drug facts

drug facts

SPL v3

SPL

SPL Set ID 641ae5b9-3bb6-41a1-ab12-367bf2fbcb0a

Route

oral

Published

Effective Date 2019-07-22

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 2019-07-01

Purpose

Antacid

Description

Calcium Carbonate 10 gr (648 mg)

Medication Information

Active Ingredient

Calcium Carbonate 10 gr (648 mg)

Uses

for the relief of

acid indigestion
heartburn
sour stomach
upset stomach associated with these symptoms

Purpose

Antacid

Directions

adults and children 12 years and over

take 1 to 4 tablets daily or as directed by a doctor

Other Information

each tablet contains: calcium 260 mg
store at 20-25 ^oC (68-77 ^oF)

Inactive Ingredients

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

Description

Calcium Carbonate 10 gr (648 mg)

Section 51945-4

PHARBEST

NDC 73057-377-11

Manufactured in the USA

Calcium

Carbonate

Antacid

10 gr (648 mg)

1000 TABLETS

Do Not Use

more than 4 tablets in 24 hours
the maximum dosage for more than two weeks, unless directed by a doctor

Questions Or Comments?

(866) 562-2756 (Mon- Fri 8 AM to 4 PM EST)

If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of Reach of Children.

Ask A Doctor Before Use If You Have

kidney stones
a calcium-restricted diet

Ask A Doctor Or Pharmacist Before Use If You Are

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

Structured Label Content

Active Ingredient (Active ingredient (in each tablet))

Calcium Carbonate 10 gr (648 mg)

Uses

for the relief of

acid indigestion
heartburn
sour stomach
upset stomach associated with these symptoms

Purpose

Antacid

Directions

adults and children 12 years and over

take 1 to 4 tablets daily or as directed by a doctor

Other Information (Other information)

each tablet contains: calcium 260 mg
store at 20-25 ^oC (68-77 ^oF)

Inactive Ingredients (Inactive ingredients)

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

Section 51945-4 (51945-4)

PHARBEST

NDC 73057-377-11

Manufactured in the USA

Calcium

Carbonate

Antacid

10 gr (648 mg)

1000 TABLETS

Do Not Use (Do not use)

more than 4 tablets in 24 hours
the maximum dosage for more than two weeks, unless directed by a doctor

Questions Or Comments? (Questions or comments?)

(866) 562-2756 (Mon- Fri 8 AM to 4 PM EST)

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.)

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)

presently 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": "for the relief of acid indigestion heartburn sour stomach upset stomach associated with these symptoms", "51945-4": "PHARBEST NDC 73057-377-11 Manufactured in the USA Calcium Carbonate Antacid 10 gr (648 mg) 1000 TABLETS", "Purpose": "Antacid", "Directions": " adults and children 12 years and over take 1 to 4 tablets daily or as directed by a doctor", "Do not use": "more than 4 tablets in 24 hours the maximum dosage for more than two weeks, unless directed by a doctor", "Other information": "each tablet contains: calcium 260 mg store at 20-25 o C (68-77 o F)", "Inactive ingredients": "acacia, croscarmellose sodium, magnesium stearate, maltodextrin, microcrystalline cellulose, stearic acid", "Questions or comments?": "(866) 562-2756 (Mon- Fri 8 AM to 4 PM EST)", "If pregnant or breast-feeding,": "ask a health professional before use.", "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": "presently taking a prescription drug. Antacids may interact with certain prescription drugs."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:23.947838 · Updated: 2026-03-14T23:07:07.673818