FDA.reportPublic FDA data

antacid

Manufacturer
Rite Aid Corporation
Effective date
2018-06-29
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 00:53:24

Label at a glance#

Productantacid
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: calcium 430mg • store at 20-25 ° C (68-77 ° F) • does not meet USP for assay

Label contents#

Full prescribing information#

Active ingredient (in each 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: calcium 430mg
  • store at 20-25°C (68-77°F)
  • does not meet USP for assay

Inactive ingredients

INACTIVE INGREDIENT SECTION

dextrose, FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake, flavors, glycerin, magnesium stearate, maltodextrin, mineral oil

Questions?

OTC - QUESTIONS SECTION

1-800-719-9260

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to the active ingredient of Tums® Ultra Strength 1000

ULTRA STRENGTH

antacid

calcium carbonate 1000 mg

starts working in seconds

assorted berry flavors

fast relief of heartburn and acid indigestion

72 CHEWABLE TABLETS

antacid-imageantacid-image

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
11822-088111822-0881-1

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
CALCIUM CARBONATEH0G9379FGKACTIB
DEXTROSEIY9XDZ35W2IACT
MALTODEXTRIN7CVR7L4A2DIACT
MINERAL OILT5L8T28FGPIACT
GLYCERINPDC6A3C0OXIACT
MAGNESIUM STEARATE70097M6I30IACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C RED NO. 40WZB9127XOAIACT

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
f2a78280-93f5-4887-afa0-de7e7d2fd8a779f78617-e00c-4b90-97cc-a5f411bb86782020-11-11WarningsExact identifier
spl set id: 79f78617-e00c-4b90-97cc-a5f411bb8678

Reported adverse events (FAERS/openFDA)#

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