Label: AVEDANA HEMORRHOIDAL- hemorrhoidal rectal suppositories suppository
- NDC Code(s): 43749-430-24, 43749-430-25
- Packager: Unipack LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated January 16, 2023
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
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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
- 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
- Keep out of reach of children
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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
- Inactive ingredients
- Carton
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INGREDIENTS AND APPEARANCE
AVEDANA HEMORRHOIDAL
hemorrhoidal rectal suppositories suppositoryProduct 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 2211 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 6.25 mg Inactive Ingredients Ingredient Name Strength METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE) (UNII: 461P5CJN6T) 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:43749-430-24 4 in 1 CARTON 10/26/2020 1 NDC:43749-430-25 6 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 M015 10/26/2020 Labeler - Unipack LLC (009248480) Registrant - Unipack LLC (009248480) Establishment Name Address ID/FEI Business Operations Unipack LLC 009248480 manufacture(43749-430)
