Hemorrhoidal
Major Hemorrhoidal Suppositories
99fcda73-472f-d5fe-e053-2995a90a9fa4
HUMAN OTC DRUG LABEL
Aug 1, 2025
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
Product Classification
Product Specifications
INGREDIENTS (5)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
The 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
Uses
- temporarily shrinks hemorrhoidal tissue
- gives temporary relief to the itching, burning and discomfort associated with hemorrhoids
OTC - ACTIVE INGREDIENT SECTION
Active Ingredients (in each suppository)
Hard Fat 88.44%
Phenylephrine hydrochloride 0.25%
OTC - PURPOSE SECTION
Purpose
Protectant
Vasoconstrictor
WARNINGS SECTION
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
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
Other information
store below 30ºC (86ºF) to avoid melting.
INACTIVE INGREDIENT SECTION
Inactive ingredients
corn starch, methylparaben, propylparaben