FDA.reportPublic FDA data

Extra Strength Antacid Orange Cream Sugar Free

Manufacturer
Rite Aid | Medical Group Care LLC
Effective date
2025-03-28
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:58:05

Label at a glance#

ProductExtra Strength Antacid Orange Cream Sugar Free
Active ingredientCALCIUM CARBONATE
Label structure9 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, 2 times daily 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 (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Calcium carbonate 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

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 24 hours.
  • do not use the maximum dosage of this product for more than 2 weeks except under advice and supervision of a doctor
  • if pregnant do not take more than 5 tablets in 24 hours.

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, completely as symptoms occur, 2 times daily 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

OTHER SAFETY INFORMATION

  • each tablet contains:calcium 300 mg
  • store at room temperature (20-25°C (68-75°F)). Keep the container tightly closed.
  • do not use if printed seal under cap is torn or missing.

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

+1-866-306-9136
You may also report serious side effects to this phone
number.Mon-Fri 9:00 AM - 5:00 PM Eastern Time.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308915calcium carbonate 750 MG (Ca 300 MG) Chewable TabletPSN1
308915calcium carbonate 750 MG Chewable TabletSCD1
308915calcium carbonate 750 MG (calcium 300 MG) Chewable TabletSY1

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
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11822-3542-1Extra Strength Antacid Orange Cream Sugar Free90 in 1 PACKAGETABLET901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-3542EXTRA STRENGTH ANTACID ORANGE CREAM SUGAR FREE (CALCIUM CARBONATE) TABLET [RITE AID]1Current NDC, 1 package rows20250331_089a1cd5-954e-4c3f-ab4b-cac693a1d44a.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11822-354211822-3542-1

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
STARCH, CORNO8232NY3SJIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
ADIPIC ACID76A0JE0FKJIACT
MAGNESIUM STEARATE70097M6I30IACT
MALTODEXTRIN7CVR7L4A2DIACT
SUCRALOSE96K6UQ3ZD4IACT
SORBITOL506T60A25RIACT
CALCIUM CARBONATEH0G9379FGKACTIM

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 Antacid Orange Cream Sugar FreeCALCIUM CARBONATERite Aid089a1cd5-954e-4c3f-ab4b-cac693a1d44a2025-03-28WarningsExact identifier
ndc (package): 11822-3542-1
ndc (product): 11822-3542
ndc11 (package): 11822354201
spl id: 3168eb97-ddd9-fbfc-e063-6294a90a01e2
spl set id: 089a1cd5-954e-4c3f-ab4b-cac693a1d44a

Reported adverse events (FAERS/openFDA)#

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