FDA.reportPublic FDA data

Topcare Ultra Strength Antacid Peppermint Chewable Tablets

Manufacturer
Topco Associates, LLC
Effective date
2024-12-11
Label type
Human OTC Drug Label
Version
2
Source
full-release
Hydrated at
2026-06-01 00:42:39

Label at a glance#

ProductTopcare Ultra Strength Antacid Peppermint
Active ingredientCALCIUM CARBONATE
Label structure12 sections

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.

Storage and handling

each tablet contains: elemental calcium 400 mg do not use if printed seal under the cap is torn or missing store at room temperature. keep the container tightly closed.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Calcium carbonate 1000 mg

PURPOSE

OTC - PURPOSE SECTION

Antacid

USE(S)

INDICATIONS & USAGE SECTION

relieves:

  • acid indigestion
  • heartburn

WARNINGS

WARNINGS SECTION

.

ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE

OTC - ASK DOCTOR/PHARMACIST 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 a 24-hour period, or use the maximum dosage of this product for more than 2 weeks, except under the advice and supervision of a doctor.

IF PREGNANT OR/BREASTFEEDING,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

.

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.

OTHER INFORMATION

STORAGE AND HANDLING SECTION

  • each tablet contains: elemental calcium 400 mg
  • do not use if printed seal under the cap is torn or missing
  • store at room temperature. keep the container tightly closed.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

corn starch, crospovidone, dextrose, flavor, magnesium stearate, maltodextrin, sucrose, talc.

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TopCare® health 
NDC 76162-131-68
COMPARE TO TUMS® ULTRA STRENTGH ACTIVE INGREDIENT*
ULTRA STRENGTH
Antacid Tablets
CALCIUM CARBONATE 1000 mg

RELIEVES:

  • Upset Stomach
  • Heartburn
  • Acid Indigestion

Peppermint Flavor
72 CHEWABLE TABLETS

171PPT-72171PPT-72

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308892calcium carbonate 1000 MG (Ca 400 MG) Chewable TabletPSN2
308892calcium carbonate 1000 MG Chewable TabletSCD2
308892calcium carbonate 1000 MG (calcium 400 MG) Chewable TabletSY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CALCIUM CATION Pharmacologic Class Indexing3Indexing - Pharmacologic Class20230427

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76162-131-68Topcare Ultra Strength Antacid Peppermint72 in 1 BOTTLETABLET, CHEWABLE722

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76162-131TOPCARE ULTRA STRENGTH ANTACID PEPPERMINT (CALCIUM CARBONATE) TABLET, CHEWABLE [TOPCO ASSOCIATES, LLC]2Current NDC, Legacy NDC, 1 package rows20241213_fb434059-7b6e-42e0-acfa-db9879f6a4e4.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76162-13176162-131-68

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
CALCIUM CARBONATEH0G9379FGKACTIB
STARCH, CORNO8232NY3SJIACT
DEXTROSE, UNSPECIFIED FORMIY9XDZ35W2IACT
MAGNESIUM STEARATE70097M6I30IACT
MALTODEXTRIN7CVR7L4A2DIACT
SUCROSEC151H8M554IACT
TALC7SEV7J4R1UIACT
CROSPOVIDONE2S7830E561IACT

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
Topcare Ultra Strength Antacid PeppermintCALCIUM CARBONATETopco Associates, LLCfb434059-7b6e-42e0-acfa-db9879f6a4e42024-12-11WarningsExact identifier
ndc (package): 76162-131-68
ndc (product): 76162-131
ndc11 (package): 76162013168
spl id: 47a0f780-1d28-4d5c-8344-f29fad84309d
spl set id: fb434059-7b6e-42e0-acfa-db9879f6a4e4

Reported adverse events (FAERS/openFDA)#

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