FDA.reportPublic FDA data

Ultra Strength Antacid Assorted Fruit

Manufacturer
Rite Aid | Medical Group Care LLC
Effective date
2025-03-31
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 20:39:55

Label at a glance#

ProductUltra Strength Antacid Assorted Fruit
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 8 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.
  • Contains FD&C Yellow No. 5 (Tartrazine) as a color additive

Inactive ingredients

INACTIVE INGREDIENT SECTION

corn starch, FD&C Blue No.1, FD&C Red No. 40, FD&C Yellow No. 5, FD&C Yellow No. 6, flavors, magnesium stearate, maltitol, sucralose, sucrose

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

Assorted Fruit 160Assorted Fruit 160

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-3580ULTRA STRENGTH ANTACID ASSORTED FRUIT (CALCIUM CARBONATE) TABLET [RITE AID]1Unmatched20250409_d1bd3320-a677-45fb-bfe6-2297cb124967.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
11822-358011822-3580-1, 11822-3580-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
STARCH, CORNO8232NY3SJIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C RED NO. 40WZB9127XOAIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
MAGNESIUM STEARATE70097M6I30IACT
MALTITOLD65DG142WKIACT
SUCRALOSE96K6UQ3ZD4IACT
SUCROSEC151H8M554IACT
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
3635810a-bd5d-9329-e063-6394a90a8f3fd1bd3320-a677-45fb-bfe6-2297cb1249672025-05-28WarningsExact identifier
spl set id: d1bd3320-a677-45fb-bfe6-2297cb124967

Reported adverse events (FAERS/openFDA)#

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