FDA.reportPublic FDA data

Extra Strength SUGAR FREE Antacid Tablets Calcium Carbonate 750 mg

Manufacturer
Raritan Pharmaceuticals Inc
Effective date
2022-01-14
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:46:53

Label at a glance#

ProductExtra Strength Sugar Free Orange Cream Flavor
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 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

Label contents#

Full prescribing information#

Active ingredient (per tablet)

OTC - ACTIVE INGREDIENT SECTION

Calcium Carbonate USP 750 mg

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 9 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 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

SPL UNCLASSIFIED SECTION

  • each tablet contains: elemental calcium 300 mg
  • store below 30°C (86°F).

Inactive ingredients

INACTIVE INGREDIENT SECTION

adipic acid, flavors, magnesium stearate, maltodextrin, sorbitol, starch, sucralose, FD&C Yellow No. 6 lake.

Questions or comments?

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 68163-202-90

DRxCHOICE®

Compare to Tums® active ingredient*

EXTRA STRENGTH

Antacid

Tablets

Calcium Carbonate USP 750 mg

Sugar-Free

  • Relieves:
  • Acid Indigestion
  • Sour Stomach

90 CHEWABLE TABLETS

K PARVE

Distributed by:

Raritan Pharmaceuticals

8 Joanna Court, East Brunswick, NJ 08816

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

DRx Choice Extra Strength Antacid 90 CT Orange Cream Flavor
DRx Choice Extra Strength Antacid 90 CT Orange Cream Flavor

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
68163-202-902024-01-30C16284748780-11030e365-3f95-111a-e063-dadaa90a10e2Extra Strength SUGAR FREE Antacid Tablets Calcium Carbonate 750 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68163-202-90Extra Strength Sugar FreeOrange Cream Flavor90 in 1 BOTTLE, PLASTICTABLET, CHEWABLE903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68163-202EXTRA STRENGTH SUGAR FREE ORANGE CREAM FLAVOR (CALCIUM CARBONATE) TABLET, CHEWABLE [RARITAN PHARMACEUTICALS INC]3Legacy NDC, 1 package rows20220115_50d9e7a4-79b8-4315-8717-0f416541fc01.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68163-20268163-202-90

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
CALCIUM CARBONATEH0G9379FGKACTIB
ADIPIC ACID76A0JE0FKJIACT
MAGNESIUM STEARATE70097M6I30IACT
MALTODEXTRIN7CVR7L4A2DIACT
SORBITOL506T60A25RIACT
STARCH, CORNO8232NY3SJIACT
SUCRALOSE96K6UQ3ZD4IACT
FD&C YELLOW NO. 6H77VEI93A8IACT

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
31027601-34d0-4291-ab50-03500ed7c8f550d9e7a4-79b8-4315-8717-0f416541fc012022-01-14WarningsExact identifier
spl id: 31027601-34d0-4291-ab50-03500ed7c8f5
spl set id: 50d9e7a4-79b8-4315-8717-0f416541fc01

Reported adverse events (FAERS/openFDA)#

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