NDC 0135-0553 Tums Ultra
Calcium Carbonate Tablet, Chewable Oral

Product Information

What is NDC 0135-0553?

The NDC code 0135-0553 is assigned by the FDA to the product Tums Ultra which is a human over the counter drug product labeled by Glaxosmithkline Consumer Healthcare Holdings (us) Llc. The generic name of Tums Ultra is calcium carbonate. The product's dosage form is tablet, chewable and is administered via oral form. The product is distributed in a single package with assigned NDC code 0135-0553-01 72 tablet, chewable in 1 bottle . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information, RxNorm crosswalk and the complete product label.

NDC Product Code0135-0553
Proprietary Name 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.		Tums Ultra
Non-Proprietary Name 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.		Calcium Carbonate
Product Type 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.		Human Otc Drug
Dosage FormTablet, 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.
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.		Glaxosmithkline Consumer Healthcare Holdings (us) Llc
Labeler Code0135
FDA Application Number 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.		part331
Marketing Category 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.		OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.		03-01-2023
Listing Expiration Date 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.		12-31-2024
Exclude Flag 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". 		N
NDC Code Structure

What are the uses for Tums Ultra?


Product Characteristics

Color(s)WHITE (C48325 - OFF-WHITE)
YELLOW (C48330)
ORANGE (C48331)
RED (C48326)
ShapeROUND (C48348)
Size(s)19 MM
Score1
Flavor(s)TROPICAL FRUIT PUNCH (C73419)
STRAWBERRY (C73417 - STRAWBERRY-BANANA)
PINEAPPLE (C73409 - PINEAPPLE-ORANGE)
ORANGE (C73406 - MANDARIN ORANGE)

Product Packages

NDC Code 0135-0553-01

Package Description: 72 TABLET, CHEWABLE in 1 BOTTLE

Product Details

What are Tums Ultra Active Ingredients?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
  • CALCIUM CARBONATE 1000 mg/1 - Carbonic acid calcium salt (CaCO3). An odorless, tasteless powder or crystal that occurs in nature. It is used therapeutically as a phosphate buffer in hemodialysis patients and as a calcium supplement.

Tums Ultra Active Ingredients UNII Codes

NDC to RxNorm Crosswalk

What is RxNorm? RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

Tums Ultra Inactive Ingredients UNII Codes

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.

* Please review the disclaimer below.

Tums Ultra Product Label

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Label Table of Contents



Active Ingredient (Per Tablet)



Calcium carbonate 1000 mg


Purpose



Antacid


Uses



relieves

  • •heartburn
  • •acid indigestion
  • •sour stomach
  • •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. Chew or crush tablets completely before swallowing.
  • •do not take for symptoms that persist for more than 2 weeks unless advised by a doctor

Other Information



  • •each tablet contains: elemental calcium 400 mg, magnesium 10 mg
  • •store below 30°C (86°F)
  • •contains FD&C Yellow No. 5 (tartrazine) as a color additive

Inactive Ingredients



corn starch, crospovidone, dextrose, FD&C red #40 lake, FD&C yellow #5 (tartrazine) lake, FD&C yellow #6 lake, flavor, magnesium stearate, maltodextrin, sucrose, talc


Questions?



1-800-897-7535


Additional Information



Safety sealed – Do not use if printed inner seal beneath cap is missing or broken.

Trademarks owned or licensed by GSK.
Dist. by: GSK CH
Warren, NJ 07059

©2022 GSK or licensor.

Gluten-Free


Principal Display Panel



GOES TO WORK IN SECONDS!

CALCIUM CARBONATE
TUMS
ANTACID

Tropical
Fruit

72 CHEWABLE TABLETS

ULTRA
STRENGTH 1000

202113 Back Label
202112 Front Label


* Please review the disclaimer below.