Calcium Carbonate 1000 Mg

SPL v1

SPL

SPL Set ID 4a6451d7-b39f-37ac-e054-00144ff8d46c

Route

ORAL

Published

Effective Date 2017-01-31

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Calcium Cation (1000 mg)

Inactive Ingredients

Water

Identifiers & Packaging

Pill Appearance

Imprint: FC Shape: round Color: green Size: 14 mm Score: 1

Marketing Status

OTC MONOGRAPH FINAL Active Since 2017-01-31

Description

Active ingredient (in each chew) Calcium Carbonate 1000 mg

Medication Information

Warnings and Precautions

Warnings

Do not use if you have ever had an allergic reaction to this product or any of its ingredients.

Indications and Usage

Uses: Relieves

Heartburn

Sour stomach

Acid indigestion

Upset stomach due to these symptoms

Dosage and Administration

Directions

Adults and children 12 years and older chew and swallow 1 to 2 chews as symptoms occur. Do not exceed 7 chews in 24 hours.

Children under 12 years consult a doctor.

Description

Active ingredient (in each chew) Calcium Carbonate 1000 mg

Section 50565-1

Keep out of reach of children.

Section 50567-7

When using this product do not take more than 7 chews in a 24-hour period, or use the maximum dosage for more than 2 weeks, except under the advice and supervision of a physician.

When using this product constipation may occur.

Section 50568-5

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

Section 51727-6

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

Section 51945-4

Section 53413-1

Questions? Call 1-800-245-2898 Monday through Friday, 9AM - 4PM EST

Section 55105-1

Purpose

Antacid

Section 55106-9

Active ingredient (in each chew)

Calcium Carbonate 1000 mg

Section 60561-8

Each chew contains: calcium 400mg, magnesium 1mg, sodium 1mg

Contains soy

Contains FD&C yellow No. 5 (tartrazine) as a color additive

Structured Label Content

Indications and Usage (34067-9)

Uses: Relieves

Heartburn

Sour stomach

Acid indigestion

Upset stomach due to these symptoms

Dosage and Administration (34068-7)

Directions

Adults and children 12 years and older chew and swallow 1 to 2 chews as symptoms occur. Do not exceed 7 chews in 24 hours.

Children under 12 years consult a doctor.

Warnings and Precautions (34071-1)

Warnings

Do not use if you have ever had an allergic reaction to this product or any of its ingredients.

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50567-7 (50567-7)

When using this product do not take more than 7 chews in a 24-hour period, or use the maximum dosage for more than 2 weeks, except under the advice and supervision of a physician.

When using this product constipation may occur.

Section 50568-5 (50568-5)

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

Section 51727-6 (51727-6)

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

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions? Call 1-800-245-2898 Monday through Friday, 9AM - 4PM EST

Section 55105-1 (55105-1)

Purpose

Antacid

Section 55106-9 (55106-9)

Active ingredient (in each chew)

Calcium Carbonate 1000 mg

Section 60561-8 (60561-8)

Each chew contains: calcium 400mg, magnesium 1mg, sodium 1mg

Contains soy

Contains FD&C yellow No. 5 (tartrazine) as a color additive

Advanced Ingredient Data

[{"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CALCIUM CATION", "unii": "2M83C4R6ZB", "classCode": "ACTIB", "strengthNumerator": "1000", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Uses: Relieves Heartburn Sour stomach Acid indigestion Upset stomach due to these symptoms", "34068-7": "Directions Adults and children 12 years and older chew and swallow 1 to 2 chews as symptoms occur. Do not exceed 7 chews in 24 hours. Children under 12 years consult a doctor.", "34071-1": "Warnings Do not use if you have ever had an allergic reaction to this product or any of its ingredients.", "50565-1": "Keep out of reach of children.", "50567-7": "When using this product do not take more than 7 chews in a 24-hour period, or use the maximum dosage for more than 2 weeks, except under the advice and supervision of a physician. When using this product constipation may occur.", "50568-5": "Ask a doctor or pharmacist before use if you are now taking a prescription drug. Antacids may interact with certain prescription drugs.", "51727-6": "If pregnant of breast-feeding, ask a health professional before use.", "53413-1": "Questions? Call 1-800-245-2898 Monday through Friday, 9AM - 4PM EST", "55105-1": "Purpose Antacid", "55106-9": "Active ingredient (in each chew) Calcium Carbonate 1000 mg", "60561-8": "Each chew contains: calcium 400mg, magnesium 1mg, sodium 1mg Contains soy Contains FD&C yellow No. 5 (tartrazine) as a color additive"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:17.289333 · Updated: 2026-03-14T22:54:39.402137