Preparation H Suppository
FDA Label NDC 0573-2883

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 0573-2883). 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 ingredients, purposes, indications & usage, warnings, ask a doctor before use if you have, otc - ask doctor/pharmacist, otc - when using, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Active Ingredients

→ Purposes

→ Indications & Usage

→ Warnings

→ Ask A Doctor Before Use If You Have

→ Otc - Ask Doctor/pharmacist

→ Otc - When Using

→ Stop Use And Ask A Doctor If

→ Otc - Pregnancy Or Breast Feeding

→ Otc - Keep Out Of Reach Of Children

→ Directions

→ Other Information

→ Inactive Ingredients

→ Questions Or Comments?

→ Principal Display Panel

Active Ingredients

Cocoa butter 88.44%

Phenylephrine HCl 0.25%

Purposes

Protectant

Vasoconstrictor

Indications & 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

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

Otc - Ask Doctor/Pharmacist

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

Otc - When Using

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

Otc - Pregnancy Or Breast Feeding

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

Otc - 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.

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