FDA.reportPublic FDA data

Topco Associates LLC. Antacid Calcium Drug Facts

Manufacturer
Topco Associates LLC.
Effective date
2026-11-12
Label type
HUMAN OTC DRUG LABEL
Version
12
Source
daily-update
Hydrated at
2026-11-14 03:02:25

Label at a glance#

ProductTopcare Antacid Calcium
Active ingredientCALCIUM CARBONATE
Label structure8 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 2-4 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

Label contents#

Full prescribing information#

Active ingredient (per tablet)

OTC - ACTIVE INGREDIENT SECTION

Calcium Carbonate USP 500mg

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

When using this product

  • do not take more than 15 tablets in 24 hours
  • if pregnant do not take more than 10 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 2-4 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

SPL UNCLASSIFIED SECTION

  • each tablet contains: elemental calcium 200mg
  • Store at room temperature. Keep the container tightly closed.

Inactive ingredients

INACTIVE INGREDIENT SECTION

adipic acid, D & C red # 27 lake, D&C yellow # 10 lake, dextrose, FD&C blue #1 lake, FD&C yellow #6 lake, flavors, magnesium stearate, maltodextrin, starch, sucralose.

Questions?

OTC - QUESTIONS SECTION

1-888-423-0139

Safety sealed: Do not use if printed seal under cap is torn or missing

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC # 36800-478-48

+ TopCare ® health TM

COMPARE TO REGULAR STRENGTH TUMS® ACTIVE INGREDIENT*

Regular Strength

Antacid Tablets

Calcium Carbonate 500 mg

FAST RELIEF OF:

  • Upset Stomach
  • Heartburn
  • Acid indigestion

ASSORTED FRUIT FLAVORS

150 CHEWABLE TABLETS

GLUTEN- FREE

QUALITY GUARANTEED

For questions or comments, please call

1-888-423-0139.

Distributed by: TOPCO ASSOCIATES LLC

  1. ELK GROVE VILLAGE, IL 6007
  2. © TOPCO RARA0918

QUESTIONS? 1-888-423-0139

topcare@topco.comwww.topcarebrand.com

Visit here for more information: topbrnds.com/48ZS0K

*This product is not manufactured or distributed by GlaxoSmithKline LLC, owner of the registered trademark, Regular Strength Tums®.

TopCare Regular Strength Antacid Calcium Carbonate Assorted Fruit
TopCare Regular Strength Antacid Calcium Carbonate Assorted Fruit

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bee4fa8d-8d82-423a-a0b5-40a89dd13a99Product name120250618
e0d2eb29-08bd-4bba-90d1-c91c68a38767Product name420250516
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
334fe8d2-68fb-4331-a576-420e302ec069Product name720240320
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
e92765c1-be81-432a-b909-1b10777ec378Product name120190208
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
0441a8f5-3835-497c-aedd-bc78cba56b2aProduct name120150317
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
36800-478-47EA - Each36800-478c043ff40-ca37-40eb-b819-e6c80fc8d8ac12012-07-24
36800-478-48EA - Each36800-47831268f09-6a4b-4803-827c-67c95bf401ea12024-04-05

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
36800-47836800-478-48

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
ADIPIC ACID76A0JE0FKJIACT
D&C RED NO. 272LRS185U6KIACT
D&C YELLOW NO. 1035SW5USQ3GIACT
DEXTROSE, UNSPECIFIED FORMIY9XDZ35W2IACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
MAGNESIUM STEARATE70097M6I30IACT
MALTODEXTRIN7CVR7L4A2DIACT
STARCH, CORNO8232NY3SJIACT
SUCRALOSE96K6UQ3ZD4IACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
112025-11-08full-release2026-06-01 01:42:57
102024-11-06full-release2026-06-01 00:34:33

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 Antacid CalciumCALCIUM CARBONATETopco Associates LLC.bb99b942-1f84-43e1-a18d-3a975cddc59e2025-11-08WarningsExact identifier
ndc (package): 36800-478-48
ndc (product): 36800-478
ndc11 (package): 36800047848
spl set id: bb99b942-1f84-43e1-a18d-3a975cddc59e

Reported adverse events (FAERS/openFDA)#

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