TOPCARE ANTACID CALCIUM REGULAR STRENGTH- calcium carbonate tablet, chewable
Topco Associates LLC

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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Topco Associates LLC. Antacid Calcium 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

dextrose, flavor, glycerin, magnesium stearate, maltodextrin, mineral oil

Questions?

1-888-423-0139

Principal Display Panel

DO NOT USE IF PRINTED SEAL UNDER CAP IS BROKEN OR MISSING

REGULAR STRENGTH

Antacid Calcium

CALCIUM CARBONATE

500 mg

Starts working in seconds

Peppermint Flavor

COMPARE TO TUMS® REGULAR STRENGTH 500 active ingredient

150 CHEWABLE TABLETS

K PAREVE

TOPCARE ANTACID CALCIUM REGULAR STRENGTH
calcium carbonate tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:36800-485
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
DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
MINERAL OIL (UNII: T5L8T28FGP)
GLYCERIN (UNII: PDC6A3C0OX)
MAGNESIUM STEARATE (UNII: 70097M6I30)

Product Characteristics
Color	WHITE	Score	no score
Shape	ROUND	Size	17mm
Flavor	PEPPERMINT	Imprint Code	L485
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:36800-485-47	150 in 1 BOTTLE; Type 0: Not a Combination Product	09/10/1991	10/01/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part331	09/10/1991	10/01/2020

Labeler - Topco Associates LLC (006935977)

Revised: 12/2020

Document Id: 46cce304-cb70-4c21-8fef-17b7b138ec75

Set id: f8eee642-74e2-46c9-b42a-c621743c9663

Version: 5

Effective Time: 20201210

Topco Associates LLC