PHENYLEPHRINE HEMORRHOIDAL- hemorrhoidal suppositories suppository

Phenylephrine Hemorrhoidal by

Drug Labeling and Warnings

Phenylephrine Hemorrhoidal by is a Otc medication manufactured, distributed, or labeled by Neilmed Pharmaceuticals Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts:

Active ingredient Purpose

(in each suppository)

Phenylephrine Hydrochloride 0.25% ........................... Vasoconstrictor

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 prostate gland

Ask a doctor or pharmacist before use if you are

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

When using this product:

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

Bleeding occurs Condition worsens or does not improve within 7 days

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

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

Other information:

Store at 20° - 25°C (68° - 77°F)

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

Inactive ingredients:

Cocoa butter, methylparaben, propylparaben, topical starch

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 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.

Questions or comments? 1(877) 477-8633

Important:

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

Purpose - Vasoconstrictor

Package Label

Package Label

INGREDIENTS AND APPEARANCE

PHENYLEPHRINE HEMORRHOIDAL 
hemorrhoidal suppositories suppository

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13709-330
Route of Administration	RECTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg  in 2 g

Inactive Ingredients
Ingredient Name	Strength
COCOA BUTTER (UNII: 512OYT1CRR)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
STARCH, CORN (UNII: O8232NY3SJ)
METHYLPARABEN (UNII: A2I8C7HI9T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13709-330-01	30 in 1 CARTON	05/23/2025
1		2 g in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 13709-330-02	15 in 1 CARTON	05/23/2025
2		2 g in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M015	05/23/2025

Labeler - Neilmed Pharmaceuticals Inc. (799295915)

Establishment
Name	Address	ID/FEI	Business Operations
Neilmed Pharmaceuticals Inc.		799295915	manufacture(13709-330)