FDA.reportPublic FDA data

Topcare antacid calcium

Manufacturer
Topco Associates LLC
Effective date
2018-06-27
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 00:53:24

Label at a glance#

ProductTopcare antacid calcium
Active ingredientCALCIUM CARBONATE
Label structure10 sections

Indications and uses

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

Dosage and administration

• adults and children 12 years of age and over: chew 2-3 tablets as symptoms occur, or as directed by a doctor • do not take for symptoms that persist for more than 2 weeks unless advised by a doctor

Storage and handling

• each tablet contains: calcium 430mg • store at 20-25 ° C (68-77 ° F) • does not meet USP for assay

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Calcium carbonate USP 1000mg

Purpose

OTC - PURPOSE SECTION

Antacid

Uses

INDICATIONS & USAGE SECTION

relieves

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

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR SECTION

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

When using this product

OTC - WHEN USING SECTION

  • do not take more than 7 tablets in 24 hours
  • if pregnant do not take more than 5 tablets in 24 hours
  • do not use the maximum dosage for more than 2 weeks except under the advice and supervision of a doctor

Directions

DOSAGE & ADMINISTRATION SECTION

  • adults and children 12 years of age and over: chew 2-3 tablets as symptoms occur, or as directed by a doctor
  • do not take for symptoms that persist for more than 2 weeks unless advised by a doctor

Other information

STORAGE AND HANDLING SECTION

  • each tablet contains: calcium 430mg
  • store at 20-25°C (68-77°F)
  • does not meet USP for assay

Inactive ingredients

INACTIVE INGREDIENT SECTION

dextrose, flavor, glycerin, magnesium stearate, maltodextrin, mineral oil

Questions?

OTC - QUESTIONS SECTION

1-888-423-0139

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

COMPARE TO TUMS® ULTRA STRENGTH 1000 ACTIVE INGREDIENT

ULTRA STRENGTH

Antacid Calcium

CALCIUM CARBONATE 1000 mg

OUR PHARMACISTS RECOMMEND

Starts Working in Seconds

PEPPERMINT FLAVOR

72 CHEWABLE TABLETS

K PAREVE

antacid-calcium-image
antacid-calcium-image

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
36800-96236800-962-23

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
CALCIUM CARBONATEH0G9379FGKACTIB
DEXTROSEIY9XDZ35W2IACT
MALTODEXTRIN7CVR7L4A2DIACT
MINERAL OILT5L8T28FGPIACT
GLYCERINPDC6A3C0OXIACT
MAGNESIUM STEARATE70097M6I30IACT

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Topcare antacid calciumCALCIUM CARBONATETopco Associates LLCad001c7f-cd3f-4577-a793-50055e4327472025-11-08WarningsExact identifier
ndc (product): 36800-962
2c634477-ecc8-4287-b8c5-b68fcb401e831722e68b-9e57-4bcd-9baa-19453c83497e2021-05-10WarningsExact identifier
spl set id: 1722e68b-9e57-4bcd-9baa-19453c83497e

Reported adverse events (FAERS/openFDA)#

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