FDA.reportPublic FDA data

GUNA FLAM RELIEF

Manufacturer
Guna spa
Effective date
2020-09-15
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:13:26

Label at a glance#

ProductGUNA FLAM RELIEF
Active ingredientARNICA MONTANA, ECHINACEA ANGUSTIFOLIA WHOLE, RANCID BEEF, BASIC CUPRIC CARBONATE, MATRICARIA CHAMOMILLA WHOLE, ACONITUM NAPELLUS WHOLE, APIS MELLIFERA, ATROPA BELLADONNA, BRYONIA ALBA ROOT, CITRIC ACID MONOHYDRATE, FERRIC PHOSPHATE, CALCIUM SULFIDE, SODIUM PYRUVATE, PHYTOLACCA AMERICANA ROOT, PORK LIVER, SUS SCROFA PITUITARY GLAND
Label structure10 sections

Dosage and administration

Take 15 minutes before meals

Label contents#

Full prescribing information#

INACTIVE INGREDIENT SECTION

Inactive Ingredient: Ethyl alcohol 30%.

OTC - PURPOSE SECTION

Temporarily relieves inflammatory symptoms of various origins such as:

  • fever
  • minor aches and pains

QUESTIONS

OTC - QUESTIONS SECTION

Questions?

info@gunainc.com

(484) 223-3500

WARNINGS

OTC - KEEP OUT OF REACH OF CHILDREN SECTION



Keep this and all medicines out of reach of children

DIRECTIONS

INDICATIONS & USAGE SECTION

Take 15 minutes before meals










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

ACTIVE INGREDIENTS/PURPOSE

OTC - ACTIVE INGREDIENT SECTION

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

DOSAGE & ADMINISTRATION 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

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding ask a doctor before use

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

5USFLR5USFLR

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
04cdd491-d111-4bc2-9549-75c575e1bd4bProduct name120200714
8390fb8b-6c75-416c-a9a1-70e8ed493b73Product name120200611
96a528e9-23e2-495f-81b9-ae87df2f7552Product name120191120
3df56c93-5837-4523-aac2-4b1ec48b9676Product name220160719
a883b7cc-d320-41d7-92ae-c873457ae641Product name120151116
bb23e78e-9e64-4037-a1c1-0e1d8762700eProduct name120150325
ef06c001-572c-d95e-42f6-ee83da75673aProduct name120140508
fd21f957-6863-d07b-5a35-250186878716Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17089-464-18GUNA FLAM RELIEF30 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS301
17089-464-18GUNA FLAM RELIEF1 in 1 BOXSOLUTION/ DROPS11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17089-464GUNA 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 [GUNA SPA]1Current NDC, Legacy NDC, 2 package rows20201024_af5a9c74-e1c7-6574-e053-2995a90a3d10.zip

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
17089-46417089-464-18

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
ARNICA MONTANAO80TY208ZWACTIB
ECHINACEA ANGUSTIFOLIA WHOLEVB06AV5US8ACTIB
RANCID BEEF29SUH5R3HUACTIB
BASIC CUPRIC CARBONATEGIK928GH0YACTIB
MATRICARIA CHAMOMILLA WHOLEG0R4UBI2ZZACTIB
ACONITUM NAPELLUS WHOLEU0NQ8555JDACTIB
ALCOHOL3K9958V90MIACT
APIS MELLIFERA7S82P3R43ZACTIB
ATROPA BELLADONNAWQZ3G9PF0HACTIB
BRYONIA ALBA ROOTT7J046YI2BACTIB
CITRIC ACID MONOHYDRATE2968PHW8QPACTIM
FERRIC PHOSPHATEN6BAA189V1ACTIM
CALCIUM SULFIDE1MBW07J51QACTIB
SODIUM PYRUVATEPOD38AIF08ACTIB
PHYTOLACCA AMERICANA ROOT11E6VI8VEGACTIB
PORK LIVER6EC706HI7FACTIB
SUS SCROFA PITUITARY GLANDL0PFEMQ1DTACTIB

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 FLAM RELIEFACONITUM 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 -Guna spaaf5a9c74-e1c7-6574-e053-2995a90a3d102020-09-15WarningsExact identifier
ndc (package): 17089-464-18
ndc (product): 17089-464
ndc11 (package): 17089046418
spl id: af5aec5c-a562-6516-e053-2a95a90a3be9
spl set id: af5a9c74-e1c7-6574-e053-2995a90a3d10

Reported adverse events (FAERS/openFDA)#

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