Label: ASSORTED FRUIT PANNED- 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 February 16, 2016

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  • ACTIVE INGREDIENT

    Calcium Carbonate 750mg

  • PURPOSE

    Purpose

    Antacid

  • INDICATIONS & USAGE

    Uses for the relief of:

    • acid indigestion
    • heartburn
    • sour stomach
    • upset stomach associated with these symptoms
  • WARNINGS

    Warnings

    Do not use if you have ever had an allergic reaction to this product or any of its ingredients

  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if you are presently taking a prescription drug. Antacids may interact with certian prescription drugs.

  • WHEN USING

    When using this product

    • do not take more than 5 chewable tablets in a 24-hour period
    • do not use the maximum dosage of this product for more htan 2 weeks except under the advice and supervision of a physician.
    • constipation may occur
  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • DOSAGE & ADMINISTRATION

    Directions

    • adults and children 12 years and over: chew and swallow 1-2 chewable tablets every 2-4 hours as symptoms occur, or as directed by a doctor
    • children under 12 years: consult a doctor
    • do not take more than 5 chewable tablets in a 24-hour period

  • OTHER SAFETY INFORMATION

    Other Information

    • each chewable tablet contains: calcium 300 mg
    • store at room temperature. Avoid excessive heat above 40C (104F).
  • INACTIVE INGREDIENT

    Inactive Ingredients

    acacia, carmine, carnauba wax, citric acid, corn starch, corn syrup, FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, FD&C yellow #6, flavors, hydrogenated coconut oil, lecithin, medium chain triglycerides, methly paraben, modified starch, phosporic acid, pregelatinized modified starch, propylene glycol, propyl paraben, purified water, shellac, sodium benozate, sorbic acid, sorbitol, sucrose, titanium dioxide, begetable oil, white wax

  • PRINCIPAL DISPLAY PANEL

    fruit

  • INGREDIENTS AND APPEARANCE
    ASSORTED FRUIT PANNED 
    calcium carbonate tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52642-229
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CARBONATE750 mg
    Inactive Ingredients
    Ingredient NameStrength
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    Product Characteristics
    Colororange, pink, yellowScorescore with uneven pieces
    ShapeROUNDSize70mm
    FlavorORANGE, STRAWBERRY, LEMONImprint Code AS
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52642-229-066 in 1 BOTTLE; Type 0: Not a Combination Product10/01/2014
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33110/01/2014
    Labeler - BestCo Inc (002149136)
    Registrant - Bayer (112117283)
    Establishment
    NameAddressID/FEIBusiness Operations
    BestCo Inc.002149136manufacture(52642-229)
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