 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.

Dosage & Administration

  • Directionsfor best results, use at the first sign of a cold and continue until symptoms completely subsideAdults and children 12 years and older take one medicated drop at onset of symptoms. Chew slowly and dissolve completely in mouth every 3 hours until symptoms are gone. To avoid minor stomach upset, do not take on an empty stomach. Do not eat or drink for 15 minutes before or after use. Otherwise, drink plenty of fluids.Children under 12 years of age: ask a doctor before use

Other Safety Information

  • Other informationStore between 15° to 29° C (59° to 84°F) in a dry placeAvoid freezing and excessive heat

Inactive Ingredient

Inactive ingredients: Citric acid, corn syrup, dextrose, dicalcium phosphate, disodium diphosphate, FD&C blue #1, FD&C red #40, malic acid, medium chain triglycerides, natural flavors, pectin, sodium citrate, sodium polyphosphate, sucralose, sucrose and water.

Otc - Questions

Questions? Call
1-800-245-2898

* Please review the disclaimer below.

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