Label: PREMIER VALUE MAXIMUM STRENGTH ASSORTED FRUIT- calcium carbonate, simethicone tablet, chewable

  • NDC Code(s): 68016-249-00
  • Packager: PHARMACY VALUE ALLIANCE, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 3, 2023

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  • Active ingredients (in each tablet)

    Calcium carbonate 1000 mg

    Simethicone 60 mg

  • Purpose

    Antacid

    Antigas

  • Uses

    relieves:

    ▪
    acid indigestion
    ▪
    heartburn
    ▪
    sour stomach
    ▪
    upset stomach due to these symptoms
    ▪
    bloating and pressure commonly referred to as gas
  • Warnings

    Do not take more than 8 tablets in 24 hours or use the maximum dosage for more than 2 weeks except under the advice and supervision of a doctor.

    Ask a doctor before use if you have

    ▪
    kidney stones
    ▪
    a calcium-restricted diet

    Ask a doctor or pharmacist before use if you are

    presently taking a prescription drug. Antacids may interact with certain prescription drugs.

    When using this product

    at maximum dose, constipation may occur.

    Stop use and ask a doctor if

    symptoms persist for more than 2 weeks.

    Keep out of reach of children.

  • Directions

    ▪
    adults and children 12 years and older: chew 1 to 2 tablets completely as symptoms occur or as directed by a doctor. Do not swallow tablets whole.
    ▪
    do not take more than 8 tablets in 24 hours or use the maximum dosage for more than 2 weeks except under the advice and supervision of a doctor.
  • Other information

    ▪
    each tablet contains: calcium 400 mg
    ▪
    store at room temperature
    ▪
    keep tightly closed and dry
    ▪
    avoid freezing
    ▪
    do not use if printed inner seal is broken or missing
  • Inactive ingredients

    adipic acid, D&C Yellow No. 10, dextrose, FD&C Red No. 40, FD&C Yellow No. 6, flavors, magnesium stearate, maltodextrin, silica, starch, sucralose.

    Questions or comments?

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  • Package/Label Principal Display Panel

    Premier Value®

    *COMPARE TO THE ACTIVE INGREDIENTS IN MAALOX® ADVANCED MAXIMUM STRENGTH

    NDC: 68016-249-00

    Antacid & Anti-Gas

    MAXIMUM STRENGTH

    Fast relief of:

    ▪
    Heartburn
    ▪
    Acid indigestion
    ▪
    Pressure & bloating
     
    Assorted Fruit
     
    Naturally Artificially Flavored

    90 Chewable Tablets

    INDEPENDENTLY TESTED PV SATISFACTION GURANTEED

    Distributed by:

    Pharmacy Value Alliance, LLC

    407 East Lancaster Avenue,

    Wayne, PA 19087

    If for any reason you are not satisfied with this product, please return it to the store where purchased for a full refund.

    *This product is not manufactured or distributed by Novartis Consumer Health, Inc., the distributor of Maalox® Advanced Maximum Strength.

    Premier Value Maximum Strength Assorted Fruit 90 Chewable Tablets
  • INGREDIENTS AND APPEARANCE
    PREMIER VALUE MAXIMUM STRENGTH  ASSORTED FRUIT
    calcium carbonate, simethicone tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-249
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB, CARBONATE ION - UNII:7UJQ5OPE7D) CALCIUM CARBONATE1000 mg
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE60 mg
    Inactive Ingredients
    Ingredient NameStrength
    ADIPIC ACID (UNII: 76A0JE0FKJ)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    ColorORANGE, YELLOW, RED (PINKISH) Scoreno score
    ShapeROUNDSize17mm
    FlavorFRUIT (ASSORTED) Imprint Code RP104
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68016-249-0090 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/22/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00104/22/2019
    Labeler - PHARMACY VALUE ALLIANCE, LLC (101668460)
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