FDA Label for Hemorrhoidal

View Indications, Usage & Precautions

Hemorrhoidal Product Label

The following document was submitted to the FDA by the labeler of this product H E B. 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 (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



Compare to the active ingredients of Preparation H® Hemorrhoidal Suppositories

HEMORRHOIDAL SUPPOSITORIES

Prevents Further Irritation

Helps Shrink Swelling of Irritated Hemorrhoidal Tissues

Gives Prompt Temporary Relief From The Painful Burning, Itching and Discomfort of Hemorrhoids

E-Z Open Wrapper

24 Suppositories


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