CALCIUM CARBONATE ORAL SUSPENSION- calcium carbonate suspension

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]

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

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

Calcium Carbonate Oral Suspension

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

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

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

Calcium Carbonate Oral Solution

Active ingredient (in each 5 mL cup)

Calcium Carbonate 1250 mg

(Equivalent to 500 mg elemental Calcium)

Calcium Carbonate Oral Solution

Purpose

Antacid

Calcium Carbonate Oral Solution

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

Uses

relieves heartburn

relieves acid indigestion

relieves sour stomach

relieves upset stomach associated with these symptoms

INGREDIENTS AND APPEARANCE

CALCIUM CARBONATE ORAL SUSPENSION 
calcium carbonate suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0904-6842
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
GLYCERIN (UNII: PDC6A3C0OX)
SUCRALOSE (UNII: 96K6UQ3ZD4)
XANTHAN GUM (UNII: TTV12P4NEE)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
METHYLCELLULOSE, UNSPECIFIED (UNII: Z944H5SN0H)
SORBITOL (UNII: 506T60A25R)

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: 0904-6842-94	10 in 1 CASE	01/02/2020	03/02/2020
1		10 in 1 TRAY
1		5 mL in 1 CUP; 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	01/02/2020

Labeler - Major Pharmaceuticals (191427277)

Registrant - Plastikon Healthcare (041717941)

Establishment
Name	Address	ID/FEI	Business Operations
Plastikon Healthcare, LLC		041717941	manufacture(0904-6842)