Calcium Carbonate

Manufacturer
Preferred Pharmaceuticals Inc.
Effective date
2018-04-03
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-02 01:00:23

Label at a glance#

ProductCalcium Carbonate (Antacid)
Active ingredientCALCIUM CARBONATE
Label structure8 sections

Indications and uses

for relief of • acid indigestion • heartburn • sour stomach • upset stomach associated with these symptoms

Storage and handling

• each tablet contains: calcium 260 mg • store at controlled room temperature 15 0 to 30 0 c (59 0 to 86 0 F) • use by expiration date on package

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Calcium carbonate 10 gr (648 mg, USP)

Purpose

OTC - PURPOSE SECTION

Antacid

Uses

INDICATIONS & USAGE SECTION

for relief of

  • acid indigestion
  • heartburn
  • sour stomach
  • upset stomach associated with these symptoms

Warnings

WARNINGS SECTION

Ask a doctor or pharmacist before use if

OTC - ASK DOCTOR/PHARMACIST SECTION

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

If pregnant or nursing a baby,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of the reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Direction

DOSAGE & ADMINISTRATION SECTION

  • take one to four tablets daily
  • do not take more than 4 tablets in a 24 hour period
  • do not use the maximum dosage for more than 2 weeks 

Other information

STORAGE AND HANDLING SECTION

  • each tablet contains: calcium 260 mg
  • store at controlled room temperature 150 to 300c (590 to 860F)
  • use by expiration date on package

Inactive ingredients

INACTIVE INGREDIENT SECTION

microcrystalline cellulose, croscarmellose sodium, stearic acid, magnesium stearate

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Calcium Carbonate 10gr. (648mg),
Calcium Carbonate 10gr. (648mg),

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
Data codeCode 39 Calcium Carbonate 648 mg Tablet Package Label.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68788-6343-62020-11-09C16284748780-19d75b9d0-2434-f424-e053-dadaa90a57ceDrug Facts
68788-6343-62020-01-31C16284748780-19d75b9d0-2434-f424-e053-dadaa90a57ceDrug Facts

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16103-377-08EA - Each16103-377629ba3f2-82bc-4623-85f1-cfe010b3a29812022-06-06
16103-377-11EA - Each16103-3776ccb1e2c-0f91-44f8-80f1-dc22040fcf6d12022-06-06

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68788-634368788-6343-6
16103-377

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
f52911a9-2a51-47c6-a7c2-43856122d444d32d1d8b-2b12-4e0f-b343-f9d4e7cbfafb2020-11-09WarningsExact identifier
spl set id: d32d1d8b-2b12-4e0f-b343-f9d4e7cbfafb

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.