Gnp Hemmorrhoidal Suppositories

Gnp Hemmorrhoidal Suppositories
SPL v2
SPL
SPL Set ID 231a850a-bad6-9a30-e063-6394a90a0fdc
Route
RECTAL
Published
Effective Date 2024-10-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Cocoa Butter (2.39 g) Phenylephrine (6.75 mg)
Inactive Ingredients
Starch, Corn Methylparaben Propylparaben

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-10-15

Description

Cocoa butter 88.44% Phenylephrine hydrochloride 0.25%

Purpose

Protectant Vasoconstrictor


Medication Information

Purpose

Protectant

Vasoconstrictor

Description

Cocoa butter 88.44% Phenylephrine hydrochloride 0.25%

Uses
  • temporarily shrinks hemorrhoidal tissue
  • gives temporary relief to the itching, burning and discomfort associated with hemorrhoids
  • aids in protecting irritated anorectal areas
Section 51945-4

The product package shown below represents a sample of that currently in use. Additional packaging may also be available.

GNP Hemorrhoidal Suppositories 12ct

Distributed Amerisource Bergen

1 West First Avenue

Conshohocken, PA 19428

785PVHemSupp.jpg

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 soft cloth before insertion of this product.
  • Detach one suppository from the strip; remove plastic wrapper before inserting into the rectum as follows:

  • hold suppository with rounded end up
  • as shown, carefully separate plastic tabs by inserting tip of finger nail at end marked "peep here"
  • slowly and evenly peel apart (do not tear) plastic by pulling tabs down both sides, to expose the suppository
  • remove exposed suppository from wrapper
  • insert on suppository into the rectum up to 4 times daily, especially at night, in the morning or after each bowl movement

  • children under 12 years of age ask a doctor
Other Information

store at 20-25°C (68-77ºF)

Inactive Ingredients

corn starch, methylparaben, propylparaben

Questions Or Comments?

1-800-492-5988

When Using This Product
  • do not exceed the recommended daily dosage unless directed by a doctor
  • in case of bleeding or if condition worsens or does not improve within 7 days, consult a doctor promptly
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

Ask A Doctor Before Use If You Have
  • heart disease
  • thyroid disease
  • difficulty in urination due to enlargement of the prostate gland
  • high blood pressure
  • diabetes
Active Ingredients (per Suppository)

Cocoa butter 88.44%

Phenylephrine hydrochloride 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
  • temporarily shrinks hemorrhoidal tissue
  • gives temporary relief to the itching, burning and discomfort associated with hemorrhoids
  • aids in protecting irritated anorectal areas
Section 51945-4 (51945-4)

The product package shown below represents a sample of that currently in use. Additional packaging may also be available.

GNP Hemorrhoidal Suppositories 12ct

Distributed Amerisource Bergen

1 West First Avenue

Conshohocken, PA 19428

785PVHemSupp.jpg

Purpose

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 soft cloth before insertion of this product.
  • Detach one suppository from the strip; remove plastic wrapper before inserting into the rectum as follows:

  • hold suppository with rounded end up
  • as shown, carefully separate plastic tabs by inserting tip of finger nail at end marked "peep here"
  • slowly and evenly peel apart (do not tear) plastic by pulling tabs down both sides, to expose the suppository
  • remove exposed suppository from wrapper
  • insert on suppository into the rectum up to 4 times daily, especially at night, in the morning or after each bowl movement

  • children under 12 years of age ask a doctor
Other Information (Other information)

store at 20-25°C (68-77ºF)

Inactive Ingredients (Inactive ingredients)

corn starch, methylparaben, propylparaben

Questions Or Comments? (Questions or comments?)

1-800-492-5988

When Using This Product (When using this product)
  • do not exceed the recommended daily dosage unless directed by a doctor
  • in case of bleeding or if condition worsens or does not improve within 7 days, consult a doctor promptly
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

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • heart disease
  • thyroid disease
  • difficulty in urination due to enlargement of the prostate gland
  • high blood pressure
  • diabetes
Active Ingredients (per Suppository) (Active Ingredients (per suppository))

Cocoa butter 88.44%

Phenylephrine hydrochloride 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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