FDA.reportPublic FDA data

Calcium Carbonate

Manufacturer
REMEDYREPACK INC.
Effective date
2022-03-25
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 22:04:58

Label at a glance#

ProductCalcium Carbonate
Active ingredientCALCIUM CARBONATE
Label structure11 sections

Indications and uses

Relieves: heartburn acid indigestion sour stomach upset stomach associated with these symptoms

Dosage and administration

Shake well before using. Take 1 to 2 teaspoonfuls (5 to 10 mL) as symptoms occur, or as directed by a doctor.

Storage and handling

store at 20° - 25°C (68° - 77°F) do not freeze Calcium Carbonate Oral Suspension is a pink-colored, bubble gum flavored suspension supplied in the following oral dosage forms: NDC 0121-0766-16: 16 fl oz (473 mL) bottle NDC 0121-4766-05: 5 mL unit dose cup, in a tray of ten cups.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each 5 mL teaspoonful)

OTC - ACTIVE INGREDIENT SECTION

Calcium Carbonate 1250 mg
(Equivalent to 500 mg elemental Calcium)

Purpose

OTC - PURPOSE SECTION

Antacid

Uses

INDICATIONS & USAGE SECTION

Relieves:

  • heartburn
  • acid indigestion
  • sour stomach
  • upset stomach associated with these symptoms

Warnings

WARNINGS SECTION

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are taking a prescription drug. Antacids may interact with certain prescription drugs.

OTC - WHEN USING SECTION

When using this product, do not take more than 6 teaspoonfuls (30 mL) in a 24-hour period or use the maximum dosage for more than 2 weeks.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Shake well before using.
  • Take 1 to 2 teaspoonfuls (5 to 10 mL) as symptoms occur, or as directed by a doctor.

Other information

STORAGE AND HANDLING SECTION

  • store at 20° - 25°C (68° - 77°F)
  • do not freeze
  • Calcium Carbonate Oral Suspension is a pink-colored, bubble gum flavored suspension supplied in the following oral dosage forms:
NDC 0121-0766-16:16 fl oz (473 mL) bottle
NDC 0121-4766-05:5 mL unit dose cup, in a tray of ten cups.

Inactive ingredients

INACTIVE INGREDIENT SECTION

calcium saccharin, citric acid, D&C Red No. 33, FD&C Red No. 40, flavoring, glycerin, methylparaben, propylene glycol, propylparaben, purified water, sorbitol and xanthan gum.

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-800-845-8210.

You may also report serious side effects to this phone number.

SPL UNCLASSIFIED 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: 70518-2265-0

NDC: 70518-2265-1

COLOR: pink

FLAVOR: BUBBLE GUM

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):

  • PROPYLPARABEN
  • METHYLPARABEN
  • PROPYLENE GLYCOL
  • SORBITOL
  • GLYCERIN
  • XANTHAN GUM
  • CITRIC ACID MONOHYDRATE
  • FD&C RED NO. 40
  • D&C RED NO. 33
  • SACCHARIN CALCIUM
  • WATER

Remedy_LabelRemedy_Label

MM2MM2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0121-0766-16ML - Milliliter0121-0766a19d6d49-7c07-4740-a670-1066e0d061f512014-11-05

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70518-226570518-2265-1, 70518-2265-0
0121-0766

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
PROPYLPARABENZ8IX2SC1OHIACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SORBITOL506T60A25RIACT
GLYCERINPDC6A3C0OXIACT
XANTHAN GUMTTV12P4NEEIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
FD&C RED NO. 40WZB9127XOAIACT
D&C RED NO. 339DBA0SBB0LIACT
SACCHARIN CALCIUM5101OP7P2IIACT
WATER059QF0KO0RIACT
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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Calcium CarbonateCALCIUM CARBONATEPAI Holdings, LLC dba PAI Pharmad89f3184-7081-4e16-a504-9214283891f62024-11-12WarningsExact identifier
ndc (product): 0121-0766
03876453-bb1d-5fc0-e063-6294a90adcfd645c1e53-aa8b-4a57-9184-77e5a2b9bd6c2023-08-22WarningsExact identifier
spl set id: 645c1e53-aa8b-4a57-9184-77e5a2b9bd6c

Reported adverse events (FAERS/openFDA)#

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