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LEADER HEMORRHOIDAL by CARDINAL HEALTH, INC.

Dosage form: suppository
Ingredients: Phenylephrine Hydrochloride 5.77mg, Fat, Hard 1881mg
Labeler: CARDINAL HEALTH, INC.
NDC Code: 37205-715

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.

Hemorrhoidal Suppositories

ACTIVE INGREDIENT

Hard Fat 85.5%
Phenylephrine HCl 0.25%

PURPOSE

● 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 an enlarged prostate

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 use more than directed

Stop use and ask a doctor if
• symptoms get worse or do not get better in 7 days
• bleeding occurs

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, clean the affected area by patting or blotting with an appropriate cleansing wipe. Gently dry by patting or blotting with tissue or a soft cloth before insertion of the product.
• detach 1 suppository from the strip; remove wrapper before inserting into the rectum as follows:

                 
                  • hold suppository with pointed end up
                  • carefully separate tabs with fingernail
                  • slowly pull apart by pulling tabs down on both sides
                  • remove 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: ask a doctor

OTHER INFORMATION

• store at 20-25˚C (68-77˚F)

INACTIVE INGREDIENT

cod liver oil, corn starch, methylparaben, propylparaben

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 37205-715-16

Compare to Preparation H® active ingredients

LEADER HEMORRHOIDAL SUPPOSITORIES
Prompt Relief
For Temporary Relief From Pain and Itching of Hemorrhoids
12 ADULT SUPPOSITORIES

Satisfaction Guaranteed

LEADER HEMORRHOIDAL  
phenylephrine hydrochloride, hard fat suppository
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37205-715
Route of AdministrationRECTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Phenylephrine Hydrochloride (Phenylephrine) Phenylephrine Hydrochloride5.77 mg
Fat, Hard (Fat, Hard) Fat, Hard1881 mg
Inactive Ingredients
Ingredient NameStrength
Cod Liver Oil 
Starch, Corn 
Methylparaben 
Propylparaben 
Packaging
#Item CodePackage Description
1NDC:37205-715-1612 SUPPOSITORY (SUPPOSITORY) in 1 CARTON
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34603/12/2009
Labeler - CARDINAL HEALTH, INC. (097537435)
Registrant - G&W Laboratories, Inc. (001271188)
Establishment
NameAddressID/FEIOperations
G&W Laboratories, Inc.001271188MANUFACTURE

Revised: 01/2012
 
CARDINAL HEALTH, INC.

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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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