Calcium Carbonate 500 Mg

SPL v7

SPL

SPL Set ID 322f1b54-abe9-11a7-e054-00144ff8d46c

Route

ORAL

Published

Effective Date 2015-11-01

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Calcium Cation (500 mg)

Inactive Ingredients

Fd&c Yellow No. 6 Magnesium Stearate D&c Yellow No. 10 Fd&c Blue No. 1 D&c Red No. 27 Dextrose

Identifiers & Packaging

Pill Appearance

Imprint: AP;043 Shape: round Color: blue Color: orange Color: yellow Color: purple Size: 16 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2015-11-01

Description

Drug Facts

Purpose

Antacid

Medication Information

Indications and Usage

Uses relieves

acid indigestion
heartburn
sour stomach

Purpose

Antacid

Description

Drug Facts

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

Section 50566-9

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

Section 50568-5

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

Section 51945-4

NDC 69618-020-15 *Compare to Active Ingredient of Tums® Regular Strength

ASSORTED FLAVORS

Calcium Carbonate

500 mg

ANTACID

150 CHEWABLE TABLETS

*Reliable-1 Laboratories LLC is not affiliated with the owner of the trademark Tums®

Warnings

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

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

Keep out of reach of children.

Directions

Adults and children 12 years and over:

chew 2-4 tablets as symptoms occur
do not take more than 8 tablets in 24 hours
do not use the maximum dosage for more than 2 weeks

children under 12 years:

ask a doctor

Other Information

each tablet contains: calcium 200 mg
store at room temperature

Inactive Ingredients

Al-lakes (D&C red #27, D&C yellow #10, FD&C blue #1, FD&C yellow #6), dextrose, flavors, magnesium stearate, maltodextrin

Questions Or Comments?

call 516-341-0666, 8:30 am - 4:30 pm ET, Monday-Friday

Active Ingredient (in Each Chewable Tablet)

Calcium carbonate 500 mg

Structured Label Content

Indications and Usage (34067-9)

Uses relieves

acid indigestion
heartburn
sour stomach

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50566-9 (50566-9)

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

Section 50568-5 (50568-5)

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

Section 51945-4 (51945-4)

NDC 69618-020-15 *Compare to Active Ingredient of Tums® Regular Strength

ASSORTED FLAVORS

Calcium Carbonate

500 mg

ANTACID

150 CHEWABLE TABLETS

*Reliable-1 Laboratories LLC is not affiliated with the owner of the trademark Tums®

Purpose

Antacid

Warnings

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

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

Keep out of reach of children.

Directions

Adults and children 12 years and over:

chew 2-4 tablets as symptoms occur
do not take more than 8 tablets in 24 hours
do not use the maximum dosage for more than 2 weeks

children under 12 years:

ask a doctor

Other Information (Other information)

each tablet contains: calcium 200 mg
store at room temperature

Inactive Ingredients (Inactive ingredients)

Al-lakes (D&C red #27, D&C yellow #10, FD&C blue #1, FD&C yellow #6), dextrose, flavors, magnesium stearate, maltodextrin

Questions Or Comments? (Questions or comments?)

call 516-341-0666, 8:30 am - 4:30 pm ET, Monday-Friday

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

Calcium carbonate 500 mg

Advanced Ingredient Data

[{"name": "FD&C YELLOW NO. 6", "unii": "H77VEI93A8", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "D&C YELLOW NO. 10", "unii": "35SW5USQ3G", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C BLUE NO. 1", "unii": "H3R47K3TBD", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "D&C RED NO. 27", "unii": "2LRS185U6K", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DEXTROSE", "unii": "IY9XDZ35W2", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CALCIUM CATION", "unii": "2M83C4R6ZB", "classCode": "ACTIB", "strengthNumerator": "500", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Uses relieves acid indigestion heartburn sour stomach", "42229-5": "Drug Facts", "50565-1": "Keep out of reach of children.", "50566-9": "Stop use and ask doctor if symptoms last more than 2 weeks", "50568-5": "Ask a doctor or pharmacist before use if you are taking a prescription drug. Antacids may interact with certain prescription drugs.", "51945-4": "NDC 69618-020-15 *Compare to Active Ingredient of Tums® Regular Strength ASSORTED FLAVORS Calcium Carbonate 500 mg ANTACID 150 CHEWABLE TABLETS *Reliable-1 Laboratories LLC is not affiliated with the owner of the trademark Tums®", "Purpose": "Antacid", "Warnings": "Ask a doctor or pharmacist before use if you are taking a prescription drug. Antacids may interact with certain prescription drugs. Stop use and ask a doctor if symptoms last more than 2 weeks Keep out of reach of children.", "Directions": "Adults and children 12 years and over: chew 2-4 tablets as symptoms occur do not take more than 8 tablets in 24 hours do not use the maximum dosage for more than 2 weeks children under 12 years: ask a doctor", "Other information": "each tablet contains: calcium 200 mg store at room temperature", "Inactive ingredients": "Al-lakes (D&C red #27, D&C yellow #10, FD&C blue #1, FD&C yellow #6), dextrose, flavors, magnesium stearate, maltodextrin", "Questions or comments?": "call 516-341-0666, 8:30 am - 4:30 pm ET, Monday-Friday", "Active ingredient (in each chewable tablet)": "Calcium carbonate 500 mg"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:22.055848 · Updated: 2026-03-14T23:07:03.829205