FDA.reportPublic FDA data

Extra Strength Smooth Antacid

Manufacturer
Thirty Madison Inc
Effective date
2022-01-06
Label type
Human OTC Drug Label
Version
3
Source
full-release
Hydrated at
2026-05-31 23:46:26

Label at a glance#

ProductExtra Strength Smooth Antacid
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. do not take for symptoms that persists for more than 2 weeks unless advised 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
  • 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 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.
  • do not take for symptoms that persists for more than 2 weeks unless advised 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, dextrose, FD&C blue 1 lake, FD&C red 40 lake, flavors, magnesium stearate, maltodextrin, microcrystalline cellulose, sorbitol, sucrose, talc.

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Extra Strength
Smooth
Antacid Tablets
evens
Chill Berries 
Calcium Carbonate 750 mg

60 Chewable Tablets

Compare to the active ingredient  in TUMS®SmoothiesTM EX



44
44

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
71713-204-032024-01-30C16284748780-11030e365-0286-111a-e063-dadaa90a10e2Extra Strength Smooth Antacid Chill Berries

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71713-204-03Extra Strength Smooth Antacid60 in 1 BOTTLETABLET, CHEWABLE603

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71713-204EXTRA STRENGTH SMOOTH ANTACID (CALCIUM CARBONATE) TABLET, CHEWABLE [THIRTY MADISON INC]3Legacy NDC, 1 package rows20220107_95fcaed0-b761-4e6e-a1a6-184dc3ba0548.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71713-204-03EA - Each71713-204fb2b7abc-cfbd-44f4-a1b1-4a9d79c4e4ab12022-06-06

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
71713-20471713-204-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
CALCIUM CARBONATEH0G9379FGKACTIB
ADIPIC ACID76A0JE0FKJIACT
STARCH, CORNO8232NY3SJIACT
DEXTROSE, UNSPECIFIED FORMIY9XDZ35W2IACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C RED NO. 40WZB9127XOAIACT
MAGNESIUM STEARATE70097M6I30IACT
MALTODEXTRIN7CVR7L4A2DIACT
SUCROSEC151H8M554IACT
TALC7SEV7J4R1UIACT
SORBITOL506T60A25RIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT

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
966f739d-4d4c-40aa-add8-430fa7f3654f95fcaed0-b761-4e6e-a1a6-184dc3ba05482022-01-06WarningsExact identifier
spl id: 966f739d-4d4c-40aa-add8-430fa7f3654f
spl set id: 95fcaed0-b761-4e6e-a1a6-184dc3ba0548

Reported adverse events (FAERS/openFDA)#

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