PREPARATION H- phenylephrine hydrochloride suppository

PREPARATION H by

Drug Labeling and Warnings

PREPARATION H by is a Otc medication manufactured, distributed, or labeled by Consumer Healthcare Holdings (US) LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Phenylephrine HCl 0.25%

Purpose

Vasoconstrictor

Uses

• helps relieve the local itching and discomfort associated with hemorrhoids
• temporarily shrinks hemorrhoidal tissue
• temporarily reduces the swelling associated with irritation in hemorrhoids and other anorectal disorders

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 the 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

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.

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 the rounded end up
  • as shown, 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 the 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: consult a doctor

Other information

store at 20-25°C (68-77°F)

Inactive ingredients

cocoa butter, corn starch, methylparaben, propylparaben

Questions or comments?

Call weekdays 8 AM to 6 PM EST at
1-800-99PrepH or 1-800-997-7374

Additional Information

Distributed by: GSK Consumer Healthcare, Warren, NJ 07059
For most recent product information, visit www.preparationh.com
Trademarks are owned by or licensed to the GSK group of companies.
©2022 GSK group of companies or its licensor. Made in Germany

Individually quality sealed for your protection.

Do Not Use if foil imprinted “PREPARATION H” is torn or damaged.

PRINCIPAL DISPLAY PANEL

PREPARATION H
HEMORRHOIDAL
SUPPOSITORIES

Phenylephrine HCl 0.25%

Prevents Further Irritation

• Reduces Internal Hemorrhoidal Swelling
• Prompt Relief from Itching & Discomfort
• Also for Nighttime Relief

12 SUPPOSITORIES

000079890 – Front Carton

INGREDIENTS AND APPEARANCE

PREPARATION H 
phenylephrine hydrochloride suppository

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0573-1378
Route of Administration	RECTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	6.25 mg

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

Product Characteristics
Color	yellow (Light yellow)	Score	no score
Shape	BULLET (Bullet shaped suppository)	Size	32mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0573-1378-01	12 in 1 CARTON	12/16/2022
1		1 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 0573-1378-06	24 in 1 CARTON	12/16/2022
2		1 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC: 0573-1378-00	48 in 1 CARTON	12/16/2022
3		1 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	12/16/2022

Labeler - Haleon US Holdings LLC (079944263)