Label: CALCIUM CARBONATE ORAL SUSPENSION- calcium carbonate suspension

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated April 10, 2020

If you are a consumer or patient please visit this version.

  • 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

    0904-7098-94 Lid

    Calcium Carbonate Oral Suspension

    0904-7098-94 IFU

    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.

    ___________________________________________________________________

    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

  • INGREDIENTS AND APPEARANCE
    CALCIUM CARBONATE ORAL SUSPENSION 
    calcium carbonate suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-7098
    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
    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
    ColorwhiteScore    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0904-7098-944 in 1 CASE11/10/2020
    110 in 1 TRAY
    15 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33111/10/2020
    Labeler - Major Pharmaceuticals (191427277)
    Registrant - Plastikon Healthcare (041717941)
    Establishment
    NameAddressID/FEIBusiness Operations
    Plastikon Healthcare, LLC041717941manufacture(0904-7098)