Label: OSTEOBIOS- calcitonin human - calcium carbonate - calcium fluoride - calcium phosphate - isoleucine - leucine - lysine - methionine - phenylalanine - sus scrofa bone - sus scrofa parathyroid gland - threonine - tryptophan - valine - solution/ drops

  • 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 November 14, 2022

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  • ACTIVE INGREDIENTS/PURPOSE

    BONE 10X 30X 200X BONE FRACTURES

    CALCAREA FLUORICA 12X 30X 200X BONE FRACTURES

    CALCAREA CARBONICA 12X 30X 200X BONE FRACTURES

    CALCAREA PHOSPHORICA 12X 30X 200X BONE FRACTURES

    CALCITONIN 6X BONE FRACTURES

    PARATHYROID GLAND 10X 30X 200X IMPROVES BONE REPAIR


  • USES

    Temporary relief of symptoms related weak bones such as:

    • Frequent and slow-healing fractures
    • Sharp and dull bone pain
  • WARNINGS

    Stop use and ask doctor if symptoms persist more than 5 days.
    If pregnant or breast-feeding 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.
    Contains ethyl alcohol 30%

  • PREGNANCY

    If pregnant or breast-feeding ask a doctor before use

  • WARNINGS

    Keep out of reach of children

  • DIRECTIONS

    Adults and children 12 years and older 20 drops in a little water, 2 times per day

    Children between 12 years and 6 years of age 10 drops in a little water, 2 times per day

    Children under 6 years 5 drops in a glass of water, 2 times per day

  • QUESTIONS

    Questions?: info@gunainc.com, tel. (484) 223-3500

  • INACTIVE INGREDIENT

    Inactive ingredient: Ethyl alcohol 30%.

  • INDICATIONS & USAGE

    Take 15 minutes before meals

  • PRINCIPAL DISPLAY PANEL

    5USOST-REV05-03-04-18

  • INGREDIENTS AND APPEARANCE
    OSTEOBIOS 
    calcitonin human - calcium carbonate - calcium fluoride - calcium phosphate - isoleucine - leucine - lysine - methionine - phenylalanine - sus scrofa bone - sus scrofa parathyroid gland - threonine - tryptophan - valine - solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17089-259
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCITONIN HUMAN (UNII: I0IO929019) (CALCITONIN HUMAN - UNII:I0IO929019) CALCITONIN HUMAN6 [hp_X]  in 30 mL
    ISOLEUCINE (UNII: 04Y7590D77) (ISOLEUCINE - UNII:04Y7590D77) ISOLEUCINE3 [hp_X]  in 30 mL
    LEUCINE (UNII: GMW67QNF9C) (LEUCINE - UNII:GMW67QNF9C) LEUCINE3 [hp_X]  in 30 mL
    LYSINE (UNII: K3Z4F929H6) (LYSINE - UNII:K3Z4F929H6) LYSINE3 [hp_X]  in 30 mL
    METHIONINE (UNII: AE28F7PNPL) (METHIONINE - UNII:AE28F7PNPL) METHIONINE3 [hp_X]  in 30 mL
    PHENYLALANINE (UNII: 47E5O17Y3R) (PHENYLALANINE - UNII:47E5O17Y3R) PHENYLALANINE3 [hp_X]  in 30 mL
    THREONINE (UNII: 2ZD004190S) (THREONINE - UNII:2ZD004190S) THREONINE3 [hp_X]  in 30 mL
    TRYPTOPHAN (UNII: 8DUH1N11BX) (TRYPTOPHAN - UNII:8DUH1N11BX) TRYPTOPHAN3 [hp_X]  in 30 mL
    VALINE (UNII: HG18B9YRS7) (VALINE - UNII:HG18B9YRS7) VALINE3 [hp_X]  in 30 mL
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB, CARBONATE ION - UNII:7UJQ5OPE7D) CALCIUM CARBONATE30 [hp_X]  in 30 mL
    CALCIUM FLUORIDE (UNII: O3B55K4YKI) (FLUORIDE ION - UNII:Q80VPU408O) CALCIUM FLUORIDE30 [hp_X]  in 30 mL
    CALCIUM PHOSPHATE (UNII: 97Z1WI3NDX) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM PHOSPHATE30 [hp_X]  in 30 mL
    SUS SCROFA BONE (UNII: 597RLJ09RG) (SUS SCROFA BONE - UNII:597RLJ09RG) SUS SCROFA BONE30 [hp_X]  in 30 mL
    SUS SCROFA PARATHYROID GLAND (UNII: 2KBE35NE8S) (SUS SCROFA PARATHYROID GLAND - UNII:2KBE35NE8S) SUS SCROFA PARATHYROID GLAND30 [hp_X]  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M) 9 mL  in 30 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:17089-259-181 in 1 BOX05/01/2018
    130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic05/23/2006
    Labeler - Guna spa (430538264)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guna spa338587646manufacture(17089-259)
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