FDA.reportPublic FDA data

Ultra Strength Antacid Calcium Carbonate Chewable Tablets

Manufacturer
Wal-Mart Stores,Inc.,
Effective date
2019-12-04
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:01:45

Label at a glance#

ProductUltra Strength Antacid Assorted Fruit
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 2-3 tablets 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 1000mg

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 7 tablets in 24 hours
  • if pregnant do not take more than 5 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 2-3 tablets 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 400mg
  • Store at room temperature. Keep the container tightly closed.

Inactive ingredients

INACTIVE INGREDIENT SECTION

adipic acid, D&C Red No. 27 Lake, D&C Yellow No. 10 Lake, dextrose, FD&C Blue No. 1 Lake, FD&C Yellow No. 6 Lake, flavors, magnesium stearate, maltodextrin, starch, sucralose.

Questions?

OTC - QUESTIONS SECTION

1-866-467-2748

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 49035-169-16

equate™

Compare to the active ingredient in Ultra Strength Tums®

ULTRA STRENGTH

Antacid Tablets

Calcium Carbonate 1000 mg

Fast Relief of Upset Stomach, Heartburn and Acid Indigestion

Assorted Fruit Flavors

Naturally and Artificially Flavored

160 CHEWABLE TABLETS

Gluten- Free

Satisfaction guaranteed-

For questions or comments, please call

1-888-287-1915.

Distributed by: Wal-Mart Stores, Inc.,

Bentonville,AR 72716

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

Twin Pack Ultra Strength Antacid Tablets
Twin Pack Ultra Strength Antacid Tablets

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308892calcium carbonate 1000 MG (Ca 400 MG) Chewable TabletPSN2
308892calcium carbonate 1000 MG Chewable TabletSCD2
308892calcium carbonate 1000 MG (calcium 400 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49035-169-162021-01-29C16284748780-1ba0f9c33-4878-a910-e053-dadaa90a0b85Ultra Strength Antacid Calcium Carbonate Chewable Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49035-169-16Ultra Strength AntacidAssorted Fruit160 in 1 BOTTLE, PLASTICTABLET, CHEWABLE1602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49035-169ULTRA STRENGTH ANTACID ASSORTED FRUIT (CALCIUM CARBONATE) TABLET, CHEWABLE [WAL-MART STORES,INC.,]2Legacy NDC, 1 package rows20191205_a1021774-4d7a-4e44-807e-95103aa82c40.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
49035-16949035-169-16

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
392a5b60-c186-49e1-879f-9d67de93a6e1a1021774-4d7a-4e44-807e-95103aa82c402019-12-04WarningsExact identifier
spl id: 392a5b60-c186-49e1-879f-9d67de93a6e1
spl set id: a1021774-4d7a-4e44-807e-95103aa82c40

Reported adverse events (FAERS/openFDA)#

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