CALCAREA FLUORICA (CALCIUM FLUORIDE) GRANULE [SEROYAL USA]

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CALCAREA FLUORICA (CALCIUM FLUORIDE) GRANULE [SEROYAL USA]
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NDC 62106-4948-4
Set ID 0da59c9b-ca13-0274-e054-00144ff88e88
Category HUMAN OTC DRUG LABEL
Packager Seroyal USA
Generic Name
Product Class
Product Number
Application Number
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  • ACTIVE INGREDIENT

    Active Ingredient

    CALCAREA FLUORICA (Calcium fluoride) 200K GR

    CALCAREA FLUORICA (Calcium fluoride) 30K GR

    CALCAREA FLUORICA (Calcium fluoride) 7CH GR

    CALCAREA FLUORICA (Calcium fluoride) 9CH GR

  • PURPOSE

    Indications

    Helps to support bone growth and healthy
    respiratory tract

  • WARNINGS

    Warning

    If pregnant or breastfeeding, ask a health professional 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 health professional 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.

  • INACTIVE INGREDIENT

    Inactive Ingredients

    Lactose,

    sucrose.

  • DOSAGE & ADMINISTRATION

    Directions

    Adults: Take five granules three times daily or as recommended by your healthcare practitioner.

    Children: Take three granules and follow adult directions.

  • QUESTIONS

    QUESTIONS? 1-888-737-6925.

  • INDICATIONS & USAGE

    Indications

    Helps to support bone growth and healthy
    respiratory tract

    Directions

    Adults: Take five granules three times daily or as recommended by your healthcare practitioner.

    Children: Take three granules and follow adult directions.

  • PRINCIPAL DISPLAY PANEL

    62106-4948

    UNDA

    Do not use if label perforation is broken

    Homeopathic Remedy

    NDC : 62106-4948-4

    CALCAREA FLUORICA

    Calcium fluoride

    140 granules

    Indications

    Helps to support bone growth and healthy
    respiratory tract

  • INGREDIENTS AND APPEARANCE
    CALCAREA FLUORICA 
    calcium fluoride granule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62106-4948
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM FLUORIDE (UNII: O3B55K4YKI) (FLUORIDE ION - UNII:Q80VPU408O) CALCIUM FLUORIDE3 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE (UNII: J2B2A4N98G)  
    SUCROSE (UNII: C151H8M554)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62106-4948-410 in 1 CARTON01/27/2015
    1140 in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic01/27/2015
    Labeler - Seroyal USA (018361118)
    Establishment
    NameAddressID/FEIBusiness Operations
    SAN’UP401010287manufacture(62106-4948)
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