AVEDANA HEMORRHOIDAL- hemorrhoidal rectal suppositories suppository 
Unipack LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Avedana ® 12 ct Hemorrhoidal Rectal Suppository

Drug Facts

Active Ingredients                                                                        Purpose

Cocoa butter 88.44%...................................................................Protectant

Phenylephrine hydrochloride 0.25%..............................................Vasoconstrictor

Uses

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

-t hyroid 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

Carton Label

AVEDANA HEMORRHOIDAL 
hemorrhoidal rectal suppositories suppository
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43749-430
Route of AdministrationRECTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
COCOA BUTTER (UNII: 512OYT1CRR) (COCOA BUTTER - UNII:512OYT1CRR) COCOA BUTTER2211 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE6.25 g
Inactive Ingredients
Ingredient NameStrength
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE) (UNII: 461P5CJN6T)  
Product Characteristics
ColorwhiteScore    
ShapeBULLETSize32mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43749-430-122 in 1 CARTON09/17/2017
1NDC:43749-430-136 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM01509/18/2014
Labeler - Unipack LLC (009248480)
Registrant - Unipack LLC (009248480)
Establishment
NameAddressID/FEIBusiness Operations
Unipack LLC009248480manufacture(43749-430)

Revised: 1/2023
Document Id: f265e7a5-711f-c5bd-e053-2a95a90a4667
Set id: 4defc910-1f4b-4a87-8bdd-9d71d8cadd93
Version: 8
Effective Time: 20230116
 
Unipack LLC