Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID 636a00a9-9df5-40cb-940a-61cc52016a1b
Route
ORAL
Published
Effective Date 2013-12-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Calcium Cation (500 mg)
Inactive Ingredients
Fd&c Blue No. 1 Dextrose Magnesium Stearate Maltodextrin Fd&c Red No. 40 Fd&c Yellow No. 6 D&c Yellow No. 10

Identifiers & Packaging

Pill Appearance
Imprint: AZ;024 Shape: round Color: yellow Color: orange Color: pink Color: green Size: 16 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2014-08-25

Description

Calcium Carbonate 500 mg

Purpose

Acid Indigestion, Heartburn, Sour & Upset Stomach


Medication Information

Purpose

Acid Indigestion, Heartburn, Sour & Upset Stomach

Description

Calcium Carbonate 500 mg

Uses

relieves

  • heartburn
  • acid indigestion
  • sour stomach
  • upset stomach associated with these symptoms
Directions
  • chew 2-4 tablets as symptoms occur, repeat hourly if needed
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.

Supplement Facts
  • Serving size 2 tablets
  • Servings per Container: 50
  • Amount Per Serving

    Calories: 5

    Calcium: 400mg(40%DV)
Active Ingredient

Calcium Carbonate 500 mg

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
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


Structured Label Content

Uses

relieves

  • heartburn
  • acid indigestion
  • sour stomach
  • upset stomach associated with these symptoms
Purpose

Acid Indigestion, Heartburn, Sour & Upset Stomach

Directions
  • chew 2-4 tablets as symptoms occur, repeat hourly if needed
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.

Supplement Facts
  • Serving size 2 tablets
  • Servings per Container: 50
  • Amount Per Serving

    Calories: 5

    Calcium: 400mg(40%DV)
Active Ingredient (Active ingredient)

Calcium Carbonate 500 mg

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
Inactive Ingredients

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

Packaged and Distributed By: (Packaged and Distributed by:)

Safecor Health, LLC

317 New Boston Street, Suite 100

Woburn, MA 01801

Package/label Principal Display Panel (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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)