FDA.reportPublic FDA data

Topcare Extra Strength Antacid Assorted Fruit

Manufacturer
Topco Associates, LLC
Effective date
2024-12-09
Label type
Human OTC Drug Label
Version
2
Source
full-release
Hydrated at
2026-06-01 00:41:57

Label at a glance#

ProductTopcare Extra Strength Antacid Assorted Fruit Extra Strength Antacid Assorted Fruit
Active ingredientCALCIUM CARBONATE
Label structure12 sections

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.

Storage and handling

each tablet contains: elemental calcium 300 mg do not use if printed seal under 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 750 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 10 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 2-4 tablets as symptoms occur, or as directed by a doctor.

OTHER INFORMATION

STORAGE AND HANDLING SECTION

  • each tablet contains: elemental calcium 300 mg
  • do not use if printed seal under cap is torn or  missing. 
  • store at room temperature. Keep the container tightly closed.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

adipic acid, corn starch, crospovidone, D&C red 27 lake, D&C red 30 lake, D&C yellow 10 lake, dextrose, FD&C blue 1 lake, FD&C yellow 6 lake, flavors, magnesium stearate, maltodextrin, sucrose, talc.

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TopCare® health

NDC 76162-127-22

COMPARE TO TUMS® EXTRA STRENGTH ACTIVE INGREDIENT*

Extra Strength
Antacid Tablets
CALCIUM CARBONATE

750 mg

RELIEVES :

  • Upset Stomach
  • Heartburn
  • Acid Indigestion

ASSORTED FRUIT FLAVORS

96 CHEWABLE TABLETS

127af-topco.jpg127af-topco.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308915calcium carbonate 750 MG (Ca 300 MG) Chewable TabletPSN2
308915calcium carbonate 750 MG Chewable TabletSCD2
308915calcium carbonate 750 MG (calcium 300 MG) Chewable TabletSY2

DailyMed Pharmacologic Classes#

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

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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76162-127-22Topcare Extra Strength Antacid Assorted FruitExtra Strength Antacid Assorted Fruit96 in 1 BOTTLETABLET, CHEWABLE962

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76162-127TOPCARE EXTRA STRENGTH ANTACID ASSORTED FRUIT EXTRA STRENGTH ANTACID ASSORTED FRUIT (CALCIUM CARBONATE) TABLET, CHEWABLE [TOPCO ASSOCIATES, LLC]2Current NDC, Legacy NDC, 1 package rows20241212_563a9951-0d40-448b-bf0d-8f6d905087d0.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76162-12776162-127-22

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
CALCIUM CARBONATEH0G9379FGKACTIB
ADIPIC ACID76A0JE0FKJIACT
STARCH, CORNO8232NY3SJIACT
CROSPOVIDONE2S7830E561IACT
DEXTROSE, UNSPECIFIED FORMIY9XDZ35W2IACT
FD&C BLUE NO. 1H3R47K3TBDIACT
MAGNESIUM STEARATE70097M6I30IACT
MALTODEXTRIN7CVR7L4A2DIACT
SUCROSEC151H8M554IACT
TALC7SEV7J4R1UIACT
D&C RED NO. 272LRS185U6KIACT
D&C RED NO. 302S42T2808BIACT
D&C YELLOW NO. 1035SW5USQ3GIACT
FD&C YELLOW NO. 6H77VEI93A8IACT

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 Extra Strength Antacid Assorted Fruit Extra Strength Antacid Assorted FruitCALCIUM CARBONATETopco Associates, LLC563a9951-0d40-448b-bf0d-8f6d905087d02024-12-09WarningsExact identifier
ndc (package): 76162-127-22
ndc (product): 76162-127
ndc11 (package): 76162012722
spl id: a8bc872b-3cd1-4beb-8848-275f2a3747e7
spl set id: 563a9951-0d40-448b-bf0d-8f6d905087d0

Reported adverse events (FAERS/openFDA)#

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