Phenylephrine Hemorrhoidal Foil Wrapped Suppositories

Phenylephrine Hemorrhoidal Foil Wrapped Suppositories
SPL v2
SPL
SPL Set ID 35ccb320-e902-3d1a-e063-6294a90a68d5
Route
RECTAL
Published
Effective Date 2025-05-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Phenylephrine (5 mg)
Inactive Ingredients
Cocoa Butter Propylparaben Starch, Corn Methylparaben

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-05-23

Description

Active ingredient Purpose (in each suppository) Phenylephrine Hydrochloride 0.25% ........................... Vasoconstrictor

Purpose

Purpose - Vasoconstrictor


Medication Information

Purpose

Purpose - Vasoconstrictor

Description

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

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.

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.

Drug Facts:

Active ingredient Purpose

(in each suppository)

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

Package Label

Package Label

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

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)

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.


Structured Label Content

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
Purpose

Purpose - Vasoconstrictor

Warnings

For rectal use only

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.

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.

Drug Facts:

Active ingredient Purpose

(in each suppository)

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

Package Label

Package Label

Other Information: (Other information:)

• Store at 20° - 25°C (68° - 77°F)

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

Inactive Ingredients: (Inactive ingredients:)

Cocoa butter, methylparaben, propylparaben, topical starch

When Using This Product: (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 (Stop use and ask doctor if)

• Bleeding occurs • Condition worsens or does not improve within 7 days

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

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. (1-800-222-1222)

Ask A Doctor Before Use If You Have (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 (Ask a doctor or pharmacist before use if you are)

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


Advanced Ingredient Data


Raw Label Data

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