FDA.reportPublic FDA data

rugby hemorrhoidal

Manufacturer
Rugby Laboratories
Effective date
2024-10-22
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:28:37

Label at a glance#

Productrugby hemorrhoidal
Active ingredientCOCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE
Label structure8 sections

Indications and 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

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 rounded end up • see illustrations: carefully separate foil tabs by insert...

Label contents#

Full prescribing information#

Active ingredients (in each suppository)

OTC - ACTIVE INGREDIENT SECTION

Cocoa butter 88.44%

Phenylephrine HCl 0.25%

Purposes

OTC - PURPOSE SECTION

Protectant

Vasoconstrictor

Uses

INDICATIONS & USAGE SECTION

  • 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

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.

When using this product

OTC - WHEN USING SECTION

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

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,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

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 rounded end up
  • see illustrations: 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

STORAGE AND HANDLING SECTION

  • store at 20-25°C (68-77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

methylparaben, propylparaben, topical starch

Questions or comments?

OTC - QUESTIONS SECTION

1-800-645-2158

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to the active ingredients of Preparation H® Hemorrhoidal Suppositories

Easy Open

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

hemorrhoidal-suppositories-image
hemorrhoidal-suppositories-image

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
0536-1186-12rugby hemorrhoidal1 in 1 BLISTER PACKSUPPOSITORY12
0536-1186-12rugby hemorrhoidal12 in 1 CARTONSUPPOSITORY122

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0536-1186RUGBY HEMORRHOIDAL (COCOA BUTTER, PHENYLEPHRINE HCL) SUPPOSITORY [RUGBY LABORATORIES]2Current NDC, Legacy NDC, 2 package rows20241024_c1a126b5-0d34-437f-a7ef-8d5cbeb7b03b.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0536-1186-12EA - Each0536-11863d922005-0bbd-4064-9fa3-82d80ed519c212018-12-13

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0536-11860536-1186-12

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 BUTTER512OYT1CRRACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
METHYLPARABENA2I8C7HI9TIACT
PROPYLPARABENZ8IX2SC1OHIACT
STARCH, CORNO8232NY3SJIACT

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
rugby hemorrhoidalCOCOA BUTTER, PHENYLEPHRINE HCLRugby Laboratoriesc1a126b5-0d34-437f-a7ef-8d5cbeb7b03b2024-10-22WarningsExact identifier
ndc (package): 0536-1186-12
ndc (product): 0536-1186
ndc11 (package): 00536118612
spl id: 8abe2b3e-bfd7-4f76-9aa1-5eb375146909
spl set id: c1a126b5-0d34-437f-a7ef-8d5cbeb7b03b

Reported adverse events (FAERS/openFDA)#

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