Avedana Hemorrhoidal
FDA Label NDC 43749-430

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Unipack Llc for the product Avedana Hemorrhoidal (NDC 43749-430). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding drug facts, uses, warnings, ask a doctor or pharmacist before use if you are, ask a doctor before use if you have, when using this product, stop use and ask a doctor, if pregnant or breastfeeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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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