Phenylephrine Hemorrhoidal

Manufacturer
Neilmed Pharmaceuticals Inc.
Effective date
2025-06-20
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:03:34

Label at a glance#

ProductPhenylephrine Hemorrhoidal
Active ingredientPHENYLEPHRINE HYDROCHLORIDE
Label structure15 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 as shown in the illustration • Insert one suppository into the rectum pointed end first, up to 4 times daily, especially at night, in the morni...

Storage and handling

• Store at 20° - 25°C (68° - 77°F) • Lot No. & Exp. Date: see wrapper or box

Label contents#

Full prescribing information#

Drug Facts:

OTC - ACTIVE INGREDIENT SECTION

Active ingredient Purpose

(in each suppository)

Phenylephrine Hydrochloride 0.25% ........................... 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 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 • Children under 12 years of age: ask a doctor

Stop use and ask 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)

Other information:

STORAGE AND HANDLING SECTION

• Store at 20° - 25°C (68° - 77°F)

• Lot No. & Exp. Date: see wrapper or box

Inactive ingredients:

INACTIVE INGREDIENT SECTION

Cocoa butter, methylparaben, propylparaben, topical starch

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 as shown in the illustration • Insert one suppository into the rectum pointed end first, up to 4 times daily, especially at night, in the morning or after each bowel movement.

Important:

SAFE HANDLING WARNING SECTION

Please do not discard this printed box and any enclosed printed material. The inside final product may not have all the details you require for the ongoing use of the product.

Purpose

OTC - PURPOSE SECTION

Purpose - Vasoconstrictor

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Phenylephrine 15ctPhenylephrine 15ctPhenylephrine suppositoriesPhenylephrine suppositoriesPackage Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2715398phenylephrine hydrochloride 0.25 % Rectal SuppositoryPSN2
2715398phenylephrine hydrochloride 0.0025 MG/MG Rectal SuppositorySCD2
2715398phenylephrine hydrochloride 0.25 % Rectal SuppositorySY2

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
13709-330-01Phenylephrine Hemorrhoidal2 g in 1 BLISTER PACKSUPPOSITORY22
13709-330-01Phenylephrine Hemorrhoidal30 in 1 CARTONSUPPOSITORY302
13709-330-02Phenylephrine Hemorrhoidal2 g in 1 BLISTER PACKSUPPOSITORY22
13709-330-02Phenylephrine Hemorrhoidal15 in 1 CARTONSUPPOSITORY152

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
13709-33013709-330-01, 13709-330-02

Ingredients#

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

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

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
Phenylephrine HemorrhoidalHEMORRHOIDAL SUPPOSITORIESNeilmed Pharmaceuticals Inc.35ccb320-e902-3d1a-e063-6294a90a68d52025-06-20WarningsExact identifier
ndc (package): 13709-330-01
ndc (package): 13709-330-02
ndc (product): 13709-330
ndc11 (package): 13709033002
ndc11 (package): 13709033001
spl id: 38058834-a45a-59b7-e063-6294a90ad2aa
spl set id: 35ccb320-e902-3d1a-e063-6294a90a68d5

Reported adverse events (FAERS/openFDA)#

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