FDA.reportPublic FDA data

GUNA PAIN MANAGEMENT

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 PAIN MANAGEMENT
Active ingredientBRYONIA ALBA ROOT, HISTAMINE DIHYDROCHLORIDE, HYPERICUM PERFORATUM, ARNICA MONTANA WHOLE, PORK LIVER, BELLIS PERENNIS WHOLE, MATRICARIA CHAMOMILLA WHOLE, TOXICODENDRON PUBESCENS LEAF, RUTA GRAVEOLENS FLOWERING TOP, KALMIA LATIFOLIA LEAF, ACHILLEA MILLEFOLIUM WHOLE, COMFREY ROOT, APIS MELLIFERA
Label structure10 sections

Indications and uses

Relieves swelling and pain in cases of: muscle aches, cramps minor injuries, bruises toothache

Dosage and administration

Take 15 minutes before meals. Adults and children twelve years and older: 20 drops in a little water, 2 times per day Children between 12 years and 6 years of age: 10 drops in a little water, 2 times per day Children under 6 years: consult a physician

Label contents#

Full prescribing information#

INACTIVE INGREDIENT SECTION

Inactive ingredient: Ethyl alcohol 30%.

QUESTIONS

OTC - QUESTIONS SECTION

Questions?

info@gunainc.com

Tel. (484) 223-3500


WARNINGS

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

INDICATIONS & USAGE SECTION

Take 15 minutes before meals.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

Take 15 minutes before meals.

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

Children between 12 years 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 health care profesisonal before use.

WARNINGS

WARNINGS SECTION

  • Stop use and ask doctor if symptoms worsen or 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%

ACTIVE INGREDIENTS/PURPOSE

OTC - ACTIVE INGREDIENT SECTION

Millefolium 2X Relieves pain

Bellis perennis 2X Relieves muscle soreness, sprains

Apis mellifica 30X Helps reduce swelling

Bryonia 6X Relieves muscle and joint pain

Chamomilla 2X Relieves inflammation

Histaminum hydroc. 12X Relieves burning, redness

Hepar suis 6X Relieves pain

Hypericum perf. 3X Relieves pain

Kalmia latifolia 6X Relieves pain

Rhus tox 8X Relieves pain

Ruta graveolens 4X Relieves pain

Symphytum officinale 6X Relieves pain

Arnica montana 3X Relieves inflammation

USES

OTC - PURPOSE SECTION

Relieves swelling and pain in cases of:

  • muscle aches, cramps
  • minor injuries, bruises
  • toothache

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

5USPAM5USPAM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17089-465-18GUNA PAIN MANAGEMENT30 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS301
17089-465-18GUNA PAIN MANAGEMENT1 in 1 BOXSOLUTION/ DROPS11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17089-465GUNA PAIN MANAGEMENT (ACHILLEA MILLEFOLIUM WHOLE - BELLIS PERENNIS WHOLE - MATRICARIA CHAMOMILLA WHOLE - TOXICODENDRON PUBESCENS WHOLE - RUTA GRAVEOLENS FLOWERING TOP - COMFREY ROOT - APIS MELLIFERA - BRYONIA ALBA ROOT - HISTAMINE HYDROCHLORIDE - HYPERICUM PERFORATUM - KALMIA LATIFOLIA LEAF - ARNICA MONTANA WHOLE - PORK LIVER -) SOLUTION/ DROPS [GUNA SPA]1Current NDC, Legacy NDC, 2 package rows20201024_af5bad63-6d57-2260-e053-2995a90afb7e.zip

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
17089-46517089-465-18

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
BRYONIA ALBA ROOTT7J046YI2BACTIB
HISTAMINE DIHYDROCHLORIDE3POA0Q644UACTIB
HYPERICUM PERFORATUMXK4IUX8MNBACTIB
ARNICA MONTANA WHOLEO80TY208ZWACTIB
PORK LIVER6EC706HI7FACTIB
BELLIS PERENNIS WHOLE2HU33I03UYACTIB
MATRICARIA CHAMOMILLA WHOLEG0R4UBI2ZZACTIB
TOXICODENDRON PUBESCENS LEAF6IO182RP7AACTIB
RUTA GRAVEOLENS FLOWERING TOPN94C2U587SACTIB
KALMIA LATIFOLIA LEAF79N6542N18ACTIB
ALCOHOL3K9958V90MIACT
ACHILLEA MILLEFOLIUM WHOLE2FXJ6SW4PKACTIB
COMFREY ROOTM9VVZ08EKQACTIB
APIS MELLIFERA7S82P3R43ZACTIB

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 PAIN MANAGEMENTACHILLEA MILLEFOLIUM WHOLE - BELLIS PERENNIS WHOLE - MATRICARIA CHAMOMILLA WHOLE - TOXICODENDRON PUBESCENS WHOLE - RUTA GRAVEOLENS FLOWERING TOP - COMFREY ROOT - APIS MELLIFERA - BRYONIA ALBA ROOT - HISTAMINE HYDROCHLORIDE - HYPERICUM PERFORATUM - KALMIA LATIFOLIA LEAF - ARNICA MONTANA WHOLE - PORK LIVER -Guna spaaf5bad63-6d57-2260-e053-2995a90afb7e2020-09-15WarningsExact identifier
ndc (package): 17089-465-18
ndc (product): 17089-465
ndc11 (package): 17089046518
spl id: af5b9acf-ede8-0899-e053-2a95a90a1706
spl set id: af5bad63-6d57-2260-e053-2995a90afb7e

Reported adverse events (FAERS/openFDA)#

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