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

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

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 03/10

If you are a consumer or patient please visit this version.

  • 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
    L-ISOLEUCINE        3X    IMPROVES BONE REPAIR
    L-LEUCINE        3X    IMPROVES BONE REPAIR
    L-LYSINE        3X    IMPROVES BONE REPAIR
    L-METHIONINE        3X    IMPROVES BONE REPAIR
    L-PHENYLALANINE        3X    IMPROVES BONE REPAIR
    L-THREONINE        3X    IMPROVES BONE REPAIR
    L-TRYPTOPHAN        3X    IMPROVES BONE REPAIR
    L-VALINE        3X    IMPROVES BONE REPAIR
    PARATHYROID GLAND    10X 30X 200X    IMPROVES BONE REPAIR

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  • USES

    For the temporary relief of symptoms related to acute and chronic fractures and impaired bone metabolism such as: sharp and dull bone pain, slow healing fractures

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  • WARNINGS

    Stop use and ask doctor if symptoms of sharp and dull bone pain worsen or persist more than 5 days

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  • PREGNANCY

    If pregnant or breast-feeding ask a doctor before use

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  • WARNINGS

    Keep this and all medicines out of reach of children

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  • DIRECTIONS

    Take 15 minutes before meals
    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

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  • QUESTIONS

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

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  • PRINCIPAL DISPLAY PANEL
  • 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 Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:17089-259
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CALCITONIN HUMAN (CALCITONIN HUMAN) CALCITONIN HUMAN 6 [hp_X]  in 30 mL
    ISOLEUCINE (ISOLEUCINE) ISOLEUCINE 3 [hp_X]  in 30 mL
    LEUCINE (LEUCINE) LEUCINE 3 [hp_X]  in 30 mL
    LYSINE (LYSINE) LYSINE 3 [hp_X]  in 30 mL
    METHIONINE (METHIONINE) METHIONINE 3 [hp_X]  in 30 mL
    PHENYLALANINE (PHENYLALANINE) PHENYLALANINE 3 [hp_X]  in 30 mL
    THREONINE (THREONINE) THREONINE 3 [hp_X]  in 30 mL
    TRYPTOPHAN (TRYPTOPHAN) TRYPTOPHAN 3 [hp_X]  in 30 mL
    VALINE (VALINE) VALINE 3 [hp_X]  in 30 mL
    CALCIUM CARBONATE (CALCIUM CATION and CARBONATE ION) CALCIUM CARBONATE 30 [hp_X]  in 30 mL
    CALCIUM FLUORIDE (CALCIUM FLUORIDE) CALCIUM FLUORIDE 30 [hp_X]  in 30 mL
    CALCIUM PHOSPHATE (CALCIUM CATION and PHOSPHATE ION) CALCIUM PHOSPHATE 30 [hp_X]  in 30 mL
    SUS SCROFA BONE (SUS SCROFA BONE) SUS SCROFA BONE 30 [hp_X]  in 30 mL
    SUS SCROFA PARATHYROID GLAND (SUS SCROFA PARATHYROID GLAND) SUS SCROFA PARATHYROID GLAND 30 [hp_X]  in 30 mL
    Inactive Ingredients
    Ingredient Name Strength
    ALCOHOL 9 mL  in 30 mL
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:17089-259-18 1 in 1 BOX
    1 30 mL in 1 BOTTLE, DROPPER
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved homeopathic 05/23/2006
    Labeler - Guna spa (430538264)
    Establishment
    Name Address ID/FEI Business Operations
    Guna spa 430538264 manufacture
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