Your browser does not support JavaScript! CALCIUM ANTACID (CALCIUM CARBONATE) TABLET, CHEWABLE [A&Z PHARMACEUTICAL, INC.]
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CALCIUM ANTACID (calcium carbonate) tablet, chewable
[A&Z Pharmaceutical, Inc.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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.
Drug Label Sections

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 *

W:\Share\Bashir\Labeling\A2Z Artwork & proofs\Antacid Asst 500 mg 50s\antacid asst 500mg 50s front.jpg
CALCIUM ANTACID 
calcium carbonate tablet, chewable
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:62211-219
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALCIUM CARBONATE (CALCIUM CATION) CALCIUM CARBONATE500 mg
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1 
DEXTROSE 
MAGNESIUM STEARATE 
MALTODEXTRIN 
FD&C RED NO. 40 
FD&C YELLOW NO. 6 
D&C YELLOW NO. 10 
Product Characteristics
ColorYELLOW, ORANGE, PINK, GREENScoreno score
ShapeROUNDSize16mm
FlavorLIME, CHERRY, ORANGE, LEMONImprint Code AZ;024
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62211-219-5050 in 1 BOTTLE
2NDC:62211-219-02150 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33112/05/2013
Labeler - A&Z Pharmaceutical, Inc. (926820705)
Registrant - A&Z Pharmaceutical, Inc. (926820705)
Establishment
NameAddressID/FEIBusiness Operations
A&Z Pharmaceutical, Inc.926820705MANUFACTURE(62211-219), LABEL(62211-219), PACK(62211-219)

Revised: 12/2013
 
A&Z Pharmaceutical, Inc.

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