Drug Facts

Drug Facts

SPL v2

SPL

SPL Set ID ac839363-94fd-4c60-b5b6-70e4488ce1dd

Route

ORAL

Published

Effective Date 2019-07-10

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Calcium Cation (648 mg)

Inactive Ingredients

Acacia Croscarmellose Sodium Magnesium Stearate Maltodextrin Microcrystalline Cellulose Stearic Acid

Identifiers & Packaging

Pill Appearance

Imprint: PH046 Shape: round Color: white Size: 11 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2019-02-28

Description

Calcium Carbonate 10 gr (648 mg)

Purpose

Antacid

Medication Information

Purpose

Antacid

Description

Calcium Carbonate 10 gr (648 mg)

Uses

relieves

acid indigestion
heartburn
sour stomach
upset stomach associated with these symptoms

Section 42229-5

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL UNDER CAP IS BROKEN OR MISSING

This is a bulk package. Dispense contents with a child-resistant closure in a tight, light-resistant container as defined in the USP.

Warnings

Directions

take one to four tablets daily
do not take more than 4 tablets in 24 hours
do not use the maximum dosage for more than two weeks

Other Information

each tablet contains: calcium 260 mg
store at room temperature

Inactive Ingredients

acacia, croscarmellose sodium, magnesium stearate, maltodextrin, microcrystalline cellulose, stearic acid

Questions Or Comments?

1-800-645-2158

Repackaging Information

Please reference the How Supplied section listed above for a description of individual tablets. This drug product has been received by Aphena Pharma - TN in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below:

Count	648 mg
180	71610-301-80

Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children.

Repackaged by:

Cookeville, TN 38506

20190711JH

Stop Use and Ask A Doctor If

symptoms last more than 2 weeks.

If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of Reach of Children.

Principal Display Panel 648 Mg

NDC 71610-301 - Calcium Carbonate 648 mg Tablets

Active Ingredient (in Each Tablet)

Calcium Carbonate 10 gr (648 mg)

Ask A Doctor Before Use If You Have

kidney stones
a calcium-restricted diet

Ask A Doctor Or Pharmacist Before Use If You Are

taking a prescription drug. Antacids may interact with certain prescription drugs.

Structured Label Content

Uses

relieves

acid indigestion
heartburn
sour stomach
upset stomach associated with these symptoms

Section 42229-5 (42229-5)

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL UNDER CAP IS BROKEN OR MISSING

This is a bulk package. Dispense contents with a child-resistant closure in a tight, light-resistant container as defined in the USP.

Purpose

Antacid

Warnings

Directions

take one to four tablets daily
do not take more than 4 tablets in 24 hours
do not use the maximum dosage for more than two weeks

Other Information (Other information)

each tablet contains: calcium 260 mg
store at room temperature

Inactive Ingredients (Inactive ingredients)

acacia, croscarmellose sodium, magnesium stearate, maltodextrin, microcrystalline cellulose, stearic acid

Questions Or Comments? (Questions or comments?)

1-800-645-2158

Repackaging Information

Count	648 mg
180	71610-301-80

Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children.

Repackaged by:

Cookeville, TN 38506

20190711JH

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

symptoms last more than 2 weeks.

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

Principal Display Panel 648 Mg (PRINCIPAL DISPLAY PANEL - 648 mg)

NDC 71610-301 - Calcium Carbonate 648 mg Tablets

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

Calcium Carbonate 10 gr (648 mg)

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

kidney stones
a calcium-restricted diet

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

taking a prescription drug. Antacids may interact with certain prescription drugs.

Advanced Ingredient Data

[{"name": "ACACIA", "unii": "5C5403N26O", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CROSCARMELLOSE SODIUM", "unii": "M28OL1HH48", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MALTODEXTRIN", "unii": "7CVR7L4A2D", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MICROCRYSTALLINE CELLULOSE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STEARIC ACID", "unii": "4ELV7Z65AP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CALCIUM CATION", "unii": "2M83C4R6ZB", "classCode": "ACTIB", "strengthNumerator": "648", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}]

Raw Label Data

All Sections (JSON)

{"Uses": "relieves acid indigestion heartburn sour stomach upset stomach associated with these symptoms", "42229-5": "TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL UNDER CAP IS BROKEN OR MISSING This is a bulk package. Dispense contents with a child-resistant closure in a tight, light-resistant container as defined in the USP.", "Purpose": "Antacid", "Directions": "take one to four tablets daily do not take more than 4 tablets in 24 hours do not use the maximum dosage for more than two weeks", "Other information": "each tablet contains: calcium 260 mg store at room temperature", "Inactive ingredients": "acacia, croscarmellose sodium, magnesium stearate, maltodextrin, microcrystalline cellulose, stearic acid", "Questions or comments?": "1-800-645-2158", "Repackaging Information": "Please reference the How Supplied section listed above for a description of individual tablets. This drug product has been received by Aphena Pharma - TN in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below: Count 648 mg 180 71610-301-80 Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children. Repackaged by: Cookeville, TN 38506 20190711JH", "Stop use and ask a doctor if": "symptoms last more than 2 weeks.", "If pregnant or breast-feeding,": "ask a health professional before use.", "PRINCIPAL DISPLAY PANEL - 648 mg": "NDC 71610-301 - Calcium Carbonate 648 mg Tablets", "Active ingredient (in each tablet)": "Calcium Carbonate 10 gr (648 mg)", "Ask a doctor before use if you have": "kidney stones a calcium-restricted diet", "Ask a doctor or pharmacist before use if you are": "taking a prescription drug. Antacids may interact with certain prescription drugs."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:18.519036 · Updated: 2026-03-14T23:06:55.199519