Search by Drug Name or NDC

NDC 17089-0473-18 GUNA OSTEO 3; 8; 8; 6; 3; 4; 8; 4; 6; 6; 6 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL Details

GUNA OSTEO 3; 8; 8; 6; 3; 4; 8; 4; 6; 6; 6 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL

GUNA OSTEO is a ORAL SOLUTION/ DROPS in the HUMAN OTC DRUG category. It is labeled and distributed by Guna spa. The primary component is ARNICA MONTANA ROOT; CALCIUM FLUORIDE; CALCIUM PHOSPHATE; COMFREY ROOT; EQUISETUM HYEMALE; FUMARIC ACID; SILICON DIOXIDE; SUCCINIC ACID; SUS SCROFA OVARY; SUS SCROFA PLACENTA; SUS SCROFA UMBILICAL CORD.

Product Information

NDC	17089-0473
Product ID	17089-473_ba446257-56b6-616f-e053-2a95a90a1f16
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	GUNA OSTEO
Proprietary Name Suffix	n/a
Non-Proprietary Name	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 -
Product Type	HUMAN OTC DRUG
Dosage Form	SOLUTION/ DROPS
Route	ORAL
Active Ingredient Strength	3; 8; 8; 6; 3; 4; 8; 4; 6; 6; 6
Active Ingredient Units	[hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL
Substance Name	ARNICA MONTANA ROOT; CALCIUM FLUORIDE; CALCIUM PHOSPHATE; COMFREY ROOT; EQUISETUM HYEMALE; FUMARIC ACID; SILICON DIOXIDE; SUCCINIC ACID; SUS SCROFA OVARY; SUS SCROFA PLACENTA; SUS SCROFA UMBILICAL CORD
Labeler Name	Guna spa
Pharmaceutical Class	Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE]
DEA Schedule	n/a
Marketing Category	UNAPPROVED HOMEOPATHIC
Application Number	n/a
Listing Certified Through	2024-12-31

Package

Package Images

NDC 17089-0473-18 (17089047318)

Pricing Information	N/A
NDC Package Code	17089-473-18
Billing NDC	17089047318
Package	1 BOTTLE, DROPPER in 1 BOX (17089-473-18) / 30 mL in 1 BOTTLE, DROPPER
Marketing Start Date	2021-02-17
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL ba4462d6-9751-530f-e053-2995a90a1f16 Details

SPL UNCLASSIFIED SECTION

Take 15 minutes before meals

SPL UNCLASSIFIED SECTION

Inactive ingredient: Ethyl alcohol 30%.

QUESTIONS

Questions?: [email protected] (484) 223-3500

DIRECTIONS

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

Keep out of reach of children

PREGNANCY

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

WARNINGS

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

Temporarily relieves osteoporosis symptoms, such as:

minor bone pain.
fragile bones.

ACTIVE INGREDIENTS/PURPOSE

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

INGREDIENTS AND APPEARANCE

GUNA 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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:17089-473
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ARNICA MONTANA ROOT (UNII: MUE8Y11327) (ARNICA MONTANA ROOT - UNII:MUE8Y11327)	ARNICA MONTANA ROOT	3 [hp_X] in 30 mL
FUMARIC ACID (UNII: 88XHZ13131) (FUMARIC ACID - UNII:88XHZ13131)	FUMARIC ACID	4 [hp_X] in 30 mL
SUS SCROFA UMBILICAL CORD (UNII: 118OYG6W3H) (SUS SCROFA UMBILICAL CORD - UNII:118OYG6W3H)	SUS SCROFA UMBILICAL CORD	6 [hp_X] in 30 mL
SUS SCROFA OVARY (UNII: S7YTV04R8O) (SUS SCROFA OVARY - UNII:S7YTV04R8O)	SUS SCROFA OVARY	6 [hp_X] in 30 mL
SUS SCROFA PLACENTA (UNII: C8CV8867O8) (SUS SCROFA PLACENTA - UNII:C8CV8867O8)	SUS SCROFA PLACENTA	6 [hp_X] in 30 mL
COMFREY ROOT (UNII: M9VVZ08EKQ) (COMFREY ROOT - UNII:M9VVZ08EKQ)	COMFREY ROOT	6 [hp_X] in 30 mL
SUCCINIC ACID (UNII: AB6MNQ6J6L) (SUCCINIC ACID - UNII:AB6MNQ6J6L)	SUCCINIC ACID	4 [hp_X] in 30 mL
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4)	SILICON DIOXIDE	8 [hp_X] in 30 mL
CALCIUM FLUORIDE (UNII: O3B55K4YKI) (FLUORIDE ION - UNII:Q80VPU408O)	CALCIUM FLUORIDE	8 [hp_X] in 30 mL
CALCIUM PHOSPHATE (UNII: 97Z1WI3NDX) (CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM PHOSPHATE	8 [hp_X] in 30 mL
EQUISETUM HYEMALE (UNII: 59677RXH25) (EQUISETUM HYEMALE - UNII:59677RXH25)	EQUISETUM HYEMALE	3 [hp_X] in 30 mL

Ingredient Name	Strength
Inactive Ingredients
ALCOHOL (UNII: 3K9958V90M)	9 mL in 30 mL

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:17089-473-18	1 in 1 BOX	02/17/2021
1		30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		02/17/2021

Labeler - Guna spa (430538264)

Name	Address	ID/FEI	Business Operations
Establishment
Guna spa		338587646	manufacture(17089-473)

Revised: 2/2021

Document Id: ba446257-56b6-616f-e053-2a95a90a1f16

Set id: ba4462d6-9751-530f-e053-2995a90a1f16

Version: 1

Effective Time: 20210217

Search by Drug Name or NDC

NDC 17089-0473-18 GUNA OSTEO 3; 8; 8; 6; 3; 4; 8; 4; 6; 6; 6 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL Details

GUNA OSTEO 3; 8; 8; 6; 3; 4; 8; 4; 6; 6; 6 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL

Product Information

Package

Package Images

NDC 17089-0473-18 (17089047318)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL ba4462d6-9751-530f-e053-2995a90a1f16 Details

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

QUESTIONS

DIRECTIONS

WARNINGS

PREGNANCY

WARNINGS

USES

ACTIVE INGREDIENTS/PURPOSE

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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