NDC 49314-1023 Unishield Antacid

Calcium Carbonate

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  3. NDC: 49314-1023 Unishield Antacid

NDC Product Code 49314-1023

NDC CODE: 49314-1023

Proprietary Name: Unishield Antacid 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.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.
  • This medication is used to treat symptoms caused by too much stomach acid such as heartburn, upset stomach, or indigestion. It is an antacid that works by lowering the amount of acid in the stomach. Check the ingredients on the label even if you have used the product before. The manufacturer may have changed the ingredients. Also, products with similar names may contain different ingredients meant for different purposes. Taking the wrong product could harm you.

Product Characteristics

Color(s):
WHITE (C48325)
Shape: ROUND (C48348)
Size(s):
12 MM
Imprint(s):
FR;8
Score: 1
Flavor(s):
MINT (C73404 - PEPPERMINT)

NDC Code Structure

  • 49314 - Unishield

NDC 49314-1023-3

Package Description: 50 PACKET in 1 BOX > 2 TABLET, CHEWABLE in 1 PACKET

NDC Product Information

Unishield Antacid with NDC 49314-1023 is a a human over the counter drug product labeled by Unishield. The generic name of Unishield Antacid is calcium carbonate. The product's dosage form is tablet, chewable and is administered via oral form.

Labeler Name: Unishield

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.

Unishield Antacid 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 420 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.
  • ACACIA (UNII: 5C5403N26O)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • MALTODEXTRIN (UNII: 7CVR7L4A2D)
  • 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: Unishield
Labeler Code: 49314
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: 03-01-2021 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.

Unishield Antacid Product Label Images

Unishield Antacid 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

Otc - Active Ingredient

Active ingredient (in each tablet)Calcium Carbonate 420 mg

Otc - Purpose

PurposeAntacid

Indications & Usage

UsesFor the relief of the following symptoms■ acid indigestion■ sour stomach■ heartburn■ upset stomach associated with these symptoms

Warnings

Warnings

Otc - Do Not Use

Do not use■ the maximum dosage of this product for more than 2 weeks except under the advice and supervision of a

physician or take more than 19 tablets in a 24 hour period.

Otc - Ask Doctor/Pharmacist

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

Otc - Stop Use

Stop use and ask a doctor if■ symptoms last more than 2 weeks

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 the reach of children.

Dosage & Administration

Directions■
do not use more than directed■ chew or crush tablets completely before swallowing■ do not swallow tablets wholeAdults and children: (12 years and older) Chew 2 tablets every 2 or 3 hours as symptoms occur or as

directed by a physician. Do not exceed 19 tablets in 24 hours.
Children under 12 years: Do not give to children under 12 years of age.

Other Safety Information

Other information■ phenylketonurics: may contain phenylalanine 1.5 mg per tablet■ each tablet contains 168 mg of elemental calcium■ store at room temperature 59-86ºF (15-30ºC) in a dry place■ tamper-evident sealed packets■ do not use any opened or torn packets

Inactive Ingredient

I
nactive ingredientsaspartame*, croscarmellose sodium*, gum acacia*, magnesium stearate, maltodextrin, mineral oil*, mint flavor, sorbitol*, sucrose**may contain

Otc - Questions

Questions or comments? 1-800-480-5855

* Please review the disclaimer below.