Osteobios Solution/ Drops
FDA Label NDC 17089-259

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Guna Spa for the product Osteobios (NDC 17089-259). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients/purpose, uses, warnings, pregnancy, directions, questions, principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

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

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

Warnings

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

Keep this and all medicines out of reach of children

Pregnancy

If pregnant or breast-feeding ask a doctor before use

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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