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 Navajo Manufacturing Company 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. Crush or chew tablets completely before swallowing.
• 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)
• contains FD&C Yellow No. 5 (tartrazine) as a color additive

Inactive ingredients

acacia, beeswax, carmine, carnauba wax, citric acid, coconut oil, corn starch, corn syrup, dextrin, FD&C blue no. 2 aluminum lake, FD&C red no. 40, FD&C red no. 40 aluminum lake, FD&C yellow no. 5 aluminum lake (tartrazine), maltodextrin, medium chain triglycerides, methylparaben, natural and artificial flavors, pharmaceutical ink, phosphoric acid, povidone, propylene glycol, propylparaben, purified water, shellac, sodium benzoate, sorbic acid, sorbitol, soy lecithin, sucrose, titanium dioxide, triacetin, vegetable oil

Questions or comments?

1-800-897-7535

Principal Display Panel

INGREDIENTS AND APPEARANCE

TUMS CHEWY BITES 
calcium carbonate tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67751-235(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)
STARCH, WHEAT (UNII: 79QS2MG2LP)
ETHYL ACETATE (UNII: 76845O8NMZ)
FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)
FD&C BLUE NO. 2 ALUMINUM LAKE (UNII: 4AQJ3LG584)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C RED NO. 40 ALUMINUM LAKE (UNII: 6T47AS764T)
FD&C YELLOW NO. 5 ALUMINUM LAKE (UNII: JQ6BLH9FR7)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
FD&C YELLOW NO. 6 ALUMINUM LAKE (UNII: GYP6Z2JR6Q)
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)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
SHELLAC (UNII: 46N107B71O)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SORBIC ACID (UNII: X045WJ989B)
SORBITOL (UNII: 506T60A25R)
SOYBEAN (UNII: L7HT8F1ZOD)
SOYBEAN LECITHIN (UNII: 1DI56QDM62)
SUCROSE (UNII: C151H8M554)
TERT-BUTYLHYDROQUINONE (UNII: C12674942B)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIACETIN (UNII: XHX3C3X673)
CORN OIL (UNII: 8470G57WFM)

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: 67751-235-01	1 in 1 CARTON	12/02/2024
1		2 in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M001	12/02/2024

Labeler - Navajo Manufacturing Company Inc. (091917799)

Registrant - Navajo Manufacturing Company Inc. (136941411)

Establishment
Name	Address	ID/FEI	Business Operations
Navajo Manufacturing Company Inc.		136941411	repack(67751-235)