TUMS CHEWY BITES- calcium carbonate tablet, chewable

Tums Chewy Bites by

Drug Labeling and Warnings

Tums Chewy Bites by is a Otc medication manufactured, distributed, or labeled by GlaxoSmithKline Consumer Healthcare Holdings (US) LLC, Specialty Minerals Incorporated, Omya Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (per tablet)

Calcium Carbonate USP 750mg

Purpose

Antacid

Uses

relieves

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

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 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, caprylic/capric triglycerides, 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, FD&C red #40 alum lake, FD&C yellow #5 alum lake (tartrazine), FD&C yellow #6, FD&C yellow #6 alum lake, flavors, gum arabic, isopropyl alcohol, maltodextrin, methyl paraben, modified corn starch, n-butyl alcohol, phosphoric acid, PVP, propyl paraben, propylene glycol, purified water, shellac, sodium benzoate, sorbic acid, sorbitol, soy bean oil, soy lecithin, sucrose, TBHQ, titanium dioxide, triacetin, vegetable oil

Questions?

Call 1-800-897-7535

Principal Display Panel

NDC: 0135-0606-02

TUMS®

CALCIUM CARBONATE

ANTACID

Chewy Bites

Assorted Berries

NEW

GOES TO WORK IN SECONDS!

EXTRA STRENGTH 750

60 CHEWABLE TABLETS

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

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

Front Label: 105592XA

Back Label: 105591XA

Principal Display Panel

NDC: 0135-0606-04

TUMS®

CALCIUM CARBONATE

ANTACID

Chewy Bites

Assorted Berries

GOES TO WORK IN SECONDS!

EXTRA STRENGTH 750

8 CHEWABLE TABLETS

Do not use if printed inner safety seal under cap is broken or missing.

Distributed by:

GSKConsumer Healthcare

Warren, NJ 07059

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

©2019 GSK group of companies or its licensor

Front Label: 1000369

Back Label: 1000233

INGREDIENTS AND APPEARANCE

TUMS CHEWY BITES 
calcium carbonate tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0135-0606
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

Inactive Ingredients
Ingredient Name	Strength
ACACIA (UNII: 5C5403N26O)
ALCOHOL (UNII: 3K9958V90M)
AMMONIA (UNII: 5138Q19F1X)
YELLOW WAX (UNII: 2ZA36H0S2V)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CARMINIC ACID (UNII: CID8Z8N95N)
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)
ALUMINUM OXIDE (UNII: LMI26O6933)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
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)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
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)
TRIACETIN (UNII: XHX3C3X673)

Product Characteristics
Color	RED (red, pink, purple)	Score	no score
Shape	ROUND	Size	19mm
Flavor	STRAWBERRY (Assorted Berry: Strawberry, Raspberry, Mixed Berry)	Imprint Code	T
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0135-0606-01	32 in 1 BOTTLE; Type 0: Not a Combination Product	03/01/2017
2	NDC: 0135-0606-02	60 in 1 BOTTLE; Type 0: Not a Combination Product	03/01/2017
3	NDC: 0135-0606-04	8 in 1 BOTTLE; Type 0: Not a Combination Product	01/02/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part331	03/01/2017

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

Establishment
Name	Address	ID/FEI	Business Operations
Specialty Minerals Incorporated		796649390	API MANUFACTURE(0135-0606)

Establishment
Name	Address	ID/FEI	Business Operations
Omya Inc.		117198571	API MANUFACTURE(0135-0606)

Establishment
Name	Address	ID/FEI	Business Operations
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC		046877908	LABEL(0135-0606) , PACK(0135-0606)