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

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

Lid - 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

IFU Calcium Carbonate 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

CALCIUM CARBONATE ORAL SUSPENSION 
calcium carbonate suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-6842
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION1250 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
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
ColorwhiteScore    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0904-6842-9410 in 1 CASE01/02/202003/02/2020
110 in 1 TRAY
15 mL in 1 CUP; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33101/02/2020
Labeler - Major Pharmaceuticals (191427277)
Registrant - Plastikon Healthcare (041717941)
Establishment
NameAddressID/FEIBusiness Operations
Plastikon Healthcare, LLC041717941manufacture(0904-6842)

Revised: 2/2020
Document Id: 9e8d9152-e7db-2bdc-e053-2995a90a5668
Set id: 9b30c7d4-d36d-31ee-e053-2a95a90ac5ab
Version: 2
Effective Time: 20200214
 
Major Pharmaceuticals