NDC 0135-0631 Tums Chewy Bites
Calcium Carbonate Tablet, Chewable Oral

Product Information

Product Code0135-0631
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 Chewy Bites
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.
03-01-2019
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.
12-31-2022
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

Usage Information


Product Packages

NDC 0135-0631-01

Package Description: 32 TABLET, CHEWABLE in 1 CONTAINER

Product Details

Tums Chewy Bites is a human over the counter drug product labeled by Glaxosmithkline Consumer Healthcare Holdings (us) Llc. The generic name of Tums Chewy Bites is calcium carbonate. The product's dosage form is tablet, chewable and is administered via oral form.


What are Tums Chewy Bites Active Ingredients?

The following is the list of active ingredients in this product. 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.


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:


Pharmacologic Class(es)

A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.


* Please review the disclaimer below.

Tums Chewy Bites Labeling and Warnings

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.

Table of Contents



Active Ingredient (Per Tablet)



Calcium Carbonate USP 750mg


Purpose



Antacid


Uses



relieves

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

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 6 tablets in 24 hours
  • •if pregnant do not take more than 6 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 2-4 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 chewable tablet contains: elemental calcium 300mg
  • •do not store above 25°C (77°F)

Inactive Ingredients



Acacia gum, alcohol, ammonium hydroxide, beeswax, carmine, carnauba wax, citric acid, coconut oil, corn starch, corn syrup, dextrin, ethyl acetate, ethyl alcohol, FD&C blue #1 alum lake, FD&C blue #2 alum lake, FD&C red #40 alum lake, FD&C yellow #6 alum lake, flavors, gum arabic, isopropyl alcohol, maltodextrin, methylparaben, n-butyl alcohol, phosphoric acid, propylparaben, propylene glycol, purified water, shellac, sorbic acid, sorbitol, soybean oil, soy lecithin, sucrose, TBHQ, titanium dioxide, vegetable oil


Questions?



Call 1-800-897-7535


Principal Display Panel



NDC 0135-0618-01

TUMS®

CALCIUM CARBONATE

ANTACID

Chewy Bites

Mixed Berry

NEW

GOES TO WORK IN SECONDS!

EXTRA STRENGTH 750

2 CHEWABLE TABLETS

Safety sealed : Do not use if packet is damaged or open.

Distributed by:

GSK Consumer Healthcare

Warren, NJ 07059

Trademarks are owned by or licensed to the GSK group of companies.

©2016 GSK or its licensor

105902XA


* Please review the disclaimer below.