MedPath

Hemorrhoidal

Major Hemorrhoidal Suppositories

Approved
Approval ID

99fcda73-472f-d5fe-e053-2995a90a9fa4

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Aug 1, 2025

Manufacturers
FDA

Major Pharmaceuticals

DUNS: 191427277

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Hard Fat, Phenylephrine HCl

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0904-6977
Application NumberM015
Product Classification
M
Marketing Category
C200263
G
Generic Name
Hard Fat, Phenylephrine HCl
Product Specifications
Route of AdministrationRECTAL
Effective DateAugust 1, 2025
FDA Product Classification

INGREDIENTS (5)

STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
HARD FATActive
Quantity: 1.77 g in 1 1
Code: 8334LX7S21
Classification: ACTIB
PHENYLEPHRINE HYDROCHLORIDEActive
Quantity: 5 mg in 1 1
Code: 04JA59TNSJ
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 12/18/2019

Major 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

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 12/18/2019

Uses

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

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 12/18/2019

Active Ingredients (in each suppository)

Hard Fat 88.44%

Phenylephrine hydrochloride 0.25%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 12/18/2019

Purpose

Protectant

Vasoconstrictor

WARNINGS SECTION

LOINC: 34071-1Updated: 12/18/2019

Warnings

For rectal use only

Ask a doctor before use if you have

  • 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

presently taking a prescription drug for high blood pressure or depression

When using this product,

do not use more than directed

Stop use and ask a doctor if

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

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

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

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 12/18/2019

Directions

  • 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 SAFETY INFORMATION

LOINC: 60561-8Updated: 12/18/2019

Other information

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

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 12/18/2019

Inactive ingredients

corn starch, methylparaben, propylparaben

RECENT MAJOR CHANGES SECTION

LOINC: 43683-2Updated: 12/18/2019

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Hemorrhoidal - FDA Drug Approval Details