NDC 43749-430 Avedana Hemorrhoidal

Hemorrhoidal Rectal Suppositories

NDC Product Code 43749-430

NDC 43749-430-13

Package Description: 2 BLISTER PACK in 1 CARTON > 12 g in 1 BLISTER PACK (43749-430-12)

NDC 43749-430-25

Package Description: 4 BLISTER PACK in 1 CARTON > 12 g in 1 BLISTER PACK (43749-430-24)

NDC Product Information

Avedana Hemorrhoidal with NDC 43749-430 is a a human over the counter drug product labeled by Unipack, Inc.. The generic name of Avedana Hemorrhoidal is hemorrhoidal rectal suppositories. The product's dosage form is suppository and is administered via rectal form.

Labeler Name: Unipack, Inc.

Dosage Form: Suppository - A solid body of various weights and shapes, adapted for introduction into the rectal orifice of the human body; they usually melt, soften, or dissolve at body temperature.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Avedana Hemorrhoidal Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • COCOA BUTTER 88.5 g/100g
  • PHENYLEPHRINE HYDROCHLORIDE .26 g/100g
  • COCOA BUTTER 88.5 g/100g
  • PHENYLEPHRINE HYDROCHLORIDE .26 g/100g

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE) (UNII: 461P5CJN6T)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Rectal - Administration to the rectum.
  • Rectal - Administration to the rectum.
  • Rectal - Administration to the rectum.
  • Rectal - Administration to the rectum.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Unipack, Inc.
Labeler Code: 43749
FDA Application Number: part346 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 10-26-2020 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Avedana Hemorrhoidal Product Label Images

Avedana Hemorrhoidal Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Drug Facts

Active Ingredients                                                                        PurposeCocoa butter 88.44%...................................................................ProtectantPhenylephrine hydrochloride 0.25%..............................................Vasoconstrictor

Uses

  • Helps relieve the local itching and discomfort associated with hemorrhoidstemporarily relieves burning and shrinks hemorrhoidal tissuetemporarily provides a coating for relief of anorectal discomfortstemporarily 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

* Please review the disclaimer below.