FDA.reportPublic FDA data

Osteoplex

Manufacturer
BioActive Nutritional, Inc. | Apotheca Company
Effective date
2018-05-09
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 00:58:41

Label at a glance#

ProductOsteoplex
Active ingredientEQUISETUM HYEMALE, MAGNESIUM CHLORIDE, ASCORBIC ACID, COMFREY ROOT, MANGANESE CHLORIDE, SUS SCROFA BONE MARROW, CALCIUM FLUORIDE, TRIBASIC CALCIUM PHOSPHATE, SILICON DIOXIDE, SUS SCROFA LIGAMENT, SUS SCROFA PARATHYROID GLAND
Label structure9 sections

Dosage and administration

10 drops orally, 3 times a day. Consult a physician for use in children under 12 years of age.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

Equisetum Hyemale 3X, Magnesia Muriatica 3X, Ascorbic Acid 6X, Manganum Muriaticum 6X, Symphytum Officinale 6X, Medulla Ossis Suis 8X, Calcarea Fluorica 12X, Calcarea Phosphorica 12X, Silicea 12X, Ligament (Suis) 8C, Parathyroid (Suis) 8C.

INDICATIONS:

OTC - PURPOSE SECTION

For temporary relief of pain in lower part of the back with burning, chronic lower back pain, soreness in the sacroiliac area, pain in the joints & bones.

WARNINGS:

WARNINGS SECTION

If pregnant or breast-feeding, ask a health care professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Do not use if tamper evident seal is broken or missing.

Store in cool, dry place.

KEEP OUT OF REACH OF CHILDREN:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

10 drops orally, 3 times a day. Consult a physician for use in children under 12 years of age.

INDICATIONS:

INDICATIONS & USAGE SECTION

For temporary relief of pain in lower part of the back with burning, chronic lower back pain, soreness in the sacroiliac area, pain in the joints & bones.

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Demineralized Water, 25% Ethanol.

QUESTIONS:

OTC - QUESTIONS SECTION

Distributed by:

BioActive Nutritional, Inc.

1803 N. Wickham Rd.

Melbourne, FL 32935

bioactivenutritional.com

PACKAGE LABEL DISPLAY:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BIOActive Nutritional

OSTEOPLEX

HOMEOPATHIC

1 FL OZ (30 ml)

OsteoplexOsteoplex

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43857-043043857-0430-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
EQUISETUM HYEMALE59677RXH25ACTIB
MAGNESIUM CHLORIDE02F3473H9OACTIM
ASCORBIC ACIDPQ6CK8PD0RACTIB
COMFREY ROOTM9VVZ08EKQACTIB
MANGANESE CHLORIDEQQE170PANOACTIM
SUS SCROFA BONE MARROWVP2CN2G7Y8ACTIB
CALCIUM FLUORIDEO3B55K4YKIACTIB
TRIBASIC CALCIUM PHOSPHATE91D9GV0Z28ACTIM
SILICON DIOXIDEETJ7Z6XBU4ACTIB
SUS SCROFA LIGAMENT2004Q810JOACTIB
SUS SCROFA PARATHYROID GLAND2KBE35NE8SACTIB
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
0456589d-2174-4dbb-b125-65c7ecf585404aaddaa3-b374-4ec2-9aeb-a8abdf6e31832018-05-09WarningsExact identifier
spl id: 0456589d-2174-4dbb-b125-65c7ecf58540
spl set id: 4aaddaa3-b374-4ec2-9aeb-a8abdf6e3183

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.