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

Calcium Carbonate Oral Suspension by

Drug Labeling and Warnings

Calcium Carbonate Oral Suspension by is a Otc medication manufactured, distributed, or labeled by Major Pharmaceuticals, Plastikon Healthcare, Plastikon Healthcare, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

CALCIUM CARBONATE ORAL SUSPENSION- calcium carbonate suspension 
Major Pharmaceuticals

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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

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

NDC: 0904-7098-94

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

Calcium Carbonate

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

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

Warnings

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

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

Calcium Carbonate

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

Calcium Carbonate

Uses

- relieves heartburn

- relieves acid indigestion

- relieves sour stomach

- relieves upset stomach associated with these symptoms

Calcium Carbonate

Active ingredient (in each 5 mL cup)

Calcium Carbonate 1250 mg

(Equivalent to 500 mg elemental Calcium)

Calcium Carbonate

Purpose

Antacid

Calcium Carbonate

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 
calcium carbonate suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0904-7098
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM CATION	1250 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
SORBITOL (UNII: 506T60A25R)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
XANTHAN GUM (UNII: TTV12P4NEE)
METHYLPARABEN (UNII: A2I8C7HI9T)
SUCRALOSE (UNII: 96K6UQ3ZD4)
GLYCERIN (UNII: PDC6A3C0OX)
METHYLCELLULOSE, UNSPECIFIED (UNII: Z944H5SN0H)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	white	Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0904-7098-94	4 in 1 CASE	11/10/2020	04/29/2022
1		10 in 1 TRAY
1		5 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part331	11/10/2020	04/29/2022

Labeler - Major Pharmaceuticals (191427277)

Registrant - Plastikon Healthcare (041717941)

Establishment
Name	Address	ID/FEI	Business Operations
Plastikon Healthcare, LLC		041717941	manufacture(0904-7098)

Revised: 9/2022

Document Id: e95ebbe8-879e-db22-e053-2995a90aa2ab

34390-5

Set id: a2f5e91a-a9f5-8a80-e053-2995a90a29ff

Version: 3

Effective Time: 20220923