Supplement Facts

Drug Labeling and Warnings

Drug Details [pdf]

CALCIUM CARBONATE- calcium carbonate tablet 
West-Ward Pharmaceuticals Corp.

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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Supplement Facts

CALCIUM CARBONATE Tablets (not USP)

Calcium Supplement

Supplement Facts

Serving Size: 1 Tablet

Amount Per Serving

% Daily Value

Calcium 500 mg

50 %

Active Ingredient

Each tablet contains 1250 mg calcium carbonate (equivalent to 500 mg elemental calcium).

Purpose

Antacid

Keep Out of Reach of Children

Keep bottle tightly closed. Store in a cool, dry place, out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.

Uses

For the prevention of calcium deficiency in adults.

Warnings

Do not use more than directed.

As with any supplement, if you are pregnant or nursing a baby, contact your healthcare professional before use.

Do not use if printed foil under cap is broken or missing.

Directions

Take one tablet two to three times daily with meals, or as directed by a physician.

Storage and Handling

Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]

Inactive Ingredients

Magnesium stearate and microcrystalline cellulose.

Questions or Comments

Call 1-800-962-8364. You may also report serious side effects to this phone number.

Distr by: West-Ward

Pharmaceuticals Corp.

Eatontown, NJ 07724

Revised March 2016

Package/Label Principal Display Panel

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Package/Label Principal Display Panel

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CALCIUM CARBONATE 
calcium carbonate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 0054-4120
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CARBONATE1250 mg
Inactive Ingredients
Ingredient NameStrength
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
Product Characteristics
ColorWHITEScore2 pieces
ShapeCAPSULESize19mm
FlavorImprint Code 54;302
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 0054-4120-25100 in 1 BOTTLE; Type 0: Not a Combination Product11/18/200405/24/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33111/18/200405/24/2019
CALCIUM CARBONATE 
calcium carbonate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 0054-8120
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CARBONATE1250 mg
Inactive Ingredients
Ingredient NameStrength
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
Product Characteristics
ColorWHITEScore2 pieces
ShapeCAPSULESize19mm
FlavorImprint Code 54;302
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 0054-8120-2510 in 1 CARTON11/18/200405/24/2019
110 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33111/18/200405/24/2019
Labeler - West-Ward Pharmaceuticals Corp. (080189610)
Establishment
NameAddressID/FEIBusiness Operations
West-Ward Columbus Inc.058839929MANUFACTURE(0054-4120, 0054-8120)

Revised: 5/2019
Document Id: 6911989f-6f31-416b-b534-b783f653608b
Set id: c7165c57-f550-4c9d-9055-1ccf8282c639
Version: 5
Effective Time: 20190524
 
West-Ward Pharmaceuticals Corp.