NDC 0135-0624 Tums Chewy Bites With Gas Relief

Calcium Carbonate And Simethicone

NDC Product Code 0135-0624

NDC CODE: 0135-0624

Proprietary Name: Tums Chewy Bites With Gas Relief 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 And Simethicone 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.
  • This medication is used as a moisturizer to treat or prevent dry, rough, scaly, itchy skin and minor skin irritations (e.g., diaper rash, skin burns from radiation therapy). Emollients are substances that soften and moisturize the skin and decrease itching and flaking. Some products (e.g., zinc oxide, white petrolatum) are used mostly to protect the skin against irritation (e.g., from wetness). Dry skin is caused by a loss of water in the upper layer of the skin. Emollients/moisturizers work by forming an oily layer on the top of the skin that traps water in the skin. Petrolatum, lanolin, mineral oil and dimethicone are common emollients. Humectants, including glycerin, lecithin, and propylene glycol, draw water into the outer layer of skin. Many products also have ingredients that soften the horny substance (keratin) that holds the top layer of skin cells together (e.g., urea, alpha hydroxy acids such as lactic/citric/glycolic acid, and allantoin). This helps the dead skin cells fall off, helps the skin keep in more water, and leaves the skin feeling smoother and softer.

Product Characteristics

Color(s):
RED (C48326 - RED, YELLOW)
Shape: ROUND (C48348)
Size(s):
19 MM
Imprint(s):
T
Score: 1
Flavor(s):
STRAWBERRY (C73417 - STRAWBERRY, LEMON)

NDC Code Structure

  • 0135 - Glaxosmithkline Consumer Healthcare Holdings (us) Llc

NDC 0135-0624-01

Package Description: 28 TABLET, CHEWABLE in 1 BOTTLE

NDC 0135-0624-02

Package Description: 54 TABLET, CHEWABLE in 1 BOTTLE

NDC Product Information

Tums Chewy Bites With Gas Relief with NDC 0135-0624 is a a human over the counter drug product labeled by Glaxosmithkline Consumer Healthcare Holdings (us) Llc. The generic name of Tums Chewy Bites With Gas Relief is calcium carbonate and simethicone. 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 With Gas Relief 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
  • DIMETHICONE 80 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.

  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • ALCOHOL (UNII: 3K9958V90M)
  • AMMONIA (UNII: 5138Q19F1X)
  • YELLOW WAX (UNII: 2ZA36H0S2V)
  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
  • CARNAUBA WAX (UNII: R12CBM0EIZ)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • COCONUT OIL (UNII: Q9L0O73W7L)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • CORN SYRUP (UNII: 9G5L16BK6N)
  • ICODEXTRIN (UNII: 2NX48Z0A9G)
  • ETHYL ACETATE (UNII: 76845O8NMZ)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
  • FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
  • ACACIA (UNII: 5C5403N26O)
  • ISOPROPYL ALCOHOL (UNII: ND2M416302)
  • MALTODEXTRIN (UNII: 7CVR7L4A2D)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE) (UNII: 461P5CJN6T)
  • BUTYL ALCOHOL (UNII: 8PJ61P6TS3)
  • PHOSPHORIC ACID (UNII: E4GA8884NN)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • WATER (UNII: 059QF0KO0R)
  • POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
  • SHELLAC (UNII: 46N107B71O)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • SORBIC ACID (UNII: X045WJ989B)
  • SORBITOL (UNII: 506T60A25R)
  • SOYBEAN OIL (UNII: 241ATL177A)
  • LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
  • SUCROSE (UNII: C151H8M554)
  • TERT-BUTYLHYDROQUINONE (UNII: C12674942B)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

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: 03-01-2018 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 With Gas Relief 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 750 mgSimethicone USP 80 mg

Purpose

AntacidAntigas

Uses

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

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 1-2 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 300 mg •do not store above 25°C (77°F)

Inactive Ingredients

Alcohol, ammonium hydroxide, beeswax, caprylic/capric triglycerides, carnauba wax, citric acid, coconut oil, corn starch, corn syrup, dextrin, ethanol, ethyl acetate, ethyl alcohol, FD&C blue #1 alum lake, FD&C red #40, FD&C red #40 alum lake, FD&C yellow #5 alum lake (tartrazine), FD&C yellow #6 alum lake, flavors, gum arabic, isopropyl alcohol, maltodextrin, methylparaben, modified corn starch, n-butyl alcohol, phosphoric acid, propylene glycol, propylparaben, purified water, PVP, shellac, sodium benzoate, sorbic acid, sorbitol, soy bean oil, soy lecithin, sucrose, TBHQ, titanium dioxide

* Please review the disclaimer below.