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  5. Label Information: Leader Hemorrhoidal

FDA Label for Leader Hemorrhoidal

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. IF PREGNANT OR BREAST FEEDING
    6. KEEP OUT OF REACH OF CHILDREN
    7. DIRECTIONS
    8. OTHER INFORMATION
    9. INACTIVE INGREDIENT
    10. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Leader Hemorrhoidal Product Label

The following document was submitted to the FDA by the labeler of this product Cardinal Health, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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

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