Label: MINT FLAVORED ANTACID 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 July 2, 2021

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  • Active Ingredient (in each tablet) Purpose

    Calcium Carbonate 420 mg................................................................................................................................antacid

  • Uses:

    for the relief of: ■ heartburn ■ sour stomach ■ acid indigestion

  • Warnings:

    Do not: ■ Take more than 18 tablets in a 24 hour period, or use the maximum dosage of this product for more than 2 weeks, except under the advice of a physician

  • Stop use and ask a doctor if:

    ■ You are currently taking any prescription drug. Antacids may react with certain prescription drugs.

  • If pregnant or breast-feeding baby

    ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN.

    In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • Directions:

    Adults and children 12 years of age and older: Take 2 tablets every 4 to 6 hours or as needed, do not exceed 18 tablets in 24 hours, or as directed by a doctor Children under 12 years: Consult a doctor.

  • Other Information:

    ■ Tamper Evident. Do not use if packet is torn, cut or opened ■ Store at controlled room temperature 15˚ to 30˚C (59˚ to 86˚F) ■ Avoid excessive heat and humidity ■ Each tablet contains: 168mg of elemental calcium

  • Inactive Ingredients:

    acacia gum, corn starch, flavor, invert sugar, magnesium stearate, silicon dioxide, starch and sucrose.

  • PRINCIPAL DISPLAY PANEL

    Antacid Box

  • INGREDIENTS AND APPEARANCE
    MINT FLAVORED ANTACID 
    mint flavored antacid tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71105-303
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CARBONATE420 mg
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SUCROSE (UNII: C151H8M554)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MINT (UNII: FV98Z8GITP)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize12mm
    FlavorMINTImprint Code fr8
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71105-303-68100 in 1 CARTON; Type 0: Not a Combination Product10/01/2017
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33102/01/2017
    Labeler - Redicare LLC (800149346)
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