ANTACID- calcium carbonate tablet 
Safetec of America, 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 (per tablet)

Calcium Carbonate USP 750 mg

Purpose

Antacid

Uses relieves

Warnings

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 10 tablets in 24 hours
  • if pregnant do not take more than 6 tablets in 24 hours
  • do not use the maximum dosage for more than 2 weeks except under the advice and supervision of a doctor

Directions

Keep out of reach of children.

  • 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

Inactive ingredients

dextrose, flavor (peppermint), magnesium stearate, maltodextrin

Questions or comments?

Call toll free: 1-800-456-7077

Principal Display Panel - 750 mg Pouch Label

Safetec
of America, Inc.

DO NOT USE IF POUCH IS TORN OR DAMAGED

Manufactured for Safetec of America, Inc.
Buffalo NY 14215

EXTRA STRENGTH

Antacid

Calcium Carbonate 750 mg

2 Chewable Tablets

Principal Display Panel - 750 mg Pouch Label

Principal Display Panel – 50 Count Carton

Safetec®
of America, Inc.

*Compare to the active
ingredient in TUMS® EX

NDC 61010-4408-1

Antacid

Calcium Carbonate 750 mg – Extra Strength

TAMPER EVIDENT UNIT DOSE POUCHES

DO NOT USE IF POUCH IS TORN OR DAMAGED

50 Pouches 2 Tablets per pouch

Principal Display Panel – 50 Count Carton

Principal Display Panel – 100 Count Carton

Safetec®
of America, Inc.

*Compare to the active
ingredient in TUMS® EX

NDC 61010-4408-2

Antacid

Calcium Carbonate 750 mg – Extra Strength

PUSH TO OPEN

Dispense
through opening

TAMPER EVIDENT UNIT DOSE POUCHES

DO NOT USE IF POUCH IS TORN OR DAMAGED

100 Pouches 2 Tablets per pouch

Principal Display Panel – 100 Count Carton
ANTACID 
calcium carbonate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61010-4408
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)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
PEPPERMINT (UNII: V95R5KMY2B)  
Product Characteristics
Colorwhite (WHITE) Scoreno score
ShapeROUND (ROUND) Size16mm
FlavorImprint Code AP;052
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61010-4408-02 in 1 POUCH; Type 0: Not a Combination Product12/30/2019
2NDC:61010-4408-150 in 1 BOX12/30/2019
2NDC:61010-4408-02 in 1 POUCH; Type 0: Not a Combination Product
3NDC:61010-4408-2100 in 1 BOX12/30/2019
3NDC:61010-4408-02 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33112/30/2019
Labeler - Safetec of America, Inc. (874965262)

Revised: 12/2019
Document Id: 6b955c6f-61cd-47d1-b103-e76d21a7af52
Set id: fdc3a8b9-3edf-4339-9656-623973b32ea5
Version: 2
Effective Time: 20191230
 
Safetec of America, Inc.