CALCAREA FLUORICA TABLET, CHEWABLE [HOMEOLAB USA INC]

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CALCAREA FLUORICA TABLET, CHEWABLE [HOMEOLAB USA INC]
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NDC 60512-8011-5, 60512-8011-6
Set ID 0a8c16c3-3919-4caf-8204-c3b82982cf99
Category HUMAN OTC DRUG LABEL
Packager HOMEOLAB USA INC
Generic Name
Product Class
Product Number
Application Number
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  • Active ingredients HPUS*

    Calcarea fluorica (Calcium fluoride) 12X

  • Purpose

    ...........................................Tissue elasticity, painful joints, dry chapped, cracked skin

  • REFERENCES

    The letters 'HPUS' indicate that the component in this product is officially monographed in the Homoeopathic Pharmacopoeia of the United States.

  • Uses

    This tissue salt helps improve tissue elasticity, painful joints and dry chapped or cracked skin.

    *These claims have not been reviewed by the Food and Drug Administration. They are based on traditional homeopathic practice.

  • Warnings


    Do not use if seal on snap-on lid is broken or missing.

    Stop use and ask a doctor if symptoms persist for more than 7 days or worsen.

    As with any drug, ask a doctor before use if pregnant or nursing.

    Keep this and all medications out of the reach of children.

    In case of emergency or accidental overdose, contact a medical professional or a Poison Control Center immediately.

  • Directions

    Children from 2 to 5 years: Crush 2 tablets and dissolve in water 3 times daily, or as directed by a healthcare professional.

    Adults and children over 5 years: Chew 2 tablets 3 times daily, or as directed by a healthcare professional.


    • Do not use more than directed.

    • Do not take with food.

  • Other information

    Store at room temperature.

  • Inactive ingredients

    Lactose, magnesium stearate.

  • LABEL

    image of label 125tabs

    image of label 500tabs

  • INGREDIENTS AND APPEARANCE
    CALCAREA FLUORICA 
    calcarea fluorica tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60512-8011
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM FLUORIDE (UNII: O3B55K4YKI) (FLUORIDE ION - UNII:Q80VPU408O) CALCIUM FLUORIDE12 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize8mm
    FlavorImprint Code NONE
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60512-8011-5125 in 1 JAR
    2NDC:60512-8011-6500 in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic02/28/2014
    Labeler - HOMEOLAB USA INC (202032533)
    Establishment
    NameAddressID/FEIBusiness Operations
    HOMEOLAB USA INC202032533manufacture(60512-8011)
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