FDA.reportPublic FDA data

Extra Strength Antacid Smooth Dissolve Assorted Fruit

Manufacturer
UNITED NATURAL FOODS, INC. DBA UNFI | Guardian Drug Company
Effective date
2024-12-11
Label type
Human OTC Drug Label
Version
2
Source
full-release
Hydrated at
2026-06-01 00:42:14

Label at a glance#

ProductExtra Strength Antacid Smooth Dissolve 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 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 BREAST FEEDING,

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
  • store at room temperature. keep the container tightly closed.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

adipic acid, corn starch, D&C red 30 lake, D&C yellow 10 lake, dextrose, FD&C blue 1 lake, FD&C red 40 lake, FD&C yellow 6 lake, flavors, magnesium stearate, maltodextrin, microcrystalline cellulose, sorbitol, sucrose, talc.

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DC 83455-173-23

Compare to Tums® SmoothiesTM Extra Strength 750 active ingredient*

EQUALINE®

extra strength
antacid tablets

Calcium Carbonate 750 mg

smooth dissolve

relieves

heartburn and acid indigestion

assorted fruit flavors

60 CHEWABLE TABLETS

173af-f.jpg173af-f.jpg

173af-b.jpg173af-b.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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83455-173-23Extra Strength Antacid Smooth Dissolve Assorted Fruit60 in 1 BOTTLETABLET, CHEWABLE602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83455-173EXTRA STRENGTH ANTACID SMOOTH DISSOLVE ASSORTED FRUIT (CALCIUM CARBONATE) TABLET, CHEWABLE [UNITED NATURAL FOODS, INC. DBA UNFI]2Current NDC, 1 package rows20241213_1b6a48a7-0703-2d3d-e063-6394a90a4641.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
83455-17383455-173-23

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
DEXTROSE, UNSPECIFIED FORMIY9XDZ35W2IACT
FD&C BLUE NO. 1 ALUMINUM LAKEJ9EQA3S2JMIACT
FD&C RED NO. 40 ALUMINUM LAKE6T47AS764TIACT
MAGNESIUM STEARATE70097M6I30IACT
MALTODEXTRIN7CVR7L4A2DIACT
SUCROSEC151H8M554IACT
TALC7SEV7J4R1UIACT
SORBITOL506T60A25RIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
D&C RED NO. 30 ALUMINUM LAKEGE75M6YV5WIACT
D&C YELLOW NO. 10 ALUMINUM LAKECQ3XH3DET6IACT

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
Extra Strength Antacid Smooth Dissolve Assorted FruitCALCIUM CARBONATEUNITED NATURAL FOODS, INC. DBA UNFI1b6a48a7-0703-2d3d-e063-6394a90a46412024-12-11WarningsExact identifier
ndc (package): 83455-173-23
ndc (product): 83455-173
ndc11 (package): 83455017323
spl id: 9679dcb5-30b5-4a03-adda-04eeb66ecb1f
spl set id: 1b6a48a7-0703-2d3d-e063-6394a90a4641

Reported adverse events (FAERS/openFDA)#

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