Label: MULTI SYMPTOM ANTACID BERRY FLAVOR- calcium carbonate ,magnesium hydroxide,simethicone 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 January 21, 2021

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients (in each tablet)

    Calcium Carbonate USP 675 mg
    Magnesium hydroxide USP 135 mg

    Simethicone USP 60mg

  • Purpose

    Antacid

    Antacid

    Antigas

  • Uses

    relieves:

    ▪
    heartburn
    ▪
    acid indigestion
    ▪
    pressure, bloating and discomfort commonly referred to as gas
  • Warnings

    Ask a doctor or pharmacist before use if you are 

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

    When using this product

    ▪
    Do not take more than 8 tablets in a 24-hour period
    ▪
    Do not use the maximum dosage for more than 2 weeks

    Keep out of reach of children.

  • Directions

    ▪
    chew 2-4 tablets completely as symptoms occur or as directed by a doctor.
  • Other information

    ▪
    each tablet contains: calcium 270 mg, magnesium 55 mg
    ▪
    store between 20-25C (68-77F).

    Avoid high humidity

  • Inactive ingredients

    corn starch, dextrose, D&C Red No. 27 lake, FD&C Blue No. 1 lake, flavor, magnesium stearate, maltodextrin, silicon dioxide, sucralose.

    Questions?

    1-866-467-2748

  • PRINCIPAL DISPLAY PANEL

    NDC# 63868-178-10

    Compare To Rolaids® Extra Strength active ingredients*

    Antacid Tablets

    Multi-Symptom

    Antacid & Anti-gas

    Rapid relief of:

    Heartburn

    Gas Pressure

    Bloating & Discomfort

    Acid Indigestion

    Berry Flavor

    100 CHEWABLE TABLETS

    100% QC SATISFACTION GURANTEED

    Distributed by C.D.M.A., Inc.©

    41357 W. Nine Mile

    Novi, MI 48376-0995

    www.qualitychoice.com

    Questions: 248-449-9300

    *This product is not manufactured or distributed by Chattem Inc., owner of the registered trademark ROLAIDS®

    TAMPER EVIDENT: DO NOT USE IF PRINTED INNER SEAL IS BROKEN OR MISSING.

    QC(CDMA) Multi-Symptom Antacid Tablets Berry Flavor
  • INGREDIENTS AND APPEARANCE
    MULTI SYMPTOM ANTACID  BERRY FLAVOR
    calcium carbonate ,magnesium hydroxide,simethicone tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-178
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CARBONATE675 mg
    MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM HYDROXIDE135 mg
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE60 mg
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    ColorWHITE (Pinkish) Scoreno score
    ShapeROUNDSize16mm
    FlavorBERRYImprint Code RP107
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63868-178-10100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/17/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33104/17/2019
    Labeler - QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION) (011920774)
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