NDC 0363-1093 Antacid Berry Bites

Calcium Carbonate

NDC Product Code 0363-1093

NDC Code: 0363-1093

Proprietary Name: Antacid Berry Bites 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: Calcium Carbonate 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):
PINK (C48328)
Shape: ROUND (C48348)
Size(s):
14 MM
Imprint(s):
FC
Score: 1
Flavor(s):
STRAWBERRY (C73417)

NDC Code Structure

  • 0363 - Walgreen
    • 0363-1093 - Antacid Berry Bites

NDC 0363-1093-32

Package Description: 32 TABLET, CHEWABLE in 1 BOTTLE

NDC Product Information

Antacid Berry Bites with NDC 0363-1093 is a a human over the counter drug product labeled by Walgreen. The generic name of Antacid Berry Bites is calcium carbonate. 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.

Antacid Berry Bites 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.

  • CALCIUM CARBONATE 750 mg/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
FDA Application Number: part331 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. 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: 02-18-2019 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.

Antacid Berry Bites 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)Calcium carbonate 750 mg

Otc - Purpose

PurposeAntacid

Indications & Usage

  • Uses Relieves
  • HeartburnSour stomachAcid indigestionUpset stomach due to these symptoms

Warnings

WarningsDo not use if you have ever had an allergic reaction to this product or any of its ingredients.

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if you are now taking a prescription drug. Antacids may interact with certain prescription drugs.

Otc - When Using

Do not take more than 5 chewable tablets in a 24-hour period, or use the maximum dosage for more than 2 weeks, except under the advice and supervision of a physician.When using this product constipation may 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

Directions Adults and children 12 years and older chew and swallow 1 to 2 chewable tablets every 2-4 hours as needed. Do not exceed 5 chewable tablets in 24 hours. Children under 12 years consult a doctor.

Other Safety Information

  • Other informationeach chewable tablet contains: calcium 300 mg
  • Contains soyStore between 20° to 25°C (68° to 77°F) in a dry place

Inactive Ingredient

Inactive ingredients: Beeswax, carmine, carnauba wax, citric acid, corn starch, corn syrup, ethyl acetate, FD&C blue no. 1 aluminum lake, FD&C red no. 40 aluminum lake, FD&C yellow no. 6 aluminum lake, gum arabic, hydrogenated coconut oil, maltodextrin, medium chain triglycerides, modified corn starch, natural and artificial flavors, phosphoric acid, pregelatinized corn starch, propylene glycol, purified water, shellac, sodium benzoate, sorbic acid, sorbitol, soy lecithin, soybean oil, sucrose and titanium dioxide.

Otc - Questions

Questions? Call
1-800-245-2898

* Please review the disclaimer below.

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