Label: CALCAREA FLUORICA 6X- calcium fluoride tablet

  • Category: HUMAN OTC DRUG LABEL

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 July 14, 2021

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • ACTIVE INGREDIENT

    Active Ingredients

    Calcarea fluorica (Calcium fluoride) 6X

  • PURPOSE

    Uses

    For the temporary relief of symptoms associated

    with cracking of joints and minor joint pain.

  • WARNINGS

    Warnings

    Do not use if you ever had an allergic reaction to this product or any of its ingredients.

    Stop use and ask a doctor if symptoms persist or worsen.

    If pregnant or breastfeeding, ask a healthcare practitioner before use.
    Keep out of reach of children.

    In case of overdose, get medical help or contact
    a Poison Control Center right away.

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breastfeeding, ask a healthcare practitioner before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • OVERDOSAGE

    In case of overdose, get medical help or contact

    a Poison Control Center right away.

  • ASK DOCTOR

    Stop use and ask a doctor if symptoms persist or worsen.

  • INACTIVE INGREDIENT

    Inactive Ingredients:

    Lactose monohydrate (milk),

    magnesium stearate,

    sodium carboxymethylcellulose,

    xylitol

  • DOSAGE & ADMINISTRATION

    Directions

    Tip bottle slightly allowing for tablets to fall into the cap.

    Use cap to drop tablets into mouth and allow them to dissolve under the tongue.

    Adults and adolescents (12 years and older)

    Take 1 to 4 tablets, one to four times daily, or as recommended by your healthcare practitioner.

    Children (under 12 years)

    Take under the direction of your healthcare practitioner.

  • INDICATIONS & USAGE

    Uses

    For the temporary relief of symptoms associated

    with cracking of joints and minor joint pain.

    Directions

    Tip bottle slightly allowing for tablets to fall into the cap.
    Use cap to drop tablets into mouth and allow them to dissolve under the tongue.
    Adults and Adolescents (12 years and older): Take 1 to 4 tablets, one to
    four times daily, or as recommended by your healthcare practitioner.

    Children (under 12 years): Take under the direction of your healthcare practitioner.

  • OTHER SAFETY INFORMATION

    Other information
    Do not use if seal is missing or broken.
    Store in a cool, dry place.

    Contents may not fill package in order
    to accommodate required labeling.
    Please rely on stated quantity.

  • PRINCIPAL DISPLAY PANEL

     62016-1050-2

    NDC 62016-1050-2

    UNDA

    tissue salt

    CALCAREA FLUORICA 6X

    Homeopathic Preparation

    Cell Salt

    For the temporary relief of symptoms associated

    with cracking of joints and minor joint pain.

    100 Tablets

  • INGREDIENTS AND APPEARANCE
    CALCAREA FLUORICA 6X 
    calcium fluoride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62106-1050
    Route of AdministrationSUBLINGUAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM FLUORIDE (UNII: O3B55K4YKI) (FLUORIDE ION - UNII:Q80VPU408O) CALCIUM FLUORIDE6 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    XYLITOL (UNII: VCQ006KQ1E)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize7mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62106-1050-21 in 1 BOX10/02/2015
    1100 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic02/10/2015
    Labeler - Seroyal USA (018361118)
    Establishment
    NameAddressID/FEIBusiness Operations
    SAN'UP401010287manufacture(62106-1050)