NDC 48433-107 Calcium Antacid

Calcium Carbonate

  1. Labeler Index
  2. Safecor Health, Llc
  3. NDC: 48433-107 Calcium Antacid

NDC Product Code 48433-107

NDC CODE: 48433-107

Proprietary Name: Calcium 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):
GRAY (C48324)
RED (C48326)
PURPLE (C48327)
ORANGE (C48331)
Shape: ROUND (C48348)
Size(s):
16 MM
Score: 1
Flavor(s):
LIME (C73398)
CHERRY (C73375)
ORANGE (C73406)
LEMON (C73396)

NDC Code Structure

  • 48433 - Safecor Health, Llc

NDC 48433-107-10

Package Description: 100 BLISTER PACK in 1 BOX, UNIT-DOSE > 1 TABLET, CHEWABLE in 1 BLISTER PACK (48433-107-01)

NDC Product Information

Calcium Antacid with NDC 48433-107 is a a human over the counter drug product labeled by Safecor Health, Llc. The generic name of Calcium Antacid is calcium carbonate. The product's dosage form is tablet, chewable and is administered via oral form.

Labeler Name: Safecor Health, Llc

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.

Calcium 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 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.
  • DEXTROSE (UNII: IY9XDZ35W2)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • MALTODEXTRIN (UNII: 7CVR7L4A2D)

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: Safecor Health, Llc
Labeler Code: 48433
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: 10-01-2014 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: 12-31-2021 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’.

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Information for Patients



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[Read More]
Calcium Carbonate

Calcium Carbonate is pronounced as (kal' see um) (kar' bon ate)
Why is calcium carbonate medication prescribed?
Calcium carbonate is a dietary supplement used when the amount of calcium taken in the diet is not enough. Calcium is needed by the body for healthy bones, muscles, nervo...
[Read More]

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Calcium Antacid Product Label Images

Calcium 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

Active Ingredient

Calcium Carbonate 750 mg

Purpose

Acid Indigestion, Heartburn, Sour & Upset Stomach

Uses

  • Relieves •heartburn •acid indigestion •sour stomach •upset stomach due to these symptoms

When Using

Do not take more than 10 tablets in a 24 hour period or use the maximum dosage of this product for more than two weeks.

Directions

  • •chew 2-4 tablets as symptoms occur, repeat hourly if needed

Other Information

  • •store at 59°-86°F •do not use if imprinted safety seal under cap is broken or missing •Calcium content per tablet: 300 mg

Supplement Facts

  • •Serving size 2 tablets •Servings per Container: 50 •Amount Per Serving Calories: 10 Calcium: 600 mg(60%DV)

Inactive Ingredients

Dextrose, FD&CBlue #1, FD&C Red #40, flavors, magnesium stearate, maltodextrin

Packaged And Distributed By:

Safecor Health, LLCWoburn, MA 01801

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