FDA Label for Avedana Hemorrhoidal
View Indications, Usage & Precautions
Avedana Hemorrhoidal Product Label
The following document was submitted to the FDA by the labeler of this product Unipack 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.
Drug Facts
Active Ingredients Purpose
Cocoa butter 88.44%...................................................................Protectant
Phenylephrine hydrochloride 0.25%..............................................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 Or Pharmacist Before Use If You Are
Ask a doctor or pharmacist before use if you are presently taking a prescription drug for high blood pressure or depression
Ask A Doctor Before Use If You Have
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
When Using This Product
When using this product do not exceed the recommended daily dosage unless directed by a doctor
Stop Use And Ask A Doctor
Stop use and ask a doctor if bleeding occurs or if condition worsens or does not improve within 7 days
If Pregnant Or Breastfeeding
If pregnant or breastfeeding, ask a health professional before use.
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
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 from wrapper
-insert on 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 20oC-25oC (68oF-77oF)
Inactive Ingredients
corn starch, methylparaben, propylparaben
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