Label: ASSORT 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: Relieves

    • Heartburn
    • Sour Stomach
    • Acid Indigestion
    • Upset stomach due to these symptoms
  • WARNINGS

    Warnings

    Do not take more than 5 chews in a 24-hour period, or use the maximum dosage for more than 2 weeks, except under the advice and supervision of a physician.

  • ASK DOCTOR/PHARMACIST

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

  • 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. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

  • DOSAGE & ADMINISTRATION

    Directions

    Adults and chldren 12 years and older chew and swallow 2 to 4 chews hourly if needed. Do not exceed 5 chews in 24 hours. Children under 12 years consult a doctor.

  • OTHER SAFETY INFORMATION

    Other information

    Each chew contains: calcium 300mg, mangnesium 1mg

    Contains: Soy

    Store between 20C to 25C (68 to 77F) in a dry place

  • INACTIVE INGREDIENT

    Inactive Ingredients:

    Beeswax, carmine, carnauba wax, citric acid, corn syrup, DL-alpha tocopherol, ethyl acetate, FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake, FD&C yellow #5 lake (tartrazine), FD&C yellow #6, FD&C yellow #6 aluminum lake, gum arabic, hydrogenated coconut oil, medium chain triglycerides, methly paraben, modified corn starch, natural and artificial flavors, pregelatinized corn starch, propylene glycol, propyl paraben, phosphoric acid, purified water, shellac, sodium benzoate, sorbic acid, sorbitol, soy lecithin, sucrose, titanium dioxide

    Soybean oil and corn starch used as processing aids.

  • QUESTIONS

    Questions?

    1-800-632-6900

  • PRINCIPAL DISPLAY PANEL

    Assort fruit

  • INGREDIENTS AND APPEARANCE
    ASSORT FRUIT PANNED 
    calcium carbonate tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:30142-030
    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
    Coloryellow, pink, orangeScorescore with uneven pieces
    ShapeROUNDSize70mm
    FlavorLEMON, ORANGE, STRAWBERRYImprint Code FC
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:30142-030-3636 in 1 BOTTLE; Type 0: Not a Combination Product07/18/2014
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33107/18/2014
    Labeler - Kroger (006999528)
    Registrant - BestCo (002149136)
    Establishment
    NameAddressID/FEIBusiness Operations
    BestCo Inc.002149136manufacture(30142-030)
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