OTC Medication Information: Sound Body Calcium Antacid

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.

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 and magnesium 2mg
store at 20-25° C (68-77° F). Keep the container tightly closed.
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, sucralose

Questions?

1-800-719-9260

Principal Display Panel

Compare to the Active Ingredient in Tums® Smoothies™ Extra Strength 750

EXTRA STRENGTH

750

Calcium

Antacid

Calcium Carbonate 750 mg

Smooth Dissolve

Assorted Fruit Flavored

60 CHEWABLE TABLETS

calcium-antacid-image
(click image for full-size original)
SOUND BODY CALCIUM ANTACID
calcium carbonate tablet, chewable
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:50594-028
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CALCIUM CARBONATE (CALCIUM CATION and CARBONATE ION) CALCIUM CARBONATE 750 mg
Inactive Ingredients
Ingredient Name Strength
CITRIC ACID MONOHYDRATE
DEXTROSE
FD&C BLUE NO. 1
FD&C RED NO. 40
FD&C YELLOW NO. 5
FD&C YELLOW NO. 6
GLYCERIN
MAGNESIUM STEARATE
MALTODEXTRIN
MINERAL OIL
SUCRALOSE
Product Characteristics
Color PINK (cherry, strawberry) , ORANGE (orange) , YELLOW (lemon) Score no score
Shape ROUND Size 19mm
Flavor FRUIT Imprint Code L9Y7
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50594-028-72 60 TABLET, CHEWABLE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part331 06/15/2018
Labeler — Big Lots Stores, Inc. (017885351)

Revised: 06/2018 Big Lots Stores, Inc.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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