Osteotone

Manufacturer
Energique, Inc. | Apotheca Company
Effective date
2023-02-03
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 21:38:21

Label at a glance#

ProductOsteotone
Active ingredientCOMFREY ROOT, OYSTER SHELL CALCIUM CARBONATE, CRUDE, CALCIUM FLUORIDE, TRIBASIC CALCIUM PHOSPHATE, CAUSTICUM, HEKLA LAVA, PULSATILLA PRATENSIS WHOLE, TOXICODENDRON PUBESCENS LEAF, SILICON DIOXIDE, STRONTIUM CARBONATE
Label structure9 sections

Dosage and administration

Adults and children 5 to 10 drops orally, 3 times daily or as otherwise directed by a health care professional. If symptoms persist for more than 7 days, consult your health care professional. Consult a physician for use in children under 12 years of age.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

(in each drop): 10% of Calcarea Carbonica 12X, Calcarea Fluorica 12X, Calcarea Phosphorica 12X, Causticum 12X, Hekla Lava 12X, Pulsatilla (Pratensis) 12X, Rhus Tox 12X, Silicea 12X, Strontium Carbonicum 12X, Symphytum Officinale 3X.

INDICATIONS:

OTC - PURPOSE SECTION

May temporarily relieve pain in joints and bones and low back pain.**

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

WARNINGS:

WARNINGS SECTION

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

Adults and children 5 to 10 drops orally, 3 times daily or as otherwise directed by a health care professional. If symptoms persist for more than 7 days, consult your health care professional. Consult a physician for use in children under 12 years of age.

INDICATIONS:

INDICATIONS & USAGE SECTION

May temporarily relieve pain in joints and bones and low back pain.**

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Demineralized water, 20% Ethanol.

QUESTIONS:

OTC - QUESTIONS SECTION

Dist. by Energique, Inc.
201 Apple Blvd
Woodbine, IA 51579   800-869-8078

PACKAGE LABEL DISPLAY:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ENERGIQUE
SINCE 1987
HOMEOPATHIC REMEDY
OSTEOTONE
1 fl. oz. (30 ml)

OsteotoneOsteotone

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
44911-0447-12022-03-14C16284748780-1ba0f9c33-59f7-a910-e053-dadaa90a0b85Drug Facts:
44911-0447-12021-01-29C16284748780-1ba0f9c33-59f7-a910-e053-dadaa90a0b85Drug Facts:

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
44911-044744911-0447-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

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
40f6d914-5191-4ce5-a618-cbe7d81472f6e21fe062-21da-4c11-927f-2e11c5749cb12023-02-03WarningsExact identifier
spl id: 40f6d914-5191-4ce5-a618-cbe7d81472f6
spl set id: e21fe062-21da-4c11-927f-2e11c5749cb1

Reported adverse events (FAERS/openFDA)#

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