FDA.reportPublic FDA data

topcare Antacid Calcium

Manufacturer
Topco Associates LLC
Effective date
2019-12-02
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 23:56:27

Label at a glance#

Producttopcare Antacid Calcium Ultra Strength
Active ingredientCALCIUM CARBONATE
Label structure9 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

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 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

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
  • 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

citric acid, dextrose, FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake, FD&C yellow #5 aluminum lake (tartrazine), FD&C yellow #6 aluminum lake, flavors, glycerin, magnesium stearate, maltodextrin, mineral oil

Questions?

OTC - QUESTIONS SECTION

1-888-423-0139

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

ASSORTED FRUIT FLAVORS

72 CHEWABLE TABLETS

K PAREVE

antacid calcium image
antacid calcium image

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
36800-595-23EA - Each36800-595f9184b09-d688-49bd-8b15-b029503cbbe012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CALCIUM CARBONATEACTIVE INGREDIENTH0G9379FGK2
CALCIUM CATIONACTIVE MOIETY2M83C4R6ZB2
ADIPIC ACIDINACTIVE INGREDIENT76A0JE0FKJ2
DEXTROSEINACTIVE INGREDIENTIY9XDZ35W22
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2D2
MINERAL OILINACTIVE INGREDIENTT5L8T28FGP2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1A2
POWDERED CELLULOSEINACTIVE INGREDIENTSMD1X3XO9M2
TALCINACTIVE INGREDIENT7SEV7J4R1U2

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
36800-59536800-595-23

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
CALCIUM CARBONATEH0G9379FGKACTIB
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
GLYCERINPDC6A3C0OXIACT
MAGNESIUM STEARATE70097M6I30IACT
MALTODEXTRIN7CVR7L4A2DIACT
MINERAL OILT5L8T28FGPIACT
DEXTROSEIY9XDZ35W2IACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C RED NO. 40WZB9127XOAIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
FD&C YELLOW NO. 6H77VEI93A8IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 14 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
TALCTALC7SEV7J4R1UTABLET, CHEWABLE / ORAL202 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPTABLET, CHEWABLE / ORAL6 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
DEXTROSEDEXTROSEIY9XDZ35W2TABLET, CHEWABLE / ORAL1286 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
ADIPIC ACIDADIPIC ACID76A0JE0FKJINSERT / VAGINAL171 mgExact identifier — unii candidate
4 equally ranked IID candidates
ADIPIC ACIDADIPIC ACID76A0JE0FKJINJECTION / INTRAMUSCULAR1 %w/vExact identifier — unii candidate
4 equally ranked IID candidates
ADIPIC ACIDADIPIC ACID76A0JE0FKJINJECTION / INTRAMUSCULAR1 %w/vExact identifier — unii candidate
4 equally ranked IID candidates
POWDERED CELLULOSEPOWDERED CELLULOSESMD1X3XO9MTABLET, CHEWABLE / ORALNAExact identifier — unii+route+dosage form
2 equally ranked IID candidates
POWDERED CELLULOSEPOWDERED CELLULOSESMD1X3XO9MTABLET, CHEWABLE / ORALNAExact identifier — unii+route+dosage form
2 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPTABLET, CHEWABLE / ORAL6 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
DEXTROSEDEXTROSEIY9XDZ35W2TABLET, CHEWABLE / ORAL1286 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DTABLET, CHEWABLE / ORAL292 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
ADIPIC ACIDADIPIC ACID76A0JE0FKJINSERT / VAGINAL171 mgExact identifier — unii candidate
4 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DTABLET, CHEWABLE / ORAL292 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
TALCTALC7SEV7J4R1UTABLET, CHEWABLE / ORAL202 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates

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 Calcium Ultra StrengthCALCIUM CARBONATETopco Associates LLC6e2788b3-1e33-4908-aa2c-475d69b94ee62025-11-08WarningsExact identifier
ndc (product): 36800-595
e08e2500-9251-4168-8a40-043b1aaa1749f930326f-0159-461f-8e8c-78cef4b075cf2020-12-14WarningsExact identifier
spl set id: f930326f-0159-461f-8e8c-78cef4b075cf

Reported adverse events (FAERS/openFDA)#

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