FDA.reportPublic FDA data

Ultra Strength

Manufacturer
SAM'S WEST INC
Effective date
2025-11-20
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 01:17:23

Label at a glance#

ProductUltra Strength Assorted Berries
Active ingredientCALCIUM CARBONATE
Label structure10 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 take for symptoms that persist for more than 2 weeks unless advised by a doctor

Storage and handling

each tablet contains: elemental calcium 400mg Store at room temperature

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

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 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 take for symptoms that persist for more than 2 weeks unless advised by a doctor

Other information

STORAGE AND HANDLING SECTION

  • each tablet contains: elemental calcium 400mg
  • Store at room temperature

Inactive ingredients

INACTIVE INGREDIENT SECTION

adipic acid, blue 1 lake, dextrose, flavors, magnesium stearate, red 40 lake, starch, sucralose.

Questions or comments?

OTC - QUESTIONS SECTION

1-888-301-0332

Safety Sealed:

OTC - DO NOT USE SECTION

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

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Member’s Mark ™

COMPARE TO TUMS ®Ultra Strength active ingredient*

ULTRA STRENGTH 1000

ANTACID TABLETS

Calcium Carbonate

Assorted Berry Flavors

Naturally and Artificially Flavored

GLUTEN FREE

K PAREVE

DISTRIBUTED BY SAM’S WEST, INC.

BENTONVILLE, AR 72716

For comments or suggestions, call us toll-free at 1.888-301-0332 from 8 a.m. to 5 p.m. CST Monday-Friday

*This product is not manufactured or distributed by GlaxoSmithKline, the distributor of Tums®.

Package Label 265 Chewable Tablets

SAM'S West Ultra Strength 1000 Antacid 265 Tablets
SAM'S West Ultra Strength 1000 Antacid 265 Tablets

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308892calcium carbonate 1000 MG (Ca 400 MG) Chewable TabletPSN7
308892calcium carbonate 1000 MG Chewable TabletSCD7
308892calcium carbonate 1000 MG (calcium 400 MG) Chewable TabletSY7

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
68196-103-65Ultra StrengthAssorted Berries265 in 1 BOTTLETABLET, CHEWABLE2657

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68196-10368196-103-65

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
ADIPIC ACID76A0JE0FKJIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
DEXTROSE, UNSPECIFIED FORMIY9XDZ35W2IACT
MAGNESIUM STEARATE70097M6I30IACT
MALTODEXTRIN7CVR7L4A2DIACT
FD&C RED NO. 40WZB9127XOAIACT
STARCH, CORNO8232NY3SJIACT
SUCRALOSE96K6UQ3ZD4IACT
CALCIUM CARBONATEH0G9379FGKACTIB

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
Ultra Strength Assorted BerriesCALCIUM CARBONATESAM'S WEST INCbc619258-7451-460c-9472-95678ea82d6e2025-11-20WarningsExact identifier
ndc (package): 68196-103-65
ndc (product): 68196-103
ndc11 (package): 68196010365
spl id: 44064fb5-e380-5c71-e063-6394a90a5300
spl set id: bc619258-7451-460c-9472-95678ea82d6e

Reported adverse events (FAERS/openFDA)#

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