Label: OSTEODORON PM powder
- NDC Code(s): 48951-7191-4
- Packager: Uriel Pharmacy Inc.
- 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 December 16, 2024
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- DOSAGE & ADMINISTRATION
- ACTIVE INGREDIENT
- INACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
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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.
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INGREDIENTS AND APPEARANCE
OSTEODORON PM
osteodoron pm powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:48951-7191 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OSTREA EDULIS SHELL (UNII: 49OY13BE7Z) (OSTREA EDULIS SHELL - UNII:49OY13BE7Z) OSTREA EDULIS SHELL 1 [hp_X] in 1 g SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE 6 [hp_X] in 1 g QUERCUS ROBUR WHOLE (UNII: R7QMG0BT2W) (QUERCUS ROBUR WHOLE - UNII:R7QMG0BT2W) QUERCUS ROBUR WHOLE 4 [hp_X] in 1 g CALCIUM FLUORIDE (UNII: O3B55K4YKI) (FLUORIDE ION - UNII:Q80VPU408O) CALCIUM FLUORIDE 6 [hp_X] in 1 g Inactive Ingredients Ingredient Name Strength LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:48951-7191-4 50 g in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 09/01/2009 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 09/01/2009 Labeler - Uriel Pharmacy Inc. (043471163) Establishment Name Address ID/FEI Business Operations Uriel Pharmacy Inc. 043471163 manufacture(48951-7191)