Preparation H Suppository
FDA Label NDC 0573-1378

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Haleon Us Holdings Llc for the product Preparation H (NDC 0573-1378). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, stop use and ask a doctor if, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Phenylephrine HCl 0.25%

Purpose

Vasoconstrictor

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

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

Stop Use And Ask A Doctor If

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

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

Other Information

store at 20-25°C (68-77°F)

Inactive Ingredients

cocoa butter, corn starch, methylparaben, propylparaben

Questions Or Comments?

Call weekdays 8 AM to 6 PM EST at
1-800-99PrepH or 1-800-997-7374

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.

Principal Display Panel

PREPARATION H
HEMORRHOIDAL
SUPPOSITORIES

Phenylephrine HCl 0.25%

Prevents Further Irritation

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

    • 12 SUPPOSITORIES

    000079890 – Front Carton

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