SOUND BODY CALCIUM ANTACID- calcium carbonate tablet, chewable
Big Lots Stores, 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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Big Lots, Inc 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

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® Extra Strength 750

EXTRA STRENGTH

750

Calcium Antacid

Calcium Carbonate 750 mg

Assorted Fruit flavored

96 CHEWABLE TABLETS

SOUND BODY CALCIUM ANTACID
calcium carbonate tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50594-004
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
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
MINERAL OIL (UNII: T5L8T28FGP)
MAGNESIUM STEARATE (UNII: 70097M6I30)
GLYCERIN (UNII: PDC6A3C0OX)
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)

Product Characteristics
Color	YELLOW, GREEN, RED, ORANGE	Score	no score
Shape	ROUND	Size	17mm
Flavor	FRUIT (lemon, orange, cherry, lime)	Imprint Code	L179
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:50594-004-80	96 in 1 BOTTLE; Type 0: Not a Combination Product	06/26/2015	07/01/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part331	06/26/2015	07/01/2020

Labeler - Big Lots Stores, Inc. (017885351)

Revised: 11/2021

Document Id: d9bc50f6-68db-4549-b1a7-aa79f08ff310

Set id: fcd76d48-033c-4a70-aa8b-abecd416d1ae

Version: 5

Effective Time: 20211117

Big Lots Stores, Inc.