Drug Facts

Drug Facts
SPL v4
SPL
SPL Set ID 96d2e0e7-2de0-4660-9ffd-9edb2ad224d8
Route
RECTAL
Published
Effective Date 2025-04-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Phenylephrine (6.25 mg)
Inactive Ingredients
Cocoa Butter Starch, Corn Methylparaben Propylparaben

Identifiers & Packaging

Pill Appearance
Shape: bullet Color: yellow Size: 32 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-12-16

Description

Phenylephrine HCl 0.25%

Purpose

Vasoconstrictor


Medication Information

Purpose

Vasoconstrictor

Description

Phenylephrine HCl 0.25%

Uses
  • helps relieve the local itching and discomfort associated with hemorrhoids
  • temporarily shrinks hemorrhoidal tissue
  • temporarily reduces the swelling associated with irritation in hemorrhoids and other anorectal disorders
Warnings

For rectal use only

Directions
  • adults: 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 this product.
  • detach one suppository from the strip; remove the foil wrapper before inserting into the rectum as follows:
    • hold suppository with the rounded end up
    • as shown, carefully separate foil tabs by inserting tip of fingernail at end marked “peel down”
    • slowly and evenly peel apart (do not tear) foil by pulling tabs down both sides, to expose the suppository
    • remove exposed suppository from the wrapper
    • insert one suppository into the rectum up to 4 times daily, especially at night, in the morning or after each bowel movement
  • children under 12 years of age: consult a doctor
Active Ingredient

Phenylephrine HCl 0.25%

Other Information

store at 20-25°C (68-77°F)

Inactive Ingredients

cocoa butter, corn starch, methylparaben, propylparaben

Additional Information

Distributed by: GSK Consumer Healthcare, Warren, NJ 07059

For most recent product information, visit www.preparationh.com

Trademarks are owned by or licensed to the GSK group of companies.

©2022 GSK group of companies or its licensor. Made in Germany

Individually quality sealed for your protection.

Do Not Use if foil imprinted “PREPARATION H” is torn or damaged.

Questions Or Comments?

Call weekdays 8 AM to 6 PM EST at

1-800-99PrepH or 1-800-997-7374

Principal Display Panel

PREPARATION H

HEMORRHOIDAL

SUPPOSITORIES

Phenylephrine HCl 0.25%

Provides Relief from Multiple Symptoms

  • Reduces Internal Hemorrhoidal Swelling
  • Prompt Relief from Itching & Discomfort
  • Also for Nighttime Relief

24 SUPPOSITORIES

000079891 – Front Carton

Stop Use and Ask A Doctor If
  • bleeding occurs
  • condition worsens or does not improve within 7 days
Ask A Doctor Before Use If You Have
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • difficulty in urination due to enlargement of the prostate gland
Ask A Doctor Or Pharmacist Before Use If You Are
  • presently taking a prescription drug for high blood pressure or depression

Structured Label Content

Uses
  • helps relieve the local itching and discomfort associated with hemorrhoids
  • temporarily shrinks hemorrhoidal tissue
  • temporarily reduces the swelling associated with irritation in hemorrhoids and other anorectal disorders
Purpose

Vasoconstrictor

Warnings

For rectal use only

Directions
  • adults: 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 this product.
  • detach one suppository from the strip; remove the foil wrapper before inserting into the rectum as follows:
    • hold suppository with the rounded end up
    • as shown, carefully separate foil tabs by inserting tip of fingernail at end marked “peel down”
    • slowly and evenly peel apart (do not tear) foil by pulling tabs down both sides, to expose the suppository
    • remove exposed suppository from the wrapper
    • insert one suppository into the rectum up to 4 times daily, especially at night, in the morning or after each bowel movement
  • children under 12 years of age: consult a doctor
Active Ingredient (Active ingredient)

Phenylephrine HCl 0.25%

Other Information (Other information)

store at 20-25°C (68-77°F)

Inactive Ingredients (Inactive ingredients)

cocoa butter, corn starch, methylparaben, propylparaben

Additional Information

Distributed by: GSK Consumer Healthcare, Warren, NJ 07059

For most recent product information, visit www.preparationh.com

Trademarks are owned by or licensed to the GSK group of companies.

©2022 GSK group of companies or its licensor. Made in Germany

Individually quality sealed for your protection.

Do Not Use if foil imprinted “PREPARATION H” is torn or damaged.

Questions Or Comments? (Questions or comments?)

Call weekdays 8 AM to 6 PM EST at

1-800-99PrepH or 1-800-997-7374

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

PREPARATION H

HEMORRHOIDAL

SUPPOSITORIES

Phenylephrine HCl 0.25%

Provides Relief from Multiple Symptoms

  • Reduces Internal Hemorrhoidal Swelling
  • Prompt Relief from Itching & Discomfort
  • Also for Nighttime Relief

24 SUPPOSITORIES

000079891 – Front Carton

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • bleeding occurs
  • condition worsens or does not improve within 7 days
Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • difficulty in urination due to enlargement of the prostate gland
Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)
  • presently taking a prescription drug for high blood pressure or depression

Advanced Ingredient Data


Raw Label Data

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