Label: CALCIUM CARBONATE suspension

  • NDC Code(s): 0054-3117-63
  • Packager: Hikma Pharmaceuticals USA Inc.
  • Category: HUMAN OTC DRUG LABEL

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 December 19, 2022

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  • CALCIUM CARBONATE Oral Suspension (not USP)

    Calcium Supplement

  • Supplement Facts

    Serving Size: 5 mL (teaspoonful)

    Amount Per Serving

    % Daily Value

    Calcium 500 mg

    50 %
  • Active Ingredient

    Each 5 mL (teaspoonful) delivers 1250 mg calcium carbonate (equivalent to 500 mg elemental calcium).

  • Purpose

    Antacid

  • Keep Out of Reach of Children

    Keep bottle tightly closed. Store in a cool, dry place, out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.

  • Uses

    Use for the prevention of calcium deficiency in adults.

  • Warnings

    Do not use more than directed.

    As with any supplement, if you are pregnant or nursing a baby, contact your healthcare professional before use.

    The seal of the package bears our name, Roxane. If the seal is broken or our name does not appear, do not use.

  • Directions

    Shake well before using. Take 5 mL (one teaspoonful) two to three times daily with meals or as directed by a physician.

  • Storage and Handling

    Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Keep from freezing.

    Sodium content: 0 mg per 5 mL

  • Inactive Ingredients

    Methylparaben, propylene glycol, propylparaben, purified water, sodium hypochlorite solution, sorbitol solution, spearmint flavor, xanthan gum.

  • Questions or Comments

    Call 1-800-962-8364. You may also report serious side effects to this phone number.

    Distr. by: West-Ward
    Pharmaceuticals Corp.
    Eatontown, NJ 07724

    4043502//04

    Revised November 2016

  • Package/Label Principal Display Panel

    CALCIUM CARBONATE Oral Suspension (not USP)

    0054-3117-63: 1250mg/5mL (provides 500mg elemental calcium per 5mL)

    label-4114101-09.jpg
  • INGREDIENTS AND APPEARANCE
    CALCIUM CARBONATE 
    calcium carbonate suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0054-3117
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CARBONATE1250 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    SORBITOL (UNII: 506T60A25R)  
    1-PROPOXY-2-PROPANOL (UNII: 152BY1743W)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    SPEARMINT (UNII: J7I2T6IV1N)  
    SODIUM HYPOCHLORITE (UNII: DY38VHM5OD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0054-3117-63500 mL in 1 BOTTLE; Type 0: Not a Combination Product11/18/200405/31/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33111/18/200405/31/2024
    Labeler - Hikma Pharmaceuticals USA Inc. (080189610)
    Establishment
    NameAddressID/FEIBusiness Operations
    West-Ward Columbus Inc.058839929MANUFACTURE(0054-3117)
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