TUMS CHEWY BITES WITH GAS RELIEF- calcium carbonate and simethicone tablet, chewable

Tums Chewy Bites with Gas Relief by

Drug Labeling and Warnings

Tums Chewy Bites with Gas Relief by is a Otc medication manufactured, distributed, or labeled by GlaxoSmithKline Consumer Healthcare Holdings (US) LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (per tablet)

Calcium Carbonate USP 750 mg

Simethicone USP 80 mg

Purpose

Antacid

Antigas

Uses

relieves

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

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 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

Keep out of reach of children.

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

Questions or comments?

Call toll-free 1-800-897-7535

Principal Display Panel

NEW

NDC: 0135-0624-01

TUMS® with Gas Relief

CALCIUM CARBONATE / SIMETHICONE

ANTACID/ANTIGAS

Chewy Bites

Lemon & Strawberry

FAST RELIEF OF HEARTBURN & GAS

28 CHEWABLE TABLETS

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

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

Distributed by:

GSK Consumer Healthcare

Warren, NJ 07059

©2016 GSK or its licensor

106111XA

INGREDIENTS AND APPEARANCE

TUMS CHEWY BITES WITH GAS RELIEF 
calcium carbonate and simethicone tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0135-0624
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB, CARBONATE ION - UNII:7UJQ5OPE7D)	CALCIUM CARBONATE	750 mg
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	80 mg

Inactive Ingredients
Ingredient Name	Strength
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)

Product Characteristics
Color	RED (red, yellow)	Score	no score
Shape	ROUND	Size	19mm
Flavor	STRAWBERRY (Strawberry, Lemon)	Imprint Code	T
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0135-0624-01	28 in 1 BOTTLE; Type 0: Not a Combination Product	03/01/2018
2	NDC: 0135-0624-02	54 in 1 BOTTLE; Type 0: Not a Combination Product	03/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part331	03/01/2018

Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)