LEADER HEMORRHOIDAL- cocoa butter, phenylephrine hcl suppository

Leader Hemorrhoidal by

Drug Labeling and Warnings

Leader Hemorrhoidal by is a Otc medication manufactured, distributed, or labeled by Cardinal Health. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients (in each suppository)

Cocoa butter 88.44%

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. (1-800-222-1222)

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

Package/Label Principal Display Panel

Hemorrhoidal Suppositories

Reduces Internal Swelling

Soothes and Protects

Prompt Soothing Relief From Painful Burning, Itching and Discomfort

For Nighttime Relief

12 SUPPOSITORIES

COMPARE TO PREPARATION H®

active ingredients

100% Money Back Guarantee

INGREDIENTS AND APPEARANCE

LEADER HEMORRHOIDAL 
cocoa butter, phenylephrine hcl suppository

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70000-0223
Route of Administration	RECTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
COCOA BUTTER (UNII: 512OYT1CRR) (COCOA BUTTER - UNII:512OYT1CRR)	COCOA BUTTER	2211 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	6.5 mg

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

Product Characteristics
Color	YELLOW (light)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70000-0223-1	12 in 1 CARTON	01/17/2017
1		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 final	part346	01/17/2017

Labeler - Cardinal Health (097537435)