CALCIUM ANTACID- calcium carbonate tablet, chewable
A&Z Pharmaceutical, 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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Drug Facts

Active ingredient

Calcium Carbonate 500 mg

Purpose

Acid Indigestion, Heartburn, Sour & Upset Stomach

Uses

relieves

•: heartburn
•: acid
•: indigestion
•: sour stomach
•: upset stomach due to these symptoms

Warnings

Ask a doctor or pharmacist before use if you are

When Using

do not take more than 15 tablets in a 24 hour period or use the maximum dosage of this product for more than two weeks.

Keep Out of Reach of Children

Directions

•: chew 2-4 tablets as symptoms occur, repeat hourly if needed

Other Information

•: store at 59°-86°F
•: do not use if imprinted safety seal under cap is broken or missing
•: Calcium content per tablet: 200mg

Supplement Facts

•: Serving size 2 tablets
•: Servings per Container: 25
•: Amount Per Serving
Calories: 5
Calcium: 400mg(40%DV)

Inactive Ingredients

Blue #1, dextrose, flavors, magnesium stearate, maltodextrin, red #40, yellow #6, yellow #10

Manufactured by:

A&Z Pharmaceutical, Inc.
Happauge, NY 11788

Package/Label Principal Display Panel

Sodium Free

CALCIUM ANTACID

Regular Strength

500 mg

Calcium Supplement

Fast Relief of Acid Indigestion, Heartburn, Sour & Upset Stomach

50 Tablets

Assorted Fruit Chewable Tablets

Compare to Tums ® Active Ingredient *

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CALCIUM ANTACID
calcium carbonate tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:62211-219
Route of Administration	ORAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM CARBONATE	500 mg

Ingredient Name	Strength
Inactive Ingredients
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
DEXTROSE (UNII: IY9XDZ35W2)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)

Product Characteristics
Color	YELLOW, ORANGE, PINK, GREEN	Score	no score
Shape	ROUND	Size	16mm
Flavor	LIME, CHERRY, ORANGE, LEMON	Imprint Code	AZ;024
Contains

#	Item Code	Package Description
Packaging
1	NDC:62211-219-50	50 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC:62211-219-02	150 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part331	12/05/2013	04/16/2015

Labeler - A&Z Pharmaceutical, Inc. (926820705)

Registrant - A&Z Pharmaceutical, Inc. (926820705)

Name	Address	ID/FEI	Business Operations
Establishment
A&Z Pharmaceutical, Inc.		926820705	MANUFACTURE(62211-219) , LABEL(62211-219) , PACK(62211-219)

Revised: 4/2015

Document Id: 61bac10c-afa8-44e6-8831-12960c487e91

Set id: 33376895-edf5-4dde-8614-b9798e97b9ed

Version: 3

Effective Time: 20150416

A&Z Pharmaceutical, Inc.