NDC 0135-0561 Tums Chewy Delights

Calcium Carbonate

NDC Product Code 0135-0561

NDC CODE: 0135-0561

Proprietary Name: Tums Chewy Delights 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.

NDC Code Structure

NDC 0135-0561-01

Package Description: 32 BAR, CHEWABLE in 1 BAG

NDC 0135-0561-02

Package Description: 6 BAR, CHEWABLE in 1 PACKAGE

NDC 0135-0561-03

Package Description: 2 BAR, CHEWABLE in 1 POUCH

NDC Product Information

Tums Chewy Delights with NDC 0135-0561 is a a human over the counter drug product labeled by Glaxosmithkline Consumer Healthcare Holdings (us) Llc. The generic name of Tums Chewy Delights is calcium carbonate. The product's dosage form is bar, chewable and is administered via oral form.

Labeler Name: Glaxosmithkline Consumer Healthcare Holdings (us) Llc

Dosage Form: Bar, Chewable - A solid dosage form usually in the form of a rectangle that is meant to be chewed.

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 Delights 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 1177 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.

  • STARCH, CORN (UNII: O8232NY3SJ)
  • CORN SYRUP (UNII: 9G5L16BK6N)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • ACACIA (UNII: 5C5403N26O)
  • HYDROGENATED COCONUT OIL (UNII: JY81OXM1OM)
  • COW MILK (UNII: 917J3173FT)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
  • SUCROSE (UNII: C151H8M554)

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: 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: 08-01-2013 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.

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]

* Please review the disclaimer below.

Tums Chewy Delights 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 (In Each Chew)

Calcium carbonate USP 1177 mg

Purpose

Antacid

Uses

  • Relieves: •heartburn •sour stomach •acid indigestion •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 chews in 24 hours •if pregnant, do not take more than 4 chews 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 and swallow 2-3 chews 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 chew contains: elemental calcium 470 mg, magnesium 5 mg •do not store above 25°C (77°F)

Inactive Ingredients (Smooth Peppermint)

Corn starch, corn syrup, corn syrup solids, FD&C blue #1, flavors, glycerin, gum arabic, hydrogenated coconut oil, non-fat dairy milk, potassium sorbate, propylene glycol, soy lecithin, sucrose

Inactive Ingredients (Very Cherry)

Corn starch, corn syrup, corn syrup solids, FD&C red #40 lake, flavors, glycerin, hydrogenated coconut oil, non-fat dairy milk, propylene glycol, soy lecithin, sucrose

Inactive Ingredients (Orange Rush)

Corn starch, corn syrup, corn syrup solids, FD&C yellow #6 lake, flavors, glycerin, hydrogenated coconut oil, modified food starch, non-fat dairy milk, propylene glycol, soy lecithin, sucrose

* Please review the disclaimer below.