FDA.reportPublic FDA data

Publix ® Extra Strength Assorted Fruits 96 Chewable Tablets

Manufacturer
PUBLIX SUPER MARKETS, INC
Effective date
2021-11-09
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:44:51

Label at a glance#

ProductPublix Extra Strength Assorted Fruit
Active ingredientCALCIUM CARBONATE
Label structure8 sections

Indications and uses

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

Dosage and administration

• adults and children 12 years of age and over: chew 2-4 tablets completely as symptoms occur, or as directed by a doctor. Do not swallow tablets whole. • 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 750mg

Purpose

OTC - PURPOSE SECTION

Antacid

Uses

INDICATIONS & USAGE SECTION

relieves

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

Warnings

WARNINGS SECTION

Ask a doctor or pharmacist before use if you are presentlytaking a prescription drug. Antacids may interact with certain prescription drugs.

When using this product

  • do not take more than 10 tablets in 24 hours
  • if pregnant do not take more than 6 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 completely as symptoms occur, or as directed by a doctor. Do not swallow tablets whole.
  • 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 300mg
  • store at room temperature. Keep the container tightly closed

SAFETY SEALED: Do not use if printed seal under cap is torn or missing

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 or comments?

OTC - QUESTIONS SECTION

1-888-267-3037

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Publix®

NDC# 41415-200-96

Compare to the active ingredients in Tums® Extra Strength 750 Assorted Fruit Flavor

extra strength

CALCIUM CARBONATE 750 mg/ ANTACID

ASSORTED FRUIT

Natural and Artificially Flavored

96 CHEWABLE TABLETS

GLUTEN-FREE

DISTRIBUTED BY:

PUBLIX SUER MARKETS, INC.,

LAKELAND, FL 33811 publix.com

1-888-267-3037

PUBLIX GUARANTEE: COMPLETE SATISFACTION OR YOUR MONEY BACK

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

Extra Strength Calcium Carbonate Antacid Tablets
Extra Strength Calcium Carbonate Antacid Tablets

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308915calcium carbonate 750 MG (Ca 300 MG) Chewable TabletPSN3
308915calcium carbonate 750 MG Chewable TabletSCD3
308915calcium carbonate 750 MG (calcium 300 MG) Chewable TabletSY3

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
41415-200-962023-01-30C16284748780-1f386c649-f66c-0266-e053-dadaa90a7c1aPublix ® Extra Strength Assorted Fruits 96 Chewable Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41415-200-96Publix Extra StrengthAssorted Fruit96 in 1 BOTTLE, PLASTICTABLET, CHEWABLE963

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41415-200PUBLIX EXTRA STRENGTH ASSORTED FRUIT (CALCIUM CARBONATE) TABLET, CHEWABLE [PUBLIX SUPER MARKETS, INC]3Legacy NDC, 1 package rows20211110_e9dbb005-c78a-440d-bd7c-5b4d64fa2a21.zip

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
41415-20041415-200-96

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

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
b3196fa5-3dd9-431c-abb1-30c89be07a35e9dbb005-c78a-440d-bd7c-5b4d64fa2a212021-11-09WarningsExact identifier
spl id: b3196fa5-3dd9-431c-abb1-30c89be07a35
spl set id: e9dbb005-c78a-440d-bd7c-5b4d64fa2a21

Reported adverse events (FAERS/openFDA)#

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