FDA.reportPublic FDA data

Calcium Carbonate

Manufacturer
REMEDYREPACK INC.
Effective date
2021-11-08
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 22:28:57

Label at a glance#

ProductCalcium Carbonate
Active ingredientCALCIUM CARBONATE
Label structure12 sections

Indications and uses

Use for the prevention of calcium deficiency in adults.

Dosage and administration

Shake well before using. Take 5 mL (one teaspoonful) two to three times daily with meals or as directed by a physician.

Storage and handling

Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Keep from freezing. Sodium content: 0 mg per 5 mL

Label contents#

Full prescribing information#

CALCIUM CARBONATE Oral Suspension (not USP)

SPL UNCLASSIFIED SECTION

Calcium Supplement

Supplement Facts

SPL UNCLASSIFIED SECTION

Serving Size: 5 mL (teaspoonful)

Amount Per Serving

% Daily Value

Calcium 500 mg

50 %

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Each 5 mL (teaspoonful) delivers 1250 mg calcium carbonate (equivalent to 500 mg elemental calcium).

Purpose

OTC - PURPOSE SECTION

Antacid

Keep Out of Reach of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep bottle tightly closed. Store in a cool, dry place, out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.

Uses

INDICATIONS & USAGE SECTION

Use for the prevention of calcium deficiency in adults.

Warnings

WARNINGS SECTION

Do not use more than directed.

As with any supplement, if you are pregnant or nursing a baby, contact your healthcare professional before use.

The seal of the package bears our name, Roxane. If the seal is broken or our name does not appear, do not use.

Directions

DOSAGE & ADMINISTRATION SECTION

Shake well before using. Take 5 mL (one teaspoonful) two to three times daily with meals or as directed by a physician.

Storage and Handling

STORAGE AND HANDLING SECTION

Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Keep from freezing.

Sodium content: 0 mg per 5 mL

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Methylparaben, propylene glycol, propylparaben, purified water, sodium hypochlorite solution, sorbitol solution, spearmint flavor, xanthan gum.

Questions or Comments

OTC - QUESTIONS SECTION

Repackaged and Distributed By:

Remedy Repack, Inc.

625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DRUG: Calcium Carbonate

GENERIC: Calcium Carbonate

DOSAGE: SUSPENSION

ADMINSTRATION: ORAL

NDC: 70518-3245-0

NDC: 70518-3245-1

PACKAGING: 5 mL in 1 CUP, UNIT DOSE

OUTER PACKAGING: 10 in 1 BOX

ACTIVE INGREDIENT(S):

  • CALCIUM CARBONATE 1250mg in 5mL

INACTIVE INGREDIENT(S):

  • SORBITOL
  • 1-PROPOXY-2-PROPANOL
  • XANTHAN GUM
  • METHYLPARABEN
  • SPEARMINT
  • SODIUM HYPOCHLORITE

Remedy_LabelRemedy_Label

MM2MM2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70518-3245-02023-10-16C16284748780-1f386c64a-197c-0266-e053-dadaa90a7c1aSupplement Facts
70518-3245-02023-01-30C16284748780-1f386c64a-197c-0266-e053-dadaa90a7c1aSupplement Facts

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0054-3117-63ML - Milliliter0054-3117f14bde6f-7bfd-4ee5-aa1c-01f1710253f712013-02-13

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70518-324570518-3245-1, 70518-3245-0
0054-3117

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
SORBITOL506T60A25RIACT
1-PROPOXY-2-PROPANOL152BY1743WIACT
XANTHAN GUMTTV12P4NEEIACT
METHYLPARABENA2I8C7HI9TIACT
SPEARMINTJ7I2T6IV1NIACT
SODIUM HYPOCHLORITEDY38VHM5ODIACT
CALCIUM CARBONATEH0G9379FGKACTIB

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
fb4771cd-f474-e2bd-e053-6394a90aa83eba26fc95-c10c-4c35-93a6-aea6f93a2db22023-05-09WarningsExact identifier
spl set id: ba26fc95-c10c-4c35-93a6-aea6f93a2db2

Reported adverse events (FAERS/openFDA)#

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