Preparation H Suppositories(cocoa butter and phenylephrine HCl)

Major Prep Hemorrhoidal by

Drug Labeling and Warnings

Major Prep Hemorrhoidal by is a Otc medication manufactured, distributed, or labeled by Major Pharmaceuticals. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

MAJOR PREP HEMORRHOIDAL- hard fat, phenylephrine hcl suppository 
Major Pharmaceuticals

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Preparation H Suppositories
(cocoa butter and phenylephrine HCl)

DRUG FACTS

ACTIVE INGREDIENTS

Hard Fat 85.5%

Phenylephrine HCl 0.25%

PURPOSES

Protectant

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 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 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 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

cod liver oil, corn starch, methylparaben, propylparaben

QUESTIONS OR COMMENTS?

Call (800) 616-2471

PRODUCT PACKAGING

MAJOR-PREP 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

24 SUPPOSITORIES

Individually sealed for your protection.

Do Not Use if foil is torn or open.

Distributed by
Major Pharmaceuticals
Livonia, MI 48150  USA

MAJOR PREP HEMORRHOIDAL 
hard fat, phenylephrine hcl suppository

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0904-5304
Route of Administration	RECTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	74 mg  in 2.5 g
FAT, HARD (UNII: 8334LX7S21) (FAT, HARD - UNII:8334LX7S21)	FAT, HARD	2 g  in 2.5 g

Inactive Ingredients
Ingredient Name	Strength
STARCH, CORN (UNII: O8232NY3SJ)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
COD LIVER OIL (UNII: BBL281NWFG)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0904-5304-24	24 in 1 CARTON	03/28/2008	09/23/2018
1		24 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 final	part346	03/28/2008	09/23/2018

Labeler - Major Pharmaceuticals (191427277)

Revised: 1/2020

Document Id: ed4e822e-03a4-40e8-baf7-91e75a873320

34390-5

Set id: d47f9fa8-af7b-46c5-af27-3fa1eb5e26da

Version: 4

Effective Time: 20200102