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 750 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 10 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: 300 mg

Supplement Facts

•
Serving size 2 tablets
•
Servings per Container: 50
•
Amount Per Serving
Calories: 10
Calcium: 600 mg(60%DV)

Inactive Ingredients

dextrose, FD&CBlue #1, FD&C Red #40, flavors, magnesium stearate, maltodextrin

Packaged and Distributed by:

Safecor Health, LLC
Woburn, MA 01801

Package/Label Principal Display Panel

Sodium Free

CALCIUM ANTACID

Extra Strength

750 mg

Assorted Berry flavor Chewable Tablets

Calcium Antacid 750 mg UD box label
CALCIUM ANTACID 
calcium carbonate tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:48433-107(NDC:69168-229)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CARBONATE750 mg
Inactive Ingredients
Ingredient NameStrength
DEXTROSE (UNII: IY9XDZ35W2)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
Product Characteristics
ColorGRAY, RED, PURPLE, orangeScoreno score
ShapeROUNDSize16mm
FlavorLIME, CHERRY, ORANGE, LEMONImprint Code RH031
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:48433-107-10100 in 1 BOX, UNIT-DOSE10/01/2014
1NDC:48433-107-011 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33110/01/201408/01/2023
Labeler - Safecor Health, LLC (828269675)
Establishment
NameAddressID/FEIBusiness Operations
Safecor Health, LLC828269675REPACK(48433-107)
Establishment
NameAddressID/FEIBusiness Operations
Safecor Health, LLC078805287REPACK(48433-107)

Revised: 2/2023
Document Id: 2f4aaaac-51e6-4300-a156-407bc8641bcc
Set id: 3c2efeee-7e66-4b2b-8fc9-5e68f6076b0b
Version: 2
Effective Time: 20230207
 
Safecor Health, LLC