CALCIUM ANTACID- calcium carbonate tablet, chewable 
Safecor Health, LLC

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 associated with these symptoms

Warnings

Ask a doctor or pharmacist before use if you are taking a prescription drug. Antacids may interact with certain prescription drugs.

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: 50
Amount Per Serving
Calories: 5
Calcium: 400mg(40%DV)

Inactive Ingredients

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

Packaged and Distributed by:

Safecor Health, LLC
317 New Boston Street, Suite 100

Woburn, MA 01801

Package/Label Principal Display Panel

SAFECOR HEALTH

CALCIUM ANTACID

Regular Strength

500 mg

NDC 48433-106-01

Fruit Flavored Chewable Tablets

Compare to Tums ® Active Ingredient *

This package is not child resistant. For institutional use only.

This product is not manufactured or distributed by GlaxoSmithKline, distributor of Tums®

Questions or comments? Call 1-800-447-1006

100 Unit Dose Chewable Tablets

Calcium Antacid 500 mg Unit Dose Box Label
CALCIUM ANTACID 
calcium carbonate tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:48433-106(NDC:69168-219)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CARBONATE500 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorYELLOW, ORANGE, PINK, GREENScoreno score
ShapeROUNDSize16mm
FlavorLIME, CHERRY, ORANGE, LEMONImprint Code AZ;024
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:48433-106-01100 in 1 BOX, UNIT-DOSE; Type 0: Not a Combination Product08/25/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33108/25/2014
Labeler - Safecor Health, LLC (828269675)
Establishment
NameAddressID/FEIBusiness Operations
Safecor Health, LLC078805287REPACK(48433-106)

Revised: 1/2022
Document Id: 2a94a14b-9339-4f5b-8428-d4e24c0aac35
Set id: 636a00a9-9df5-40cb-940a-61cc52016a1b
Version: 2
Effective Time: 20220126
 
Safecor Health, LLC