Calcium Carbonate Oral Suspension

Manufacturer
Major Pharmaceuticals | Plastikon Healthcare | Plastikon Healthcare, LLC
Effective date
2020-02-14
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 23:36:41

Label at a glance#

ProductCalcium Carbonate Oral Suspension
Active ingredientCALCIUM CARBONATE
Label structure1 sections

Label contents#

Full prescribing information#

Major Pharmaceuticals Calcium Carbonate Oral Suspension, USP 5 mL unit dose cup

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Lid - Calcium Carbonate 5 mLLid - Calcium Carbonate 5 mL

NDC 0904-6842-94

Calcium Carbonate

Oral Suspension, USP

1250 mg/5 mL

(equivalent to 500 mg of elemental Calcium)

Delivers 5 mL

Antacid - Shake Well

See Insert

For Institutional Use Only

Major Pharmaceuticals

Livonia, MI 48152

Sugar Free - Alcohol Free

Calcium Carbonate Oral Suspension IFU 5 mL

INSTRUCTIONS FOR USE SECTION

IFU Calcium Carbonate 5 mLIFU Calcium Carbonate 5 mL

Calcium Carbonate Oral Suspension

DOSAGE & ADMINISTRATION SECTION

Directions

- do not exceed the maximum recommended daily dose in a 24-hour period

- do not use the maximum dosage for more than 2 weeks

- shake well before use

Dose (mL)

5-10 mL as symptoms occur

Do not take more than 30 mL in 24 hours.

Calcium Carbonate Oral Solution

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Calcium Carbonate Oral Solution

WARNINGS SECTION

Warnings

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

___________________________________________________________________

If pregnant or breast-feeding, ask a health professional before use.

Calcium Carbonate Oral Solution

INACTIVE INGREDIENT SECTION

Inactive ingredients cherry flavor, citric acid, glycerin, methyl cellulose, methyl paraben, propyl paraben, purified water, sorbitol, sucralose, xanthan gum.

Calcium Carbonate Oral Solution

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each 5 mL cup)

Calcium Carbonate 1250 mg

(Equivalent to 500 mg elemental Calcium)

Calcium Carbonate Oral Solution

OTC - PURPOSE SECTION

Purpose

Antacid

Calcium Carbonate Oral Solution

OTHER SAFETY INFORMATION

Other information

- store at 20-25°C (68-77°F)

- protect from excessive moisture

- do not use if lid seal is open or damaged

- sugar free, dye free, alcohol free

- see bottom of cup for lot number and expiration date

Questions or comments?

Call 1-800-616-2471

Calcium Carbonate Oral Suspension

INDICATIONS & USAGE SECTION

Uses

relieves heartburn

relieves acid indigestion

relieves sour stomach

relieves upset stomach associated with these symptoms

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-6842-94ML - Milliliter0904-68423d400e1f-a365-452d-a57c-247b8e5df9c112020-03-10

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
0904-68420904-6842-94

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

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
1c8940f1-53ba-4f30-9cd2-0ec05f9416e99b30c7d4-d36d-31ee-e053-2a95a90ac5ab2024-11-15WarningsExact identifier
spl set id: 9b30c7d4-d36d-31ee-e053-2a95a90ac5ab

Reported adverse events (FAERS/openFDA)#

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