NDC 0135-0630 Tums Chewy Bites

Calcium Carbonate

NDC Product Code 0135-0630

NDC 0135-0630-01

Package Description: 60 TABLET, CHEWABLE in 1 CONTAINER

NDC Product Information

Tums Chewy Bites with NDC 0135-0630 is a 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.

Labeler Name: Glaxosmithkline Consumer Healthcare Holdings (us) 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.

Tums Chewy Bites 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

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: Glaxosmithkline Consumer Healthcare Holdings (us) Llc
Labeler Code: 0135
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: 03-01-2019 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: 12-31-2020 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.

Tums Chewy Bites 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 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

* Please review the disclaimer below.

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