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 750mg

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 10 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 tablet contains: calcium 320mg
•: store at 20-25°C (68-77°F)
•: does not meet USP for assay

Inactive ingredients

dextrose, FD&C blue #1 aluminum lake, FD&C yellow #5 aluminum lake (tartrazine), flavor, glycerin, magnesium stearate, maltodextrin, mineral oil

Questions?

1-800-719-9260

Package/Label Principal Display Panel

Compare to the active ingredient in Tums® Extra Strength 750 Wintergreen

EXTRA STRENGTH

CALCIUM ANTACID

Calcium Carbonate 750 mg

Wintergreen Flavor

Fast Relief of:

Heartburn and Acid Indigestion

Gluten Free

96 CHEWABLE TABLETS

CARE ONE CALCIUM ANTACID
calcium carbonate tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:41520-528
Route of Administration	ORAL

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

Ingredient Name	Strength
Inactive Ingredients
DEXTROSE (UNII: IY9XDZ35W2)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
MINERAL OIL (UNII: T5L8T28FGP)
GLYCERIN (UNII: PDC6A3C0OX)
MAGNESIUM STEARATE (UNII: 70097M6I30)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Product Characteristics
Color	GREEN (Mottled)	Score	no score
Shape	ROUND	Size	16mm
Flavor	WINTERGREEN	Imprint Code	L528
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:41520-528-80	96 in 1 BOTTLE; Type 0: Not a Combination Product	03/01/2004	01/01/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part331	03/01/2004	01/01/2019

Labeler - American Sales Company (809183973)

Revised: 12/2018

Document Id: e263a23a-bd51-43ca-80e2-1a1582b0504f

Set id: a52f0d20-fe59-48e2-9138-30cbebf322e5

Version: 4

Effective Time: 20181214

American Sales Company