FDA.reportPublic FDA data

GUNA OSTEO

Manufacturer
Guna spa
Effective date
2021-02-17
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:14:23

Label at a glance#

ProductGUNA OSTEO
Active ingredientARNICA MONTANA ROOT, FUMARIC ACID, SUS SCROFA UMBILICAL CORD, SUS SCROFA OVARY, SUS SCROFA PLACENTA, COMFREY ROOT, SUCCINIC ACID, SILICON DIOXIDE, CALCIUM FLUORIDE, CALCIUM PHOSPHATE, EQUISETUM HYEMALE
Label structure10 sections

Indications and uses

Temporarily relieves osteoporosis symptoms, such as: minor bone pain. fragile bones.

Dosage and administration

Adults and children 12 years and older 20 drops in a little water, 2 times per day Children under 12 years of age consult a physician

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

Take 15 minutes before meals

INACTIVE INGREDIENT SECTION

Inactive ingredient: Ethyl alcohol 30%.

QUESTIONS

OTC - QUESTIONS SECTION

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

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

Adults and children 12 years and older 20 drops in a little water, 2 times per day



Children under 12 years of age consult a physician



WARNINGS

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

PREGNANCY

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

WARNINGS

WARNINGS SECTION

Stop use and ask doctor if symptoms persist more than 5 days.

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

Keep out of reach of children. In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.

Contains ethyl alcohol 30%

USES

OTC - PURPOSE SECTION

Temporarily relieves osteoporosis symptoms, such as:

  • minor bone pain.
  • fragile bones.

ACTIVE INGREDIENTS/PURPOSE

OTC - ACTIVE INGREDIENT SECTION

Arnica montana 3X Relieves pain

Calcarea fluorica 8X, 10X, 30X, 200X Supports bone metabolism and repair

Calcarea phosphorica 8X, 10X, 30X, 200X Supports bone metabolism and repair

Equisetum hyemale 3X Relieves pain

Fumaricum acidum 4X Relieves bone pain, supports bone repair

Funiculus umbilicalis suis 6X Supports bone metabolism

Oophorinum 6X Supports bone metabolism

Placenta totalis suis 6X Supports bone metabolism

Symphytum officinale 6X Relieves bone pain, supports bone repair

Succinicum acidum 4X Supports bone metabolism

Silicea 8X Relieves bone pain, supports bone repair

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

5USOSP-GUNA OSTEO5USOSP-GUNA OSTEO

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
Data codeData Matrix5USOSP5USOSP-GUNA OSTEO.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bee4fa8d-8d82-423a-a0b5-40a89dd13a99Product name120250618
e0d2eb29-08bd-4bba-90d1-c91c68a38767Product name420250516
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
334fe8d2-68fb-4331-a576-420e302ec069Product name720240320
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
e92765c1-be81-432a-b909-1b10777ec378Product name120190208
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
0441a8f5-3835-497c-aedd-bc78cba56b2aProduct name120150317
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17089-473-18GUNA OSTEO1 in 1 BOXSOLUTION/ DROPS11
17089-473-18GUNA OSTEO30 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17089-473GUNA OSTEO (ARNICA MONTANA ROOT - CALCIUM FLUORIDE - CALCIUM PHOSPHATE - EQUISETUM HYEMALE - FUMARIC ACID - SUS SCROFA UMBILICAL CORD - SUS SCROFA OVARY - SUS SCROFA PLACENTA - COMFREY ROOT - SUCCINIC ACID - SILICON DIOXIDE -) SOLUTION/ DROPS [GUNA SPA]1Current NDC, Legacy NDC, 2 package rows20210217_ba4462d6-9751-530f-e053-2995a90a1f16.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
17089-47317089-473-18

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MIACT
ARNICA MONTANA ROOTMUE8Y11327ACTIB
FUMARIC ACID88XHZ13131ACTIB
SUS SCROFA UMBILICAL CORD118OYG6W3HACTIB
SUS SCROFA OVARYS7YTV04R8OACTIB
SUS SCROFA PLACENTAC8CV8867O8ACTIB
COMFREY ROOTM9VVZ08EKQACTIB
SUCCINIC ACIDAB6MNQ6J6LACTIB
SILICON DIOXIDEETJ7Z6XBU4ACTIB
CALCIUM FLUORIDEO3B55K4YKIACTIB
CALCIUM PHOSPHATE97Z1WI3NDXACTIB
EQUISETUM HYEMALE59677RXH25ACTIB

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
GUNA OSTEOARNICA MONTANA ROOT - CALCIUM FLUORIDE - CALCIUM PHOSPHATE - EQUISETUM HYEMALE - FUMARIC ACID - SUS SCROFA UMBILICAL CORD - SUS SCROFA OVARY - SUS SCROFA PLACENTA - COMFREY ROOT - SUCCINIC ACID - SILICON DIOXIDE -Guna spaba4462d6-9751-530f-e053-2995a90a1f162021-02-17WarningsExact identifier
ndc (package): 17089-473-18
ndc (product): 17089-473
ndc11 (package): 17089047318
spl id: ba446257-56b6-616f-e053-2a95a90a1f16
spl set id: ba4462d6-9751-530f-e053-2995a90a1f16

Reported adverse events (FAERS/openFDA)#

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