CALCIUM CARBONATE SUSPENSION [WEST-WARD PHARMACEUTICALS CORP.]

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CALCIUM CARBONATE SUSPENSION [WEST-WARD PHARMACEUTICALS CORP.]
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NDC 0054-3117-63
Set ID 594e80a9-b2fa-4a69-ab70-c25e78b1a40d
Category HUMAN OTC DRUG LABEL
Packager West-Ward Pharmaceuticals Corp.
Generic Name
Product Class
Product Number
Application Number PART331
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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 Product11/18/2004
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33111/18/2004
    Labeler - West-Ward Pharmaceuticals Corp. (080189610)
    Establishment
    NameAddressID/FEIBusiness Operations
    West-Ward Columbus Inc.058839929MANUFACTURE(0054-3117)
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