Drug Facts

Drug Facts

SPL v18

SPL

SPL Set ID a23ded81-78ba-c199-a8f0-aaf360b216ff

Route

RECTAL

Published

Effective Date 2020-11-12

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Cocoa Butter (2211 mg) Phenylephrine (6.25 mg)

Inactive Ingredients

Starch, Corn Methylparaben Propylparaben

Identifiers & Packaging

Pill Appearance

Shape: bullet Color: yellow Size: 150 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Completed Since 2004-01-05 Until 2024-10-31

Description

Cocoa butter 88.44% Phenylephrine HCl 0.25%

Purpose

Protectant Vasoconstrictor

Medication Information

Indications and Usage

Uses

helps relieve the local itching and discomfort associated with hemorrhoids
temporarily relieves burning and shrinks hemorrhoidal tissue
temporarily provides a coating for relief of anorectal discomforts
temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful

Purpose

Protectant Vasoconstrictor

Description

Cocoa butter 88.44% Phenylephrine HCl 0.25%

Section 50565-1

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

Section 50567-7

When using this productdo not exceed the recommended daily dosage unless directed by a doctor

Section 50568-5

Ask a doctor or pharmacist before use if you arepresently taking a prescription drug for high blood pressure or depression.

Section 53414-9

If pregnant or breast-feeding,ask a health professional before use.

Purposes

Protectant

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 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 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: ask a doctor

Other Information

store at 20-25°C (68-77°F)

Active Ingredients

Cocoa butter 88.44%

Phenylephrine HCl 0.25%

Inactive Ingredients

corn starch, methylparaben, propylparaben

Questions Or Comments?

Call weekdays 9 AM to 5 PM EST at 1-800-99PrepH or 1-800-997-7374

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

Pfizer, Madison, NJ 07940 USA © 2011 Pfizer Inc.

Principal Display Panel

NDC 0573-2883-10

PREPARATION H ^®

HEMORRHOIDAL SUPPOSITORIES

Reduces Internal Swelling, Soothes and Protects

Prompt Soothing Relief from Painful Burning, Itching and Discomfort
Shrinks Swollen Hemorrhoidal Tissue
Protects Irritated Tissue
Also for Nighttime Relief

12 SUPPOSITORIES

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

Structured Label Content

Indications and Usage (34067-9)

Uses

helps relieve the local itching and discomfort associated with hemorrhoids
temporarily relieves burning and shrinks hemorrhoidal tissue
temporarily provides a coating for relief of anorectal discomforts
temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful

Section 50565-1 (50565-1)

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

Section 50567-7 (50567-7)

When using this productdo not exceed the recommended daily dosage unless directed by a doctor

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you arepresently taking a prescription drug for high blood pressure or depression.

Section 53414-9 (53414-9)

If pregnant or breast-feeding,ask a health professional before use.

Purposes

Protectant

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 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 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: ask a doctor

Other Information (Other information)

store at 20-25°C (68-77°F)

Active Ingredients

Cocoa butter 88.44%

Phenylephrine HCl 0.25%

Inactive Ingredients (Inactive ingredients)

corn starch, methylparaben, propylparaben

Questions Or Comments? (Questions or comments?)

Call weekdays 9 AM to 5 PM EST at 1-800-99PrepH or 1-800-997-7374

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC 0573-2883-10

PREPARATION H ^®

HEMORRHOIDAL SUPPOSITORIES

Reduces Internal Swelling, Soothes and Protects

Prompt Soothing Relief from Painful Burning, Itching and Discomfort
Shrinks Swollen Hemorrhoidal Tissue
Protects Irritated Tissue
Also for Nighttime Relief

12 SUPPOSITORIES

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

Advanced Ingredient Data

[{"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": "COCOA BUTTER", "unii": "512OYT1CRR", "classCode": "ACTIB", "strengthNumerator": "2211", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "PHENYLEPHRINE", "unii": "1WS297W6MV", "classCode": "ACTIB", "strengthNumerator": "6.25", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"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": "COCOA BUTTER", "unii": "512OYT1CRR", "classCode": "ACTIB", "strengthNumerator": "2211", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "PHENYLEPHRINE", "unii": "1WS297W6MV", "classCode": "ACTIB", "strengthNumerator": "6.25", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Uses helps relieve the local itching and discomfort associated with hemorrhoids temporarily relieves burning and shrinks hemorrhoidal tissue temporarily provides a coating for relief of anorectal discomforts temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful", "50565-1": "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.", "50567-7": "When using this product do not exceed the recommended daily dosage unless directed by a doctor", "50568-5": "Ask a doctor or pharmacist before use if you are presently taking a prescription drug for high blood pressure or depression.", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "Purposes": "Protectant 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 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 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: ask a doctor", "Other information": "store at 20-25°C (68-77°F)", "Active Ingredients": "Cocoa butter 88.44% Phenylephrine HCl 0.25%", "Inactive ingredients": "corn starch, methylparaben, propylparaben", "Questions or comments?": "Call weekdays 9 AM to 5 PM EST at 1-800-99PrepH or 1-800-997-7374 For most recent product information, visit www.preparationh.com Pfizer, Madison, NJ 07940 USA © 2011 Pfizer Inc.", "PRINCIPAL DISPLAY PANEL": "NDC 0573-2883-10 PREPARATION H ® HEMORRHOIDAL SUPPOSITORIES Reduces Internal Swelling, Soothes and Protects Prompt Soothing Relief from Painful Burning, Itching and Discomfort Shrinks Swollen Hemorrhoidal Tissue Protects Irritated Tissue Also for Nighttime Relief 12 SUPPOSITORIES", "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"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:49.843822 · Updated: 2026-03-14T23:02:36.495120