FDA.reportPublic FDA data

PREPARATION H

Manufacturer
Haleon US Holdings LLC
Effective date
2025-04-18
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:59:21

Label at a glance#

ProductPREPARATION H
Active ingredientPHENYLEPHRINE HYDROCHLORIDE
Label structure10 sections

Indications and 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

Dosage and administration

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 fi...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Phenylephrine HCl 0.25%

Purpose

OTC - PURPOSE SECTION

Vasoconstrictor

Uses

INDICATIONS & USAGE SECTION

  • 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

WARNINGS SECTION

For rectal use only

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • 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

OTC - ASK DOCTOR/PHARMACIST SECTION

  • presently taking a prescription drug for high blood pressure or depression

Stop use and ask a doctor if

OTC - STOP USE SECTION

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

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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
Directions Opening Guide 01
Directions Opening Guide 01
Directions Opening Guide 02
Directions Opening Guide 02

Other information

OTHER SAFETY INFORMATION

store at 20-25°C (68-77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

cocoa butter, corn starch, methylparaben, propylparaben

Questions or comments?

OTC - QUESTIONS SECTION

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

Additional Information

SPL UNCLASSIFIED SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

24 SUPPOSITORIES

000079891 – Front Carton

PreparationH Hemorrhoidal Suppositories 24 count.jpg
PreparationH Hemorrhoidal Suppositories 24 count.jpg

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
PHENYLEPHRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0573-1378-00PREPARATION H1 in 1 BLISTER PACKSUPPOSITORY14
0573-1378-00PREPARATION H48 in 1 CARTONSUPPOSITORY484
0573-1378-01PREPARATION H12 in 1 CARTONSUPPOSITORY124
0573-1378-01PREPARATION H1 in 1 BLISTER PACKSUPPOSITORY14
0573-1378-06PREPARATION H1 in 1 BLISTER PACKSUPPOSITORY14
0573-1378-06PREPARATION H24 in 1 CARTONSUPPOSITORY244

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0573-1378PREPARATION H (PHENYLEPHRINE HYDROCHLORIDE) SUPPOSITORY [HALEON US HOLDINGS LLC]4Current NDC, 6 package rows20250419_96d2e0e7-2de0-4660-9ffd-9edb2ad224d8.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0573-1378-00EA - Each0573-1378a8776a44-944e-4668-9169-9288f451c66e12024-12-10
0573-1378-01EA - Each0573-137812ac2524-db6f-4fae-ac59-584f8857237c12024-01-04
0573-1378-06EA - Each0573-13786313f717-73c4-416a-82ee-18da6e92445d12024-09-09

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0573-13780573-1378-01, 0573-1378-06, 0573-1378-00

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
COCOA BUTTER512OYT1CRRIACT
STARCH, CORNO8232NY3SJIACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLPARABENZ8IX2SC1OHIACT
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PREPARATION HPHENYLEPHRINE HYDROCHLORIDEHaleon US Holdings LLC96d2e0e7-2de0-4660-9ffd-9edb2ad224d82025-04-18WarningsExact identifier
ndc (package): 0573-1378-00
ndc (package): 0573-1378-06
ndc (package): 0573-1378-01
ndc (product): 0573-1378
ndc11 (package): 00573137800
ndc11 (package): 00573137806
ndc11 (package): 00573137801
spl id: 331041bf-cde7-dceb-e063-6394a90a65e0
spl set id: 96d2e0e7-2de0-4660-9ffd-9edb2ad224d8

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.