NDC 0363-1097 Walgreen Cherry Zinc Lozenges

Zinc Gluconate

NDC Product Code 0363-1097

NDC CODE: 0363-1097

Proprietary Name: Walgreen Cherry Zinc Lozenges 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 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):
WHITE (C48325 - SEMI-TRANSLUCENT)
Shape: OVAL (C48345)
Size(s):
22 MM
Imprint(s):
B
Score: 1
Flavor(s):
CHERRY (C73375)

NDC Code Structure

  • 0363 - Walgreen

NDC 0363-1097-25

Package Description: 25 LOZENGE in 1 BOX

NDC Product Information

Walgreen Cherry Zinc Lozenges with NDC 0363-1097 is a a human over the counter drug product labeled by Walgreen. The generic name of Walgreen Cherry Zinc Lozenges is zinc gluconate. The product's dosage form is lozenge and is administered via oral form.

Labeler Name: Walgreen

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.

Walgreen Cherry Zinc Lozenges 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

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.

  • 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: 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: 04-08-2021 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: 12-31-2022 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 - NO 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Walgreen Cherry Zinc Lozenges 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 lozenge)Zincum Gluconicum 2X (13.4mg)

Otc - Purpose

PurposeCold Relief

Indications & Usage

  • Usesmay help reduce the duration of common cold symptomsthis product was formulated to help reduce the duration and severity of cold symptoms and was not formulated to be effective for flu or allergies

Warnings

WarningsAsk a doctor before use if you have a sensitivity to zinc or are allergic to zinc or any of the other ingredients in this product.

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if you are taking minocycline, doxycycline, tetracycline or are on coumadin therapy; zinc treatment may inhibit the absorption of these medicines.

Otc - When Using

  • When using this productto avoid minor stomach upset, do not dissolve lozenges on an empty stomachavoid citrus fruits or juices and products containing citric acid 1/2 hour before or after taking, as they may diminish effectiveness

Otc - Stop Use

Stop use and ask a doctor if symptoms persist for more than 7 days or are accompanied by a fever.

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

  • Directionsadults and children 12 years and overfor best results, begin treatment at start of symptoms (within 24 - 48 hours of onset)completely dissolve lozenge in mouth. (Do not swallow whole. Do not chew.)repeat every 2 - 4 hours as needed until symptoms subsidedo not exceed 6 lozenges for adults and 4 lozenges for children ages 12 - 17 in a 24 hour periodfor children under 12 years of age, consult a health professional prior to use

Other Safety Information

  • Other informationnot formulated to be effective for treatment of influenza or allergiesstore in a cool dry place after openingno artificial colors or preservatives

Inactive Ingredient

Inactive ingredients: Corn starch, corn syrup, glycine, medium chain triglycerides, natural flavors, purified water, soybean oil and sucrose.

Otc - Questions

Questions? Or to report an adverse event call
1-800-245-2898. Monday - Friday, 9AM to 4PM EST

* Please review the disclaimer below.