EXTRA STRENGTH- calcium carbonate tablet, chewable
Publix Super Markets Inc

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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Publix Super Markets, Inc. Extra Strength 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 red #40 aluminum lake, flavors, glycerin, magnesium stearate, maltodextrin, mineral oil

Principal Display Panel

extra strength

ANTACID

CALCIUM CARBONATE 750mg

ASSORTED BERRY FLAVORS

Compare to Active Ingredient in Tums® Extra Strength 750 Assorted Berries Flavor

K PAREVE

96 CHEWABLE TABLETS

EXTRA STRENGTH
calcium carbonate tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:56062-489
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	750 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	PINK (dark pink) , PINK (rose) , PURPLE (violet)	Score	no score
Shape	ROUND	Size	17mm
Flavor	BERRY (strawberry, raspberry, berry)	Imprint Code	L489
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:56062-489-80	96 in 1 BOTTLE; Type 0: Not a Combination Product	05/21/2005	07/01/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part331	05/21/2002	07/01/2020

Labeler - Publix Super Markets Inc (006922009)

Revised: 12/2020

Document Id: 839d6203-8149-4020-be4f-4a48361a2f33

Set id: 252400f2-7f0f-4702-b2b6-8edef0c1379b

Version: 4

Effective Time: 20201204

Publix Super Markets Inc