Search by Drug Name or NDC

NDC 17089-0464-18 GUNA FLAM RELIEF 6; 6; 3; 6; 4; 6; 6; 3; 4; 12; 2; 6; 6; 30; 3; 200 [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; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL Details

GUNA FLAM RELIEF 6; 6; 3; 6; 4; 6; 6; 3; 4; 12; 2; 6; 6; 30; 3; 200 [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; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL

GUNA FLAM RELIEF is a ORAL SOLUTION/ DROPS in the HUMAN OTC DRUG category. It is labeled and distributed by Guna spa. The primary component is ACONITUM NAPELLUS WHOLE; APIS MELLIFERA; ARNICA MONTANA; ATROPA BELLADONNA; BASIC CUPRIC CARBONATE; BRYONIA ALBA ROOT; CALCIUM SULFIDE; CITRIC ACID MONOHYDRATE; ECHINACEA ANGUSTIFOLIA WHOLE; FERRIC PHOSPHATE; MATRICARIA CHAMOMILLA WHOLE; PHYTOLACCA AMERIC.

Product Information

NDC	17089-0464
Product ID	17089-464_af5aec5c-a562-6516-e053-2a95a90a3be9
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 FLAM RELIEF
Proprietary Name Suffix	n/a
Non-Proprietary Name	ACONITUM NAPELLUS - APIS MELLIFERA - ARNICA MONTANA WHOLE - ATROPA BELLADONNA - BASIC CUPRIC CARBONATE - BRYONIA ALBA ROOT - MATRICARIA CHAMOMILLA WHOLE - CALCIUM SULFIDE - CITRIC ACID MONOHYDRATE - ECHINACEA ANGUSTIFOLIA - FERRIC PHOSPHATE - PHYTOLACCA A
Product Type	HUMAN OTC DRUG
Dosage Form	SOLUTION/ DROPS
Route	ORAL
Active Ingredient Strength	6; 6; 3; 6; 4; 6; 6; 3; 4; 12; 2; 6; 6; 30; 3; 200
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; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL
Substance Name	ACONITUM NAPELLUS WHOLE; APIS MELLIFERA; ARNICA MONTANA; ATROPA BELLADONNA; BASIC CUPRIC CARBONATE; BRYONIA ALBA ROOT; CALCIUM SULFIDE; CITRIC ACID MONOHYDRATE; ECHINACEA ANGUSTIFOLIA WHOLE; FERRIC PHOSPHATE; MATRICARIA CHAMOMILLA WHOLE; PHYTOLACCA AMERIC
Labeler Name	Guna spa
Pharmaceutical Class	Acidifying Activity [MoA], Allergens [CS], Anti-coagulant [EPC], Bee Venoms [CS], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Cell-mediated Immunity [PE], Decreased Coagulation Factor Activity [PE], Increased Histamine Release [PE],
DEA Schedule	n/a
Marketing Category	UNAPPROVED HOMEOPATHIC
Application Number	n/a
Listing Certified Through	2024-12-31

Package

Package Images

NDC 17089-0464-18 (17089046418)

Pricing Information	N/A
NDC Package Code	17089-464-18
Billing NDC	17089046418
Package	1 BOTTLE, DROPPER in 1 BOX (17089-464-18) / 30 mL in 1 BOTTLE, DROPPER
Marketing Start Date	2020-09-24
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL af5a9c74-e1c7-6574-e053-2995a90a3d10 Details

SPL UNCLASSIFIED SECTION

Inactive Ingredient: Ethyl alcohol 30%.

SPL UNCLASSIFIED SECTION

Temporarily relieves inflammatory symptoms of various origins such as:

fever
minor aches and pains

QUESTIONS

Questions?

[email protected]

(484) 223-3500

WARNINGS

Keep this and all medicines out of reach of children

DIRECTIONS

Take 15 minutes before meals

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 overdose, seek professional assistance or contact a Poison Control Center immediately.
Contains ethyl alcohol 30%

ACTIVE INGREDIENTS/PURPOSE

Arnica montana 3X Relieves inflammation

Bryonia 6X, 12X, 30X, 200X Relieves muscle and joint pain

Echinacea 4X Relieves inflammation

Ferrum phosphoricum 6X, 12X, 30X, 200X Relieves fever

Hepar suis 6X Detoxification

Hepar sulphuris calc. 6X, 12X, 30X, 200X Relieves inflammation

Hypophysis suis 200X Supports cell metabolism

Phytolacca decandra 6X, 12X, 30X, 200X Relieves swollen, inflamed lymph nodes

Pyrogenium 30X, 200X Relieves inflammation and fever

Chamomilla 2X Relieves inflammation

Apis mellifica 6X, 12X, 30X, 200X Relieves inflammation

Aconitum napellus 6X, 12X, 30X, 200X Relieves inflammation and fever

Belladonna 6X, 12X, 30X, 200X Relieves inflammation and fever

Cuprum carbonicum 4X Relieves back pain

Natrum pyruvicum 3X Supports cell metabolism

Citricum acidum 3X Antioxidant

SPL UNCLASSIFIED SECTION

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

Children between 12 and 6 years of age: 10 drops in a little water, 2 times per day

Children under 6 years: consult a physician

PREGNANCY

If pregnant or breast-feeding ask a doctor before use

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

GUNA FLAM RELIEF

aconitum napellus - apis mellifera - arnica montana whole - atropa belladonna - basic cupric carbonate - bryonia alba root - matricaria chamomilla whole - calcium sulfide - citric acid monohydrate - echinacea angustifolia - ferric phosphate - phytolacca americana root - rancid beef - sodium pyruvate - pork liver - rancid beef - sus scrofa pituitary gland - solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:17089-464
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW)	ARNICA MONTANA	3 [hp_X] in 30 mL
ECHINACEA ANGUSTIFOLIA WHOLE (UNII: VB06AV5US8) (ECHINACEA ANGUSTIFOLIA WHOLE - UNII:VB06AV5US8)	ECHINACEA ANGUSTIFOLIA WHOLE	4 [hp_X] in 30 mL
RANCID BEEF (UNII: 29SUH5R3HU) (RANCID BEEF - UNII:29SUH5R3HU)	RANCID BEEF	30 [hp_X] in 30 mL
BASIC CUPRIC CARBONATE (UNII: GIK928GH0Y) (CUPRIC CATION - UNII:8CBV67279L)	BASIC CUPRIC CARBONATE	4 [hp_X] in 30 mL
MATRICARIA CHAMOMILLA WHOLE (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA WHOLE - UNII:G0R4UBI2ZZ)	MATRICARIA CHAMOMILLA WHOLE	2 [hp_X] in 30 mL
ACONITUM NAPELLUS WHOLE (UNII: U0NQ8555JD) (ACONITUM NAPELLUS WHOLE - UNII:U0NQ8555JD)	ACONITUM NAPELLUS WHOLE	6 [hp_X] in 30 mL
APIS MELLIFERA (UNII: 7S82P3R43Z) (APIS MELLIFERA - UNII:7S82P3R43Z)	APIS MELLIFERA	6 [hp_X] in 30 mL
ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H)	ATROPA BELLADONNA	6 [hp_X] in 30 mL
BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B)	BRYONIA ALBA ROOT	6 [hp_X] in 30 mL
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL)	ANHYDROUS CITRIC ACID	3 [hp_X] in 30 mL
FERRIC PHOSPHATE (UNII: N6BAA189V1) (FERRIC CATION - UNII:91O4LML611)	FERRIC CATION	12 [hp_X] in 30 mL
CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q)	CALCIUM SULFIDE	6 [hp_X] in 30 mL
SODIUM PYRUVATE (UNII: POD38AIF08) (PYRUVIC ACID - UNII:8558G7RUTR)	SODIUM PYRUVATE	3 [hp_X] in 30 mL
PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG) (PHYTOLACCA AMERICANA ROOT - UNII:11E6VI8VEG)	PHYTOLACCA AMERICANA ROOT	6 [hp_X] in 30 mL
PORK LIVER (UNII: 6EC706HI7F) (PORK LIVER - UNII:6EC706HI7F)	PORK LIVER	6 [hp_X] in 30 mL
SUS SCROFA PITUITARY GLAND (UNII: L0PFEMQ1DT) (SUS SCROFA PITUITARY GLAND - UNII:L0PFEMQ1DT)	SUS SCROFA PITUITARY GLAND	200 [hp_X] in 30 mL

Ingredient Name	Strength
Inactive Ingredients
ALCOHOL (UNII: 3K9958V90M)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:17089-464-18	1 in 1 BOX	09/24/2020
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		09/24/2020

Labeler - Guna spa (430538264)

Name	Address	ID/FEI	Business Operations
Establishment
Guna spa		338587646	manufacture(17089-464)

Revised: 9/2020

Document Id: af5aec5c-a562-6516-e053-2a95a90a3be9

Set id: af5a9c74-e1c7-6574-e053-2995a90a3d10

Version: 1

Effective Time: 20200915

Search by Drug Name or NDC

NDC 17089-0464-18 GUNA FLAM RELIEF 6; 6; 3; 6; 4; 6; 6; 3; 4; 12; 2; 6; 6; 30; 3; 200 [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; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL Details

GUNA FLAM RELIEF 6; 6; 3; 6; 4; 6; 6; 3; 4; 12; 2; 6; 6; 30; 3; 200 [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; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL

Product Information

Package

Package Images

NDC 17089-0464-18 (17089046418)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL af5a9c74-e1c7-6574-e053-2995a90a3d10 Details

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

QUESTIONS

WARNINGS

DIRECTIONS

WARNINGS

ACTIVE INGREDIENTS/PURPOSE

SPL UNCLASSIFIED SECTION

PREGNANCY

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

Plavix (Clopidogrel) With Olive Oil Dosing Question

Can You Take A Z-Pak If You Have A Penicillin Allergy?