FDA.reportPublic FDA data

Hemorrhoidal

Manufacturer
Major Pharmaceuticals | DSC Laboratories Inc.
Effective date
2025-10-16
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
monthly-update
Hydrated at
2026-06-03 17:39:33

Label at a glance#

ProductHemorrhoidal
Active ingredientHARD FAT, PHENYLEPHRINE HYDROCHLORIDE
Label structure8 sections

Indications and uses

temporarily shrinks hemorrhoidal tissue gives temporary relief to the itching, burning and discomfort associated with hemorrhoids

Dosage and administration

when practical, cleanse the affected area by patting or blotting with an appropriate cleansing wipe. gently dry by patting or blotting with a tissue or a soft cloth before insertion of suppository. detach on suppository from the strip separate the two tabs of the white plastic wrap with thumb and forefinger of each hand, grasp the tabs and peel downward, unwrapping the suppository insert one suppository into the r...

Label contents#

Full prescribing information#

Active Ingredients (in each suppository)

OTC - ACTIVE INGREDIENT SECTION

Hard Fat 88.44%

Phenylephrine hydrochloride 0.25%

Purpose

OTC - PURPOSE SECTION

Protectant

Vasoconstrictor

Uses

INDICATIONS & USAGE SECTION

  • temporarily shrinks hemorrhoidal tissue
  • gives temporary relief to the itching, burning and discomfort associated with hemorrhoids

Warnings

WARNINGS SECTION

For rectal use only

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • heart disease
  • thyroid disease
  • high blood pressure
  • diabetes
  • trouble urinating due to an enlargedprostate gland

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

presently taking a prescription drug for high blood pressure or depression

When using this product,

OTC - WHEN USING SECTION

do not use more than directed

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • bleeding occurs
  • condition worsens or does not improve within 7 days

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • when practical, cleanse the affected area by patting or blotting with an appropriate cleansing wipe.
  • gently dry by patting or blotting with a tissue or a soft cloth before insertion of suppository.
  • detach on suppository from the strip
  • separate the two tabs of the white plastic wrap
  • with thumb and forefinger of each hand, grasp the tabs and peel downward, unwrapping the suppository
  • insert one suppository into the rectum

adults and children 12 years and over: insert one suppository rectally up to 4 times daily

children under 12 years: ask a doctor

Other information

OTHER SAFETY INFORMATION

store below 30ºC (86ºF) to avoid melting.

Inactive ingredients

INACTIVE INGREDIENT SECTION

corn starch, methylparaben, propylparaben

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Major Hem SuppositoriesMajor Hem SuppositoriesThe product package shown above represents a sample of that currently in use. Additional packaging may also be available.

Major Hemorrhoidal Suppositories 12ct

Distributed by

Major Pharmaceuticals

17177 N. Laurel Park Drive

Suite 233

Livonia, MI 48152

MajorHemSupp.jpg

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130309046977124GTIN-13: 0309046977124
EAN-13: 0309046977124
GTIN-12: 309046977124
UPC-A: 309046977124
GTIN storage (14 digits): 00309046977124		MajorHemSupp.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-6977-12EA - Each0904-69778704a4b1-7b18-4526-ad8f-2d2b6f4d91c112020-01-03

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0904-69770904-6977-12

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
STARCH, CORNO8232NY3SJIACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLPARABENZ8IX2SC1OHIACT
HARD FAT8334LX7S21ACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
72025-08-01full-release2026-06-01 01:09:11

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
4147cf4c-41a8-35ec-e063-6394a90a797099fcda73-472f-d5fe-e053-2995a90a9fa42025-10-16WarningsExact identifier
spl id: 4147cf4c-41a8-35ec-e063-6394a90a7970
spl set id: 99fcda73-472f-d5fe-e053-2995a90a9fa4

Reported adverse events (FAERS/openFDA)#

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