AVEDANA HEMORRHOIDAL- hemorrhoidal rectal suppositories suppository

Avedana Hemorrhoidal by

Drug Labeling and Warnings

Avedana Hemorrhoidal by is a Otc medication manufactured, distributed, or labeled by Unipack, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

Label

INGREDIENTS AND APPEARANCE

AVEDANA HEMORRHOIDAL 
hemorrhoidal rectal suppositories suppository

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43749-430
Route of Administration	RECTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
COCOA BUTTER (UNII: 512OYT1CRR) (COCOA BUTTER - UNII:512OYT1CRR)	COCOA BUTTER	88.5 g  in 100 g
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	.26 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
METHYLPARABEN (UNII: A2I8C7HI9T)	.02 g  in 100 g
PROPYLPARABEN (UNII: Z8IX2SC1OH)	.02 g  in 100 g
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE) (UNII: 461P5CJN6T)	11.2 g  in 100 g

Product Characteristics
Color	white	Score
Shape	BULLET	Size	32mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43749-430-13	2 in 1 CARTON	09/17/2017
1	NDC: 43749-430-12	12 g in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part346	09/18/2014

Labeler - Unipack, Inc. (009248480)

Establishment
Name	Address	ID/FEI	Business Operations
Unipack, Inc.		009248480	manufacture(43749-430)