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Leader Hemorrhoidal by Cardinal Health

Medically reviewed on January 17, 2017

Dosage form: suppository
Ingredients: COCOA BUTTER 2211mg, PHENYLEPHRINE HYDROCHLORIDE 6.5mg
Labeler: Cardinal Health
NDC Code: 70000-0223

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.

Cardinal Health Hemorrhoidal Suppositories Drug Facts

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

LEADER HEMORRHOIDAL 
cocoa butter, phenylephrine hcl suppository
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0223
Route of AdministrationRECTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
COCOA BUTTER (COCOA BUTTER) COCOA BUTTER2211 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE6.5 mg
Inactive Ingredients
Ingredient NameStrength
METHYLPARABEN 
PROPYLPARABEN 
STARCH, CORN 
Product Characteristics
ColorYELLOW (light) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:70000-0223-112 BLISTER PACK in 1 CARTON
11 SUPPOSITORY in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34601/17/2017
Labeler - Cardinal Health (097537435)

 
Cardinal Health

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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