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  5. Label Information: Preparation H

FDA Label for Preparation H

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS
    2. PURPOSES
    3. INDICATIONS & USAGE
    4. WARNINGS
    5. ASK A DOCTOR BEFORE USE IF YOU HAVE
    6. OTC - ASK DOCTOR/PHARMACIST
    7. OTC - WHEN USING
    8. STOP USE AND ASK A DOCTOR IF
    9. OTC - PREGNANCY OR BREAST FEEDING
    10. OTC - KEEP OUT OF REACH OF CHILDREN
    11. DIRECTIONS
    12. OTHER INFORMATION
    13. INACTIVE INGREDIENTS
    14. QUESTIONS OR COMMENTS?
    15. PRINCIPAL DISPLAY PANEL

Preparation H Product Label

The following document was submitted to the FDA by the labeler of this product Haleon Us Holdings Llc. 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 Ingredients



Cocoa butter 88.44%

Phenylephrine HCl 0.25%


Purposes



Protectant

Vasoconstrictor


Indications & Usage



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

Otc - Ask Doctor/Pharmacist



Ask a doctor or pharmacist before use if you are presently taking a prescription drug for high blood pressure or depression.


Otc - When Using



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

Otc - Pregnancy Or Breast Feeding



If pregnant or breast-feeding, ask a health professional before use.


Otc - Keep Out Of Reach Of Children



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
    ••••••••
    Figure - preparation 01

    Figure - preparation 01



    Other Information



    store at 20-25°C (68-77°F)


    Inactive Ingredients



    corn starch, methylparaben, propylparaben


    Questions Or Comments?



    Call weekdays 9 AM to 5 PM EST at 1-800-99PrepH or 1-800-997-7374

    For most recent product information, visit www.preparationh.com
    Pfizer, Madison, NJ 07940 USA © 2011 Pfizer Inc.


    Principal Display Panel



    NDC 0573-2883-10

    PREPARATION H®

    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

      • 12 SUPPOSITORIES

      Principal Display Panel - 12 Suppository Blister Pack Carton - preparation 04

      Principal Display Panel - 12 Suppository Blister Pack Carton - preparation 04

      NDC 0573-2880-31

      PREPARATION H®
      HEMORRHOIDAL
      SUPPOSITORIES

      Provides Relief from
      MULTIPLE SYMPTOMS

      • •Reduces Internal Swelling,
        Soothes & Protects
      • •Prompt Soothing Relief from
        Painful Burning, Itching and
        Discomfort
      • •Also for Nighttime Relief

        • #1 SELLING
        #1
        HEMORRHOID BRAND

        48 SUPPOSITORIES


    * Please review the disclaimer below.