Label: OSTEODORON AM SPECIAL FORMULA powder

  • 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 April 27, 2018

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  • INDICATIONS & USAGE

    Directions: FOR ORAL USE ONLY.

  • DOSAGE & ADMINISTRATION

    Take in the morning. Use in combination with Osteodoron PM Special Formula Powder. Ages 12 and older: 1/8 teaspoon. Ages 2-11: 1/16 teaspoon. Under age 2: Consult a doctor.

  • ACTIVE INGREDIENT

    Active Ingredients: Cucurbita (Squash) 3X, Apatite (Nat. calcium fluorophosphate) 6X, Fluorite (Calcium fluoride) 6X, Quartz (Rock crystal) 6X, Cerussite (White lead ore) 8X

  • INACTIVE INGREDIENT

    Inactive Ingredient: Lactose

  • PURPOSE

    Use: For healthy teeth and bone development.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN.

  • WARNINGS

    Warnings: Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated. Do not use if allergic to any ingredient. Contains lactose. Consult a doctor before use for serious conditions or if conditions worsen or persist. If pregnant or nursing, consult a doctor before use. Do not use if safety seal is broken or missing.

  • QUESTIONS

    Questions? Call 866.642.2858 Uriel, East Troy, WI 53120 www.urielpharmacy.com

  • PRINCIPAL DISPLAY PANEL

    OsteodoronAMSpecialFormulaPowder

  • INGREDIENTS AND APPEARANCE
    OSTEODORON AM SPECIAL FORMULA 
    osteodoron am special formula powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:48951-7115
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CUCURBITA PEPO FLOWER (UNII: 413MGP37HQ) (CUCURBITA PEPO FLOWER - UNII:413MGP37HQ) CUCURBITA PEPO FLOWER3 [hp_X]  in 1 g
    FLUORAPATITE (UNII: M4CM1H238J) (FLUORAPATITE - UNII:M4CM1H238J) FLUORAPATITE6 [hp_X]  in 1 g
    CALCIUM FLUORIDE (UNII: O3B55K4YKI) (FLUORIDE ION - UNII:Q80VPU408O) CALCIUM FLUORIDE6 [hp_X]  in 1 g
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE6 [hp_X]  in 1 g
    LEAD CARBONATE (UNII: 43M0P24L2B) (LEAD - UNII:2P299V784P) LEAD CARBONATE8 [hp_X]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE (UNII: J2B2A4N98G)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:48951-7115-460 g in 1 BOTTLE, GLASS; Type 0: Not a Combination Product09/01/2009
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic09/01/2009
    Labeler - Uriel Pharmacy Inc. (043471163)
    Establishment
    NameAddressID/FEIBusiness Operations
    Uriel Pharmacy Inc.043471163manufacture(48951-7115)
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