Label: CALCAREA FLUORICA tablet, chewable

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

Drug Label Information

Updated February 28, 2014

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  • Active ingredients HPUS*

    Calcarea fluorica (Calcium fluoride) 6X

  • 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:60512-8010
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM FLUORIDE (UNII: O3B55K4YKI) (FLUORIDE ION - UNII:Q80VPU408O) CALCIUM FLUORIDE6 [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:60512-8010-5125 in 1 JAR
    2NDC:60512-8010-6500 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(60512-8010)
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