SPL v2
SPL
SPL Set ID 2f259f79-d321-5566-e063-6294a90a1522
Route
ORAL
Published
Effective Date 2025-03-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Carbonate Ion (420 mg)
Inactive Ingredients
Magnesium Stearate Aspartame Croscarmellose Sodium Sorbitol Maltodextrin

Identifiers & Packaging

Pill Appearance
Imprint: AZ036 Shape: round Color: white Size: 12 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-02-27

Description

Calcium carbonate 420mg

Purpose

Antacid


Medication Information

Purpose

Antacid

Description

Calcium carbonate 420mg

Uses:

relieves ■ heartburn ■ sour stomach ■ acid indigestion ■ upset stomach due to these symptoms

Section 51945-4

Directions:

■ chew 2 tablets every 2-3 hours or as symptoms occur, repeat hourly if needed

Other Information:

■ Calcium content per tablet: 168mg ■ store at 15°- 30°C (59°-86°F) ■ do not use if imprinted safety seal under cap is broken or missing ■ Phenylketonurics: each tablet contains 1.5mg phenylalanine

Inactive Ingredients:

aspartame, croscarmellose sodium, magnesium stearate, maltodextrin, mint flavor, sorbitol

When Using This Product

do not take more than 19 tablets in a 24 hour period or use the maximum dosage of this product for more than two weeks except under the advice and supervision of a doctor. If symptoms persist for more than two weeks, stop using this product and see a doctor.

Active Ingredient (in Each Tablet)

Calcium carbonate 420mg

Ask A Doctor Or Pharmacist Before Use If You

■ have kidney disease ■ are taking a prescription drug

Antacids may interact with certain prescription drugs


Structured Label Content

Uses:

relieves ■ heartburn ■ sour stomach ■ acid indigestion ■ upset stomach due to these symptoms

Section 51945-4 (51945-4)

Purpose

Antacid

Directions:

■ chew 2 tablets every 2-3 hours or as symptoms occur, repeat hourly if needed

Other Information:

■ Calcium content per tablet: 168mg ■ store at 15°- 30°C (59°-86°F) ■ do not use if imprinted safety seal under cap is broken or missing ■ Phenylketonurics: each tablet contains 1.5mg phenylalanine

Inactive Ingredients: (Inactive ingredients:)

aspartame, croscarmellose sodium, magnesium stearate, maltodextrin, mint flavor, sorbitol

When Using This Product (When using this product)

do not take more than 19 tablets in a 24 hour period or use the maximum dosage of this product for more than two weeks except under the advice and supervision of a doctor. If symptoms persist for more than two weeks, stop using this product and see a doctor.

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

Calcium carbonate 420mg

Ask A Doctor Or Pharmacist Before Use If You (Ask a doctor or pharmacist before use if you)

■ have kidney disease ■ are taking a prescription drug

Antacids may interact with certain prescription drugs


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)