763-ble

763-ble
SPL v3
SPL
SPL Set ID 99d7e467-a3db-b4f0-e053-2a95a90a900f
Route
ORAL
Published
Effective Date 2013-01-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Imprint: AZ;024 Shape: round Color: red Color: green Color: orange Color: yellow Size: 14 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2015-04-01

Description

Calcium Carbonate 500 mg

Purpose

Antacid


Medication Information

Purpose

Antacid

Description

Calcium Carbonate 500 mg

Uses

temporarily relieves:

  • acid indigestion
  • heartburn
  • sour stomach
Section 50565-1

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Warnings

Ask a doctor before use if you have kidney stones.

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

Stop use and ask a doctor if symptoms last more than 2 weeks.

When using this product do not use the maximum dosage for more than 2 weeks

If pregnant or breast feeding, ask a health professional before use.

Directions

• do not exceed recommended dose

• adults and children 12 years of age and older:

• chew 2 to 4 tablets as symptoms occur, or as directed by a doctor

• do not take more than 15 tablets in 24 hours

• if pregnant, do not take more than 10 tablets in 24 hours

• children under 12 years: ask a doctor

Package Label

Other Information
  • each tablet contains: calcium 200 mg
  • Store below 30°C (86°F). Keep the container tightly closed.
  • Tamper Evident: Do not use if imprinted seal under cap is

    missing or broken.
Inactive Ingredients

assorted flavors, D&C Yellow #10 lake, dextrose, FD&C Blue #1 lake, FD&C Red #40 lake, FD&C Yellow #6 lake, magnesium stearate, maltodextrin

Active Ingredient (in Each Tablet)

Calcium Carbonate 500 mg


Structured Label Content

Uses

temporarily relieves:

  • acid indigestion
  • heartburn
  • sour stomach
Section 50565-1 (50565-1)

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Purpose

Antacid

Warnings

Ask a doctor before use if you have kidney stones.

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

Stop use and ask a doctor if symptoms last more than 2 weeks.

When using this product do not use the maximum dosage for more than 2 weeks

If pregnant or breast feeding, ask a health professional before use.

Directions

• do not exceed recommended dose

• adults and children 12 years of age and older:

• chew 2 to 4 tablets as symptoms occur, or as directed by a doctor

• do not take more than 15 tablets in 24 hours

• if pregnant, do not take more than 10 tablets in 24 hours

• children under 12 years: ask a doctor

Package Label (Package label)

Other Information (Other information)
  • each tablet contains: calcium 200 mg
  • Store below 30°C (86°F). Keep the container tightly closed.
  • Tamper Evident: Do not use if imprinted seal under cap is

    missing or broken.
Inactive Ingredients (Inactive ingredients)

assorted flavors, D&C Yellow #10 lake, dextrose, FD&C Blue #1 lake, FD&C Red #40 lake, FD&C Yellow #6 lake, magnesium stearate, maltodextrin

Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Calcium Carbonate 500 mg


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)