FDA.reportPublic FDA data

GUNA-HEMORRHOIDS

Manufacturer
Guna spa
Effective date
2018-12-21
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:10:41

Label at a glance#

ProductGUNA-HEMORRHOIDS
Active ingredientAESCULUS HIPPOCASTANUM FLOWER, ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBIT, CANAKINUMAB, ARNICA MONTANA, ATROPA BELLADONNA, ACTIVATED CHARCOAL, HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK, PORK LIVER, HYDROCOTYLE ASIATICA EXTRACT, SUS SCROFA SMALL INTESTINE MUCOSA LYMPH FOLLICLE, MELISSA OFFICINALIS, STRYCHNOS NUX-VOMICA SEED, PAEONIA OFFICINALIS ROOT, PODOPHYLLUM PELTATUM ROOT, SUS SCROFA VEIN
Label structure10 sections

Indications and uses

Temporary relief of symptoms due to hemorrhoids such as: Pain Itching Burning

Dosage and administration

Adults and children 12 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 5 drops in a glass of water, 2 times per day

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS/PURPOSE

OTC - ACTIVE INGREDIENT SECTION

AESCULUS HIPPOCASTANUM        6C    VENOUS FLOW SUPPORT
ANTI INTERLEUKIN 1 ALPHA          4C    IMMUNE STRENGTHENING
ANTI INTERLEUKIN 1 BETA            4C    IMMUNE STRENGTHENING
ARNICA MONTANA                        6C    HEMORRHOIDAL ITCHING
BELLADONNA                                6C    ANTI-INFLAMMATORY
CARBO VEGETALIS                        10X    BOWEL DETOXIFICATION
HAMAMELIS VIRGINIANA                6C    HEMORRHOIDAL PAIN
HEPAR                                            6X, 12X, 30X    SUPPORTS LIVER DETOXIFICATION
HYDROCOTYLE ASIATICA                6C    PAIN RELIEF
LYMPHATIC VESSEL                       6X    PROMOTES LYMPH FLOW
MELISSA OFFICINALIS                    6C    DIGESTIVE
NUX VOMICA                                    6C    DIGESTIVE
PAEONIA OFFICINALIS                    6X    ANTIHEMORRHOIDAL
PODOPHYLLUM PELTATUM            4C    BOWEL ACTIVITY
VEIN                                                4C    VENOUS FLOW SUPPORT



USES

OTC - PURPOSE SECTION

Temporary relief of symptoms due to hemorrhoids such as:

  • Pain
  • Itching
  • Burning

WARNINGS

WARNINGS SECTION

Stop use and ask doctor if symptoms persist more than 5 days.
If pregnant or breast-feeding ask a health professional before use.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Contains ethyl alcohol 30%

PREGNANCY

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding ask a doctor before use.

WARNINGS

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION


Adults and children 12 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 5 drops in a glass of water, 2 times per day


QUESTIONS

OTC - QUESTIONS SECTION

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

INDICATIONS & USAGE SECTION

Take 15 minutes before meals.

INACTIVE INGREDIENT SECTION

Inactive ingredient: Ethyl alcohol 30%.

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

5USHEM-Rev03-02-05-185USHEM-Rev03-02-05-18

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
bd1801bf-1b8e-49c6-894d-a4af5821c1abProduct name120161129

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17089-296-18GUNA-HEMORRHOIDS30 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS302
17089-296-18GUNA-HEMORRHOIDS1 in 1 BOXSOLUTION/ DROPS12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17089-296GUNA-HEMORRHOIDS (ACTIVATED CHARCOAL - ARNICA MONTANA - ATROPA BELLADONNA - CANAKINUMAB - HYDROCOTYLE ASIATICA EXTRACT - AESCULUS HIPPOCASTANUM FLOWER - MELISSA OFFICINALIS - PAEONIA OFFICINALIS ROOT - PODOPHYLLUM PELTATUM ROOT - PORK LIVER - STRYCHNOS NUX-VOMICA SEED - SUS SCROFA SMALL INTESTINE MUCOSA LYMPH FOLLICLE - SUS SCROFA VEIN - HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK - ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBIT -) SOLUTION/ DROPS [GUNA SPA]2Current NDC, Legacy NDC, 2 package rows20190104_0fd0dcef-79c6-4489-a533-996aa5331d9c.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ACTIVATED CHARCOALACTIVE INGREDIENT2P3VWU3H101
AESCULUS HIPPOCASTANUM FLOWERACTIVE INGREDIENTKK0Z92II8M1
ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBITACTIVE INGREDIENTML4QRZ1HCL1
ARNICA MONTANAACTIVE INGREDIENTO80TY208ZW1
ATROPA BELLADONNAACTIVE INGREDIENTWQZ3G9PF0H1
CANAKINUMABACTIVE INGREDIENT37CQ2C7X931
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARKACTIVE INGREDIENTT7S323PKJS1
HYDROCOTYLE ASIATICA EXTRACTACTIVE INGREDIENT6810070TYD1
MELISSA OFFICINALISACTIVE INGREDIENTYF70189L0N1
PAEONIA OFFICINALIS ROOTACTIVE INGREDIENT8R564U2E1P1
PODOPHYLLUM PELTATUM ROOTACTIVE INGREDIENT2S713A4VP31
PORK LIVERACTIVE INGREDIENT6EC706HI7F1
STRYCHNOS NUX-VOMICA SEEDACTIVE INGREDIENT269XH139191
SUS SCROFA SMALL INTESTINE MUCOSA LYMPH FOLLICLEACTIVE INGREDIENT308LM01C721
SUS SCROFA VEINACTIVE INGREDIENT2510RH3I891
ACTIVATED CHARCOALACTIVE MOIETY2P3VWU3H101
AESCULUS HIPPOCASTANUM FLOWERACTIVE MOIETYKK0Z92II8M1
ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBITACTIVE MOIETYML4QRZ1HCL1
ARNICA MONTANAACTIVE MOIETYO80TY208ZW1
ATROPA BELLADONNAACTIVE MOIETYWQZ3G9PF0H1
CANAKINUMABACTIVE MOIETY37CQ2C7X931
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARKACTIVE MOIETYT7S323PKJS1
HYDROCOTYLE ASIATICA EXTRACTACTIVE MOIETY6810070TYD1
MELISSA OFFICINALISACTIVE MOIETYYF70189L0N1
PAEONIA OFFICINALIS ROOTACTIVE MOIETY8R564U2E1P1
PODOPHYLLUM PELTATUM ROOTACTIVE MOIETY2S713A4VP31
PORK LIVERACTIVE MOIETY6EC706HI7F1
STRYCHNOS NUX-VOMICA SEEDACTIVE MOIETY269XH139191
SUS SCROFA SMALL INTESTINE MUCOSA LYMPH FOLLICLEACTIVE MOIETY308LM01C721
SUS SCROFA VEINACTIVE MOIETY2510RH3I891
ALCOHOLINACTIVE INGREDIENT3K9958V90M1

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
17089-29617089-296-18

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MIACT
AESCULUS HIPPOCASTANUM FLOWERKK0Z92II8MACTIB
ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBITML4QRZ1HCLACTIB
CANAKINUMAB37CQ2C7X93ACTIB
ARNICA MONTANAO80TY208ZWACTIB
ATROPA BELLADONNAWQZ3G9PF0HACTIB
ACTIVATED CHARCOAL2P3VWU3H10ACTIB
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARKT7S323PKJSACTIB
PORK LIVER6EC706HI7FACTIB
HYDROCOTYLE ASIATICA EXTRACT6810070TYDACTIB
SUS SCROFA SMALL INTESTINE MUCOSA LYMPH FOLLICLE308LM01C72ACTIB
MELISSA OFFICINALISYF70189L0NACTIB
STRYCHNOS NUX-VOMICA SEED269XH13919ACTIB
PAEONIA OFFICINALIS ROOT8R564U2E1PACTIB
PODOPHYLLUM PELTATUM ROOT2S713A4VP3ACTIB
SUS SCROFA VEIN2510RH3I89ACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 22 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
ALCOHOLALCOHOL3K9958V90MCAPSULE, EXTENDED RELEASE / ORAL8 mgExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MELIXIR / ORAL13675 mgExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSYRUP / ORAL21000 mgExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MTABLET, DELAYED RELEASE / ORALNAExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MTABLET, DELAYED RELEASE / ORALNAExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCONCENTRATE / ORAL198 mgExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION, CONCENTRATE / ORAL150.68 mg/1mlExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MELIXIR / ORAL13675 mgExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCAPSULE / ORAL882 mgExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSYRUP / ORAL21000 mgExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / ORAL6624 mgExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / ORAL6624 mgExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION, CONCENTRATE / ORAL150.68 mg/1mlExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MDROPS / ORAL210 mg/1mlExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCAPSULE, EXTENDED RELEASE / ORAL8 mgExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSUSPENSION / ORAL681 mgExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCONCENTRATE / ORAL198 mgExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCAPSULE / ORAL882 mgExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MDROPS / ORAL210 mg/1mlExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSUSPENSION / ORAL681 mgExact identifier — unii+route
22 equally ranked IID candidates

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-HEMORRHOIDSACTIVATED CHARCOAL - ARNICA MONTANA - ATROPA BELLADONNA - CANAKINUMAB - HYDROCOTYLE ASIATICA EXTRACT - AESCULUS HIPPOCASTANUM FLOWER - MELISSA OFFICINALIS - PAEONIA OFFICINALIS ROOT - PODOPHYLLUM PELTATUM ROOT - PORK LIVER - STRYCHNOS NUX-VOMICA SEED - SUS SCROFA SMALL INTESTINE MUCOSA LYMPH FOLLICLE - SUS SCROFA VEIN - HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK - ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBIT -Guna spa0fd0dcef-79c6-4489-a533-996aa5331d9c2018-12-21WarningsExact identifier
ndc (package): 17089-296-18
ndc (product): 17089-296
ndc11 (package): 17089029618
spl id: 7e8f9d55-ff6d-cbe7-e053-2a91aa0a382e
spl set id: 0fd0dcef-79c6-4489-a533-996aa5331d9c

Reported adverse events (FAERS/openFDA)#

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