Label: BELMORA MELOX AGRURA- 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 18, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient (in each tablet)

    Calcium Carbonate 420 mg

  • PURPOSE

    Purpose

    Antacid

  • INDICATIONS & USAGE

    Uses

    relieves

    ■ acid indigestion

    ■ sour stomach

    ■ heartburn

    ■ upset stomach associated with these symptoms

  • WARNINGS

    Warnings

  • DO NOT USE

    Do not use

    ■ the maximum dosage of this product for more than 2 weeks, except under the advice and supervision of a doctor

  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if you

    ■ are taking a prescription drug. Antacids may interact with certain prescription drugs.

    ■ have kidney disease

  • WHEN USING

    When using this product

    ■ do not take more than 19 tablets in a 24 hour period. If symptoms persist for more than two weeks, stop using this product and see a doctor.

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast feeding, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of the reach of children.

  • DOSAGE & ADMINISTRATION

    Directions

    Adults and children: (12 years and older) Chew 2 tablets every 2-3 hours or as symptoms occur, repeat hourly if needed.

    Do not exceed 19 tablets in 24 hours.

    Children under 12 years: ask a doctor

  • OTHER SAFETY INFORMATION

    Other information

    ■ calcium content per tablet: 168 mg

    ■ phenylketonurics: each tablet may contain1.5 mg phenylalanine

    ■ store at room temperature 59-86ºF (15-30ºC) in a dry place

    ■ tamper-evident sealed packets

    ■ do not use any opened or torn packets

  • INACTIVE INGREDIENT

    Inactive ingredients

    aspartame, croscarmellose sodium, magnesium stearate, maltodextrin, mineral oil, mint flavor, sorbitol

  • QUESTIONS

    Questions or comments?

    Call 1-800-779-2877 M-F 9AM-5PM EST

    Distributed by: Belmora LLC, 3033 Wilson Blvd. Suite 700, Arlington, VA 22201

    REV 02/2022

  • Belmora Melox

    NDC 27854-120-01

    Belmora LLC

    Melox

    Agrura/Heartburn

    Chew or Crush Tablets Completely Before Swallowing

    Masticar o Triturar Completamente Las Tabletas Antes De Tragar

    Antacid/Calcium Carbonate

    Antiacido/Carbonato De Calcio

    Heartburn, Indigestion

    Calcium Carbonate 420MG

    Las Aguras, La Indigestion

    Carbonato De Calco 420MG

    100 Tablets/50-Dual Packets/1 Tablets per Packet

    Tamper Evident Unit Dose Packets/Empacquetado con Sellado Evidente en Dosis Unitarias

    Belmora

  • INGREDIENTS AND APPEARANCE
    BELMORA MELOX AGRURA 
    calcium carbonate tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:27854-120
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB, CARBONATE ION - UNII:7UJQ5OPE7D) CALCIUM CARBONATE420 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    SORBITOL (UNII: 506T60A25R)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    ASPARTAME (UNII: Z0H242BBR1)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize11mm
    FlavorImprint Code AZ;036
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:27854-120-0150 in 1 CARTON06/03/2019
    12 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33106/03/2019
    Labeler - Belmora, LLC (112753244)
    Registrant - Unifirst First Aid Corporation (832947092)
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