ANTACID- calcium carbonate tablet, chewable
HyVee 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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Hy-Vee, Inc. Antacid Tablets Drug Facts

Active ingredient (in each tablet)

Calcium carbonate USP 500mg

Purpose

Antacid

Uses

relieves

•: heartburn
•: sour stomach
•: acid indigestion
•: 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

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 of Tums® Regular Strength 500

Antacid Tablets

Calcium Carbonate 500 mg

Regular Strength

Assorted Fruit Flavors

150 CHEWABLE TABLETS

ANTACID
calcium carbonate tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:42507-478
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CALCIUM CARBONATE (UNII: H0G9379FGK) (CARBONATE ION - UNII:7UJQ5OPE7D)	CALCIUM CARBONATE	500 mg

Ingredient Name	Strength
Inactive Ingredients
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
DEXTROSE (UNII: IY9XDZ35W2)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
MINERAL OIL (UNII: T5L8T28FGP)
GLYCERIN (UNII: PDC6A3C0OX)
MAGNESIUM STEARATE (UNII: 70097M6I30)

Product Characteristics
Color	RED, YELLOW, GREEN, ORANGE	Score	no score
Shape	ROUND	Size	17mm
Flavor	FRUIT (Cherry, lemon, lime, orange)	Imprint Code	L478
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:42507-478-47	150 in 1 BOTTLE; Type 0: Not a Combination Product	08/28/1992	04/01/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part331	08/28/1992	04/01/2019

Labeler - HyVee Inc (006925671)

Revised: 12/2018

Document Id: 19e59de7-083a-4840-a545-2a3ee1d9418b

Set id: 2a2d65d1-0e81-455c-beb1-3887b9fd2720

Version: 3

Effective Time: 20181210

HyVee Inc