Perrigo Company Hemorrhoidal Suppositories Drug Facts

Perrigo Company Hemorrhoidal Suppositories Drug Facts
SPL v3
SPL
SPL Set ID 8155ed74-9412-498f-998c-4a29c46e934f
Route
RECTAL
Published
Effective Date 2024-10-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Cocoa Butter (2211 mg) Phenylephrine (6.5 mg)
Inactive Ingredients
Methylparaben Propylparaben Starch, Corn

Identifiers & Packaging

Pill Appearance
Color: yellow
Marketing Status
OTC MONOGRAPH DRUG Active Since 2016-05-05

Description

Cocoa butter 88.44% Phenylephrine HCl 0.25%

Purpose

Protectant Vasoconstrictor


Medication Information

Purpose

Protectant Vasoconstrictor

Description

Cocoa butter 88.44% Phenylephrine HCl 0.25%

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
Purposes

Protectant

Vasoconstrictor

Warnings

For rectal use only

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 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
  • store at 20-25°C (68-77°F)
Inactive Ingredients

methylparaben, propylparaben, topical starch

Questions Or Comments?

1-800-719-9260

When Using This Product

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

Stop Use and Ask A 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 the prostate gland
Package/label Principal Display Panel

Compare to the active ingredients of Preparation H® Hemorrhoidal Suppositories

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

E-Z Open Wrapper

24 SUPPOSITORIES

Active Ingredients (in Each Suppository)

Cocoa butter 88.44%

Phenylephrine HCl 0.25%

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
Purposes

Protectant

Vasoconstrictor

Warnings

For rectal use only

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 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 (Other information)
  • store at 20-25°C (68-77°F)
Inactive Ingredients (Inactive ingredients)

methylparaben, propylparaben, topical starch

Questions Or Comments? (Questions or comments?)

1-800-719-9260

When Using This Product (When using this product)

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

Stop Use and Ask A Doctor If (Stop use and ask a 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 the prostate gland
Package/label Principal Display Panel (Package/Label Principal Display Panel)

Compare to the active ingredients of Preparation H® Hemorrhoidal Suppositories

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

E-Z Open Wrapper

24 SUPPOSITORIES

Active Ingredients (in Each Suppository) (Active ingredients (in each suppository))

Cocoa butter 88.44%

Phenylephrine HCl 0.25%

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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