NDC 21130-310 Ultra Strength

Calcium Carbonate

NDC Product Code 21130-310

NDC CODE: 21130-310

Proprietary Name: Ultra Strength 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):
RED (C48326)
YELLOW (C48330)
ORANGE (C48331)
GREEN (C48329)
Shape: ROUND (C48348)
Size(s):
19 MM
Imprint(s):
RP103
Score: 1
Flavor(s):
FRUIT (C73389 - ASSORTED)

NDC Code Structure

NDC 21130-310-60

Package Description: 160 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC

NDC 21130-310-72

Package Description: 72 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC

NDC Product Information

Ultra Strength with NDC 21130-310 is a a human over the counter drug product labeled by Better Living Brands Llc. The generic name of Ultra Strength is calcium carbonate. The product's dosage form is tablet, chewable and is administered via oral form.

Labeler Name: Better Living Brands 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.

Ultra Strength 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 1000 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.

  • ADIPIC ACID (UNII: 76A0JE0FKJ)
  • D&C RED NO. 27 (UNII: 2LRS185U6K)
  • D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
  • DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • MALTODEXTRIN (UNII: 7CVR7L4A2D)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • SUCRALOSE (UNII: 96K6UQ3ZD4)

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.
  • 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: Better Living Brands Llc
Labeler Code: 21130
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: 09-30-2020 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’.

* Please review the disclaimer below.

Ultra Strength 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 (Per Tablet)

Calcium Carbonate USP 1,000mg

Purpose

Antacid

Uses

  • Relieves •heartburn •sour stomach •acid indigestion •upset stomach associated with these symptoms

Warnings

  • Ask a doctor or pharmacist before use if you are presently taking a prescription drug. Antacids may interact with certain prescription drugs.When using this product •do not take more than 7 tablets in 24 hours •if pregnant do not take more than 5 tablets in 24 hours •do not use the maximum dosage for more than 2 weeks except under the advice and supervision of a doctor.

Directions

  • •adults and children 12 years of age and over: chew 2-3 tablets as symptoms occur, or as directed by a doctor •do not take for symptoms that persist for more than 2 weeks unless advised by a doctor

Other Information

  • •each tablet contains: elemental calcium 400mg •store at room temperature. Keep the container tightly closed

Inactive Ingredients

Adipic acid, D&C Red No. 27 Lake, D&C Yellow No.10 Lake, dextrose, FD&C Blue No. 1 Lake, FD&C Yellow No. 6, flavor, magnesium stearate, maltodextrin, starch, sucralose.

* Please review the disclaimer below.