FDA.reportPublic FDA data

Extra Strength Antacid Assorted Berries 60 Chewable Tablets

Manufacturer
RITE AID CORPORATION
Effective date
2024-10-30
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:31:51

Label at a glance#

ProductExtra Strength Smooth Antacid
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 2-4 tablets completely as symptoms occur, or as directed by a doctor. Do not swallow the 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
  • 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 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 the 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

Inactive ingredients

INACTIVE INGREDIENT SECTION

adipic acid, dextrose, FD&C Blue No. 1 Lake, FD&C Red No. 40 Lake, flavors, magnesium stearate, maltodextrin, starch, sucralose.

Questions?

OTC - QUESTIONS SECTION

1-866-467-2748

DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC# 11822-1166-0

Compare to the active ingredient in Extra Strength Tums® Smoothies™

EXTRA STRENGTH

Smooth Antacid Tablets

Calcium Carbonate 750 mg

Fas Relief of Upset Stomach, Heartburn and Acid Indigestion

Assorted Berries

Naturally and Artificially Flavored

60 Chewable Tablets

K PAREVE

GLUTEN- FREE

DISTRIBUTED BY:

RITE AID, 30 HUNTER LANE

CAMP HILL, PA 17011

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

Extra Strength Smooth Antacid 60 Chewable Tablets
Extra Strength Smooth Antacid 60 Chewable Tablets

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308915calcium carbonate 750 MG (Ca 300 MG) Chewable TabletPSN5
308915calcium carbonate 750 MG Chewable TabletSCD5
308915calcium carbonate 750 MG (calcium 300 MG) Chewable TabletSY5

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
11822-1166-02021-06-24C16284748780-1ba0f9c33-5cfa-a910-e053-dadaa90a0b85Extra Strength Antacid Assorted Berries 60 Chewable Tablets
11822-1166-02021-01-29C16284748780-1ba0f9c33-5cfa-a910-e053-dadaa90a0b85Extra Strength Antacid Assorted Berries 60 Chewable Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11822-1166-0Extra Strength SmoothAntacid60 in 1 BOTTLE, PLASTICTABLET, CHEWABLE605

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-1166EXTRA STRENGTH SMOOTH ANTACID (CALCIUM CARBONATE) TABLET, CHEWABLE [RITE AID CORPORATION]5Current NDC, Legacy NDC, 1 package rows20241101_23fa3378-d9f9-4671-ba1c-9c9611b1fbef.zip

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
11822-116611822-1166-0

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
CALCIUM CARBONATEH0G9379FGKACTIB
ADIPIC ACID76A0JE0FKJIACT
DEXTROSE, UNSPECIFIED FORMIY9XDZ35W2IACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C RED NO. 40WZB9127XOAIACT
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
Extra Strength Smooth AntacidCALCIUM CARBONATERITE AID CORPORATION23fa3378-d9f9-4671-ba1c-9c9611b1fbef2024-10-30WarningsExact identifier
ndc (package): 11822-1166-0
ndc (product): 11822-1166
ndc11 (package): 11822116600
spl id: 75329889-3fd6-4be0-99e5-69ac9e0f070b
spl set id: 23fa3378-d9f9-4671-ba1c-9c9611b1fbef

Reported adverse events (FAERS/openFDA)#

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