CARE ONE CALCIUM ANTACID- calcium carbonate tablet, chewable
American Sales Company

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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American Sales Company Calcium Antacid Drug Facts

Active ingredient (in each tablet)

Calcium carbonate USP 500mg

Purpose

Antacid

Uses

relieves

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

Warnings

Ask a doctor before use if you have

•: kidney stones
•: a calcium-restricted diet

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 15 tablets in 24 hours
•: if pregnant do not take more than 10 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 tablet contains: calcium 215mg
•: store at 20-25°C (68-77°F)
•: does not meet USP for assay

Inactive ingredients

citric acid, dextrose, FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake, FD&C yellow #5 aluminum lake (tartrazine), FD&C yellow #6 aluminum lake, flavors, glycerin, magnesium stearate, maltodextrin, mineral oil

Questions?

1-800-719-9260

Principal Display Panel

Compare to the active ingredient in Tums® Regular Strength 500 Assorted Fruit

REGULAR STRENGTH

CALCIUM ANTACID

Calcium Carbonate 500mg

Assorted Fruit Flavors

Fast Relief of:

Heartburn and Acid Indigestion

Gluten Free

150 CHEWABLE TABLETS

OUR PHARMACISTS RECOMMEND

CARE ONE CALCIUM ANTACID
calcium carbonate tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:41520-478
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CALCIUM CARBONATE (UNII: H0G9379FGK) (CARBONATE ION - UNII:7UJQ5OPE7D, CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM CARBONATE	500 mg

Ingredient Name	Strength
Inactive Ingredients
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
DEXTROSE (UNII: IY9XDZ35W2)
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)
GLYCERIN (UNII: PDC6A3C0OX)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
MINERAL OIL (UNII: T5L8T28FGP)

Product Characteristics
Color	RED, YELLOW, GREEN, ORANGE	Score	no score
Shape	ROUND	Size	17mm
Flavor	FRUIT (Cherry, lemon, lime, orange)	Imprint Code	L478
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:41520-478-47	150 in 1 BOTTLE; Type 0: Not a Combination Product	03/01/2004	04/01/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part331	03/01/2004	04/01/2020

Labeler - American Sales Company (809183973)

Revised: 12/2018

Document Id: 4ddd16d6-1a3d-4fb9-bfa4-ed59bd7ef8da

Set id: 418fd8ea-fc26-472c-bc27-eec96465d712

Version: 5

Effective Time: 20181214

American Sales Company