Label: MAJOR REGULAR STRENGTH ASSORTED FLAVORS- antacid tablets 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 22, 2021

If you are a consumer or patient please visit this version.

  • Active ingredient

    Calcium Carbonate USP 500mg

  • Purpose

    Antacid

  • Uses

    relieves:

    • heartburn

    • sour stomach

    • acid indigestion

    • upset stomach associated with these symptoms

  • Warnings

    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

    • do not take more than 15 tablets in 24 hours
    • If pregnant do not take more than 10 tablets in 24 hours
    • do not use the maximum dosage for more than 2 weeks except under the advice and supervision of a doctor.
  • Keep out of Reach of Children

  • Directions

    • Adults and children 12 years of age and over: chew 2-4 tablets as symptoms occur, or as directed by a doctor.
    • Do not swallow tablets whole,
    • Do not take for symptoms that persist for more than 2 weeks unless advised by a doctor.
  • Other Information

    • Each tablet contains: elemental calcium 200 mg
    • Store at room temperature. Keep the container tightly closed

    Safety sealed: Do not use if printed seal under cap is torn or missing.

  • Inactive ingredients

    adipic acid, D&C Red No. 27 lake, D&C Yellow No. 10 lake, dextrose, FD&C Blue No. 1 lake, FD&C Yellow No. 6 lake, flavors, magnesium stearate, maltodextrin, starch, sucralose.

  • PRINCIPAL DISPLAY PANEL

    DRUG: Major Regular StrengthAssorted Flavors Assorted Flavors

    GENERIC: Antacid Tablets

    DOSAGE: TABLET, CHEWABLE

    ADMINSTRATION: ORAL

    NDC: 70518-0415-0

    NDC: 70518-0415-1

    NDC: 70518-0415-2

    COLOR: white

    FLAVOR: FRUIT

    SHAPE: ROUND

    SCORE: No score

    SIZE: 16 mm

    IMPRINT: RP101

    PACKAGING: 30 in 1 BLISTER PACK

    PACKAGING: 30 in 1 BOX

    PACKAGING: 1 in 1 POUCH

    ACTIVE INGREDIENT(S):

    • CALCIUM CARBONATE 500mg in 1

    INACTIVE INGREDIENT(S):

    • ADIPIC ACID
    • D&C RED NO. 27
    • D&C YELLOW NO. 10
    • DEXTROSE, UNSPECIFIED FORM
    • FD&C BLUE NO. 1
    • FD&C YELLOW NO. 6
    • MAGNESIUM STEARATE
    • MALTODEXTRIN
    • STARCH, CORN
    • SUCRALOSE

    Remedy_Label

    MM2

    MM3

  • INGREDIENTS AND APPEARANCE
    MAJOR REGULAR STRENGTH  ASSORTED FLAVORS
    antacid tablets tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70518-0415(NDC:0904-6412)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CARBONATE500 mg
    Inactive Ingredients
    Ingredient NameStrength
    ADIPIC ACID (UNII: 76A0JE0FKJ)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize16mm
    FlavorFRUITImprint Code RP101
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70518-0415-030 in 1 BLISTER PACK; Type 0: Not a Combination Product04/10/2017
    2NDC:70518-0415-130 in 1 BOX04/15/201905/06/2019
    2NDC:70518-0415-21 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33104/10/2017
    Labeler - REMEDYREPACK INC. (829572556)