Drug Facts

Drug Facts

SPL v2

SPL

SPL Set ID 40fde50a-3cc0-4286-9b33-8f3912254c33

Route

RECTAL

Published

Effective Date 2025-04-10

Document Type 34390-5 HUMAN OTC DRUG LABEL

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: 42 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2025-04-30

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

Other Information

store at 20-25°C (68-77°F)

Inactive Ingredients

cocoa butter, corn starch, methylparaben, propylparaben

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.

Questions Or Comments?

Call weekdays 8 AM to 6 PM EST at

1-855-297-3031

Principal Display Panel

HALEON

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

12 SUPPOSITORIES

216802 – Front Carton

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.

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

Active Ingredient (in Each Suppository)

Phenylephrine HCl 0.25%

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

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:

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.

Questions Or Comments? (Questions or comments?)

Call weekdays 8 AM to 6 PM EST at

1-855-297-3031

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

HALEON

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

12 SUPPOSITORIES

216802 – Front Carton

When Using This Product (When using this product)

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

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

If Pregnant Or Breast Feeding (If pregnant or breast feeding)

ask a health professional before use.

Keep Out of Reach of Children (Keep out of reach of children)

If swallowed, get medical help or contact a Poison Control Center right away.

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

Active Ingredient (in Each Suppository) (Active ingredient (in each suppository))

Phenylephrine HCl 0.25%

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

[{"name": "COCOA BUTTER", "unii": "512OYT1CRR", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STARCH, CORN", "unii": "O8232NY3SJ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "METHYLPARABEN", "unii": "A2I8C7HI9T", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLPARABEN", "unii": "Z8IX2SC1OH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PHENYLEPHRINE", "unii": "1WS297W6MV", "classCode": "ACTIB", "strengthNumerator": "6.25", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}]

Raw Label Data

All Sections (JSON)

{"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", "Other information": "store at 20-25°C (68-77°F)", "Inactive ingredients": "cocoa butter, corn starch, methylparaben, propylparaben", "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. ©2025 Haleon group of companies or its licensor. Active ingredient made in Japan 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 1-855-297-3031", "PRINCIPAL DISPLAY PANEL": "HALEON 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 12 SUPPOSITORIES 216802 – Front Carton", "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.", "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", "Active ingredient (in each suppository)": "Phenylephrine HCl 0.25%", "Ask a doctor or pharmacist before use if you are": "presently taking a prescription drug for high blood pressure or depression"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:45.772076 · Updated: 2026-03-14T23:11:32.027299