Label: ORANGE ANTACID SOFTCHEW- calcium carbonate tablet, chewable

  • 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 March 14, 2014

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  • ACTIVE INGREDIENT

    Active ingredient (in each chew)

    Calcium Carbonate 1177 mg

  • PURPOSE

    Purpose

    Antacid

  • INDICATIONS & USAGE

    Uses: relieves

    heartburn

    sour stomach

    acid indigestion

    upset stomach due to these symptoms

  • WARNINGS

    Warnings

    Ask a doctor or pharmacist before use if you are now taking a prescription drug. Antacids may interact with certain perscription drugs.

    Do not take more than 6 chews in a 34-hour period, or use the maximum dosage for more than 2 weeks, except under the advice and supervision of a physician.

  • PREGNANCY OR BREAST FEEDING

    If you ae pregnant or nursing a baby, ask a doctor before using this product.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • DOSAGE & ADMINISTRATION

    Directions

    Chew and swallow 2 to 3 chews, as symptoms occur or as directed by a physician.

  • OTHER SAFETY INFORMATION

    Other information

    Each chew contains: calcium 470 mg, mangesium 5mg

    Contains milk and soy

    Store between 20° to 25ºC (68º to 77ºF) in a dry place

  • INACTIVE INGREDIENT

    inactive ingredients: Corn syrup, corn syrup solids, FD&C yellow #6 aluminum lake, glycerin, hydrogenated coconut oil, natural and artificial flavors, non-fat dairy milk powder, soy lecithin, and sucrose. Soybean oil and corn starch used as processing aids.

  • QUESTIONS

    Questions? Or to report an adverse event call 1-800-245-2898, Monday - Friday, 8AM -4PM EST

  • PRINCIPAL DISPLAY PANEL

    BestHealth Orange Antacid 32ct

  • INGREDIENTS AND APPEARANCE
    ORANGE ANTACID SOFTCHEW 
    calcium carbonate tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52642-021
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CARBONATE1177 mg
    Inactive Ingredients
    Ingredient NameStrength
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    ColororangeScoreno score
    ShapeRECTANGLESize22mm
    FlavorORANGEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52642-021-3232 in 1 BAG; Type 0: Not a Combination Product03/14/2014
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33103/14/2014
    Labeler - BestCo Inc. (002149136)
    Registrant - BestCo Inc. (002149136)
    Establishment
    NameAddressID/FEIBusiness Operations
    BestCo Inc.002149136manufacture(52642-021)
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