Label: ANTACID FRUIT CHEW- 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 10, 2017

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  • ACTIVE INGREDIENT

    Active ingredient (in each chew)

    Calcium Carbonate 1000 mg

  • PURPOSE

    Purpose

    Antacid

  • INDICATIONS & USAGE

    Uses: Relieves

    Heartburn

    Sour stomach

    Acid indigestion

    Upset stomach due to 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 now taking a prescription drug. Antacids may interact with certain prescription drugs.

  • WHEN USING

    When using this product do not take more than 7 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.

    When using this product constipation may occur.

  • INACTIVE INGREDIENT

    If pregnant of 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 older chew and swallow 1 to 2 chews as symptoms occur. Do not exceed 7 chews in 24 hours.

    Children under 12 years consult a doctor.

  • OTHER SAFETY INFORMATION

    Each chew contains: calcium 400mg, magnesium 1mg, sodium 1mg

    Contains soy

    Contains FD&C yellow No. 5 (tartrazine) as a color additive

  • INACTIVE INGREDIENT

    Inactive ingredients: Beeswax, calcium carbonate, carnauba wax, coconut oil, corn syrup, ethyl acetate, FD&C blue no. 1 aluminum lake, FD&C red no. 40 aluminum lake, FD&C yellow no. 5 aluminum lake, FD&C yellow no. 6, FD&C yellow no. 6 aluminum lake, gum arabic, medium chain triclycerides, methyl paraben, modified corn starch, modified potato starch, natural and artificial flavors, palm oil, phosphoric acid, polyvinylpyrrolidone, potassium sorbate, propyl paraben, saccharose, shellac, sodium benzoate, sorbic acid, sorbitol, soy lecithin, sucrose, titanium dioxide, and water.

  • QUESTIONS

    Questions? Call 1-800-245-2898 Monday through Friday, 9AM - 4PM EST

  • PRINCIPAL DISPLAY PANEL

    CVS Ultra Antacid Fruit Chew 50ct

  • INGREDIENTS AND APPEARANCE
    ANTACID FRUIT CHEW 
    calcium carbonate tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-361
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CARBONATE1000 mg
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Colorgreen (Green, Orange, Red) Scoreno score
    ShapeROUNDSize14mm
    FlavorCHERRY (Cherry, Lime, Orange) Imprint Code FC
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69842-361-5050 in 1 BOTTLE; Type 0: Not a Combination Product01/31/2017
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33101/31/2017
    Labeler - CVS Pharmacy (062312574)
    Registrant - Bestco Inc. (002149136)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bestco Inc.002149136manufacture(69842-361)
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