FDA Label for Preparation H

View Indications, Usage & Precautions

ACTIVE INGREDIENT (IN EACH SUPPOSITORY)
PURPOSE
USES
WARNINGS
ASK A DOCTOR BEFORE USE IF YOU HAVE
ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
WHEN USING THIS PRODUCT
STOP USE AND ASK A DOCTOR IF
IF PREGNANT OR BREAST FEEDING
KEEP OUT OF REACH OF CHILDREN
DIRECTIONS
OTHER INFORMATION
INACTIVE INGREDIENTS
QUESTIONS OR COMMENTS?
ADDITIONAL INFORMATION
PRINCIPAL DISPLAY PANEL

Preparation H Product Label

The following document was submitted to the FDA by the labeler of this product Haleon Us Holdings Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredient (In Each Suppository)

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

When Using This Product

do not exceed the recommended daily dosage unless directed by a doctor.

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 right away.

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
1-855-297-3031

Additional Information

Distributed by:

Haleon, Warren, NJ 07059

For most recent product information,

visit www.preparationh.com.

Trademarks are owned by or licensed

to the Haleon group of companies.

Active ingredient made in Japan

Individually quality sealed for your protection.

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

Principal Display Panel

HALEON

PREPARATION H
HEMORRHOIDAL
SUPPOSITORIES