SEVERE HEMORRHOIDS

Manufacturer: HOMEOLAB USA INC
Effective date: 2012-11-21
Label type: HUMAN OTC DRUG LABEL
Version: 3
Source: legacy-cache
Hydrated at: 2026-08-02 01:42:13

Label at a glance#

ProductSEVERE HEMORRHOIDS REAL RELIEF

Active ingredientPAEONIA OFFICINALIS ROOT, KRAMERIA LAPPACEA ROOT, NITRIC ACID, SULFUR, PODOPHYLLUM, RUTA GRAVEOLENS FLOWERING TOP, GRAPHITE, APIS MELLIFERA, HORSE CHESTNUT, STRYCHNOS NUX-VOMICA SEED

Label structure9 sections

Indications and uses

This homeopathic medicine helps relieve hemorrhoidal symptoms: - external/internal discomfort - swollen tissue - irritation

Dosage and administration

Chew tablets and let dissolve in mouth. Do not use more than directed. Do not take with food. Repeat 3 times daily and reduce with improvement or as directed by a health professional. Age Dose Adults and children 12 years of age and older 2 tablets Children 2 to 11 years of age 1 tablet Children under 2 years of age Ask a doctor

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS HPUS

OTC - ACTIVE INGREDIENT SECTION

Paeonia officinalis (Peony) 8X
Ratanhia (Rhatany) 8X
Nitricum acidum (Nitric acid) 8X
Sulphur (Sublimed sulfur) 8X
Podophyllum peltatum (Mayapple) 8X
Ruta graveolens (Rue) 8X
Graphites (Plumbago) 8X
Apis mellifica (Honeybee) 8X
Aesculus hippocastanum (Horse chesnut) 8X
Nux vomica (Poison nut) 8X

REFERENCES SECTION

The letters 'HPUS' indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.

PURPOSE

OTC - PURPOSE SECTION

hemorrhoids with ulceration
rectal pain, irritation
painless or burning hemorrhoids
inflammation, swollen tissue
external/internal discomfort, irritation
rectal pain
painful burning tissue with fissures
swollen rectal tissue
painful hemorrhoids
itching and bleeding hemorrhoids

USES

INDICATIONS & USAGE SECTION

This homeopathic medicine helps relieve hemorrhoidal symptoms:

- external/internal discomfort

- swollen tissue

- irritation

WARNINGS

WARNINGS SECTION

OTC - STOP USE SECTION

Stop use and ask a doctor if symptoms worsen or persist for more than 7 days.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

Chew tablets and let dissolve in mouth.

Do not use more than directed.

Do not take with food.

Repeat 3 times daily and reduce with improvement or as directed by a health professional.

Age	Dose
Adults and children 12 years of age and older	2 tablets
Children 2 to 11 years of age	1 tablet
Children under 2 years of age	Ask a doctor

OTHER INFORMATION

OTHER SAFETY INFORMATION

Store at room temperature (68 - 77F).

Do not use if seal is broken or missing.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Lactose, magnesium stearate.

CARTON

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image description

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
60512-6038-0	2025-12-29	C162847	48780-1	9d75b9d0-0f8e-f424-e053-dadaa90a57ce	DRUG FACTS
60512-6038-0	2020-01-31	C162847	48780-1	9d75b9d0-0f8e-f424-e053-dadaa90a57ce	DRUG FACTS

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
60512-6038	SEVERE HEMORRHOIDS REAL RELIEF (PAEONIA OFFICINALIS, RATANHIA, NITRICUM ACIDUM, SULFUR, PODOPHYLLUM PELTATUM, RUTA GRAVEOLENS, GRAPHITES, APIS MELLIFICA, AESCULUS HIPPOCASTANUM, NUX VOMICA) TABLET, CHEWABLE [HOMEOLAB USA INC]	3	Legacy NDC	20130117_dd23f58b-1ca5-4c24-8ee9-8a9be4443a2a.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
APIS MELLIFERA	ACTIVE INGREDIENT	7S82P3R43Z	3
GRAPHITE	ACTIVE INGREDIENT	4QQN74LH4O	3
HORSE CHESTNUT	ACTIVE INGREDIENT	3C18L6RJAZ	3
KRAMERIA LAPPACEA ROOT	ACTIVE INGREDIENT	P29ZH1A35Z	3
NITRIC ACID	ACTIVE INGREDIENT	411VRN1TV4	3
PAEONIA OFFICINALIS ROOT	ACTIVE INGREDIENT	8R564U2E1P	3
PODOPHYLLUM	ACTIVE INGREDIENT	2S713A4VP3	3
RUTA GRAVEOLENS FLOWERING TOP	ACTIVE INGREDIENT	N94C2U587S	3
STRYCHNOS NUX-VOMICA SEED	ACTIVE INGREDIENT	269XH13919	3
SULFUR	ACTIVE INGREDIENT	70FD1KFU70	3
APIS MELLIFERA	ACTIVE MOIETY	7S82P3R43Z	3
GRAPHITE	ACTIVE MOIETY	4QQN74LH4O	3
HORSE CHESTNUT	ACTIVE MOIETY	3C18L6RJAZ	3
KRAMERIA LAPPACEA ROOT	ACTIVE MOIETY	P29ZH1A35Z	3
NITRIC ACID	ACTIVE MOIETY	411VRN1TV4	3
PAEONIA OFFICINALIS ROOT	ACTIVE MOIETY	8R564U2E1P	3
PODOPHYLLUM	ACTIVE MOIETY	2S713A4VP3	3
RUTA GRAVEOLENS FLOWERING TOP	ACTIVE MOIETY	N94C2U587S	3
STRYCHNOS NUX-VOMICA SEED	ACTIVE MOIETY	269XH13919	3
SULFUR	ACTIVE MOIETY	70FD1KFU70	3
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	3

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

SEVERE HEMORRHOIDS REAL RELIEF
PAEONIA OFFICINALIS, RATANHIA, NITRICUM ACIDUM, SULFUR, PODOPHYLLUM PELTATUM, RUTA GRAVEOLENS, GRAPHITES, APIS MELLIFICA, AESCULUS HIPPOCASTANUM, NUX VOMICA
PAEONIA OFFICINALIS ROOT
KRAMERIA LAPPACEA ROOT
NITRIC ACID
SULFUR
PODOPHYLLUM
RUTA GRAVEOLENS FLOWERING TOP
GRAPHITE
APIS MELLIFERA
HORSE CHESTNUT
STRYCHNOS NUX-VOMICA SEED
LACTOSE
MAGNESIUM STEARATE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
60512-6038	60512-6038-0

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
PAEONIA OFFICINALIS ROOT	8R564U2E1P	ACTIB
KRAMERIA LAPPACEA ROOT	P29ZH1A35Z	ACTIB
NITRIC ACID	411VRN1TV4	ACTIB
SULFUR	70FD1KFU70	ACTIB
PODOPHYLLUM	2S713A4VP3	ACTIB
RUTA GRAVEOLENS FLOWERING TOP	N94C2U587S	ACTIB
GRAPHITE	4QQN74LH4O	ACTIB
APIS MELLIFERA	7S82P3R43Z	ACTIB
HORSE CHESTNUT	3C18L6RJAZ	ACTIB
STRYCHNOS NUX-VOMICA SEED	269XH13919	ACTIB
LACTOSE	J2B2A4N98G	IACT
MAGNESIUM STEARATE	70097M6I30	IACT

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 2 · 75 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	WAFER / ORAL	66 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	INJECTION / INTRAVENOUS	203.5 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		47 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	POWDER / VAGINAL	430 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	CREAM / VAGINAL	3 %w/w		Exact identifier — unii candidate 36 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, ORALLY DISINTEGRATING / ORAL		187 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	IMPLANT / INTRAVITREAL	NA		Exact identifier — unii candidate 39 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	CAPSULE, EXTENDED RELEASE / ORAL	120 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	INJECTION, SOLUTION / INTRAVENOUS	0.45 %w/v		Exact identifier — unii candidate 36 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	GRANULE / ORAL		629 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRACAVITARY	193.8 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET, FILM COATED / ORAL	590 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET, CHEWABLE / ORAL		1412 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET / ORAL		980 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	CREAM / TOPICAL	NA		Exact identifier — unii candidate 39 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	GRANULE, FOR SUSPENSION / ORAL		14 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	POWDER, FOR SUSPENSION / ORAL		120 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET / SUBLINGUAL		352 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	CAPSULE / RESPIRATORY (INHALATION)	44.4 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	SUSPENSION / ORAL		64 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	CAPSULE, DELAYED RELEASE / ORAL	231.84 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	CAPSULE / ORAL	256.4 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	LOZENGE / ORAL		420 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET, EXTENDED RELEASE / ORAL	400 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS	133 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET / SUBLINGUAL	17.5 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	CONCENTRATE / ORAL	NA		Exact identifier — unii candidate 36 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, FILM COATED / ORAL		96 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, CHEWABLE, EXTENDED RELEASE / ORAL		9 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET / BUCCAL	17.5 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		620 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	CAPSULE / ORAL	530 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	IMPLANT / SUBCUTANEOUS	0.5 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	SUSPENSION, EXTENDED RELEASE / ORAL		71 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, FOR SUSPENSION / ORAL		131 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR	133 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	INHALANT / ORAL	0.08 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	CAPSULE, COATED PELLETS / ORAL	135.2 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	CAPSULE, DELAYED RELEASE / ORAL		1060 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	POWDER / ORAL		25 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	INJECTION, POWDER, FOR SOLUTION / SUBCUTANEOUS	133 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	POWDER, FOR SOLUTION / ORAL	NA		Exact identifier — unii candidate 36 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		53 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	POWDER / TOPICAL		104 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	RING / VAGINAL		2 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	INSERT / VAGINAL		69 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET, COATED / ORAL	332.05 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	SOLUTION / ORAL	1682 mg/15ml		Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET, EFFERVESCENT / ORAL	96.5 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	LOZENGE / TRANSMUCOSAL		100 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	SOLUTION / RECTAL	8 %w/v		Exact identifier — unii candidate 36 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, DELAYED RELEASE / ORAL		144 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET, DELAYED RELEASE / ORAL		160 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	POWDER / RESPIRATORY (INHALATION)	90 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET / BUCCAL	296.7 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	DROPS / ORAL	NA		Exact identifier — unii candidate 39 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 36 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, SUGAR COATED / ORAL	NA		Exact identifier — unii candidate 39 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	GRANULE, FOR SUSPENSION / ORAL	512.5 mg/5ml		Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET / RECTAL	20 mg		Exact identifier — unii candidate 36 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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
4718d4c2-5106-e825-e063-6394a90a3d68			dd23f58b-1ca5-4c24-8ee9-8a9be4443a2a	2025-12-29	Warnings	Exact identifier spl set id: dd23f58b-1ca5-4c24-8ee9-8a9be4443a2a

Reported adverse events (FAERS/openFDA)#

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