Avedana Hemorrhoidal

Manufacturer
Unipack LLC
Effective date
2023-01-16
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-05-31 23:53:21

Label at a glance#

ProductAvedana Hemorrhoidal
Active ingredientCOCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE
Label structure13 sections

Indications and 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

Dosage and administration

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 inserti...

Storage and handling

Store at 20oC-25oC (68oF-77oF)

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients                                                                        Purpose

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

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

Uses

OTC - PURPOSE SECTION

  • 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

WARNINGS SECTION

For rectal use only

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

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

OTC - ASK DOCTOR SECTION

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

INDICATIONS & USAGE SECTION

When using this product do not exceed the recommended daily dosage unless directed by a doctor

Stop use and ask a doctor 

OTC - STOP USE SECTION

Stop use and ask a doctor if bleeding occurs or if condition worsens or does not improve within 7 days

If pregnant or breastfeeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breastfeeding, ask a health professional before use.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center right away.

Directions: Adults

DOSAGE & ADMINISTRATION SECTION

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

STORAGE AND HANDLING SECTION

Store at 20oC-25oC (68oF-77oF)

Inactive ingredients

INACTIVE INGREDIENT SECTION

corn starch, methylparaben, propylparaben

Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Carton ImageCarton Image

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1438497cocoa butter 88.4 % / phenylephrine HCl 0.25 % Rectal SuppositoryPSN5
1438497cocoa butter 0.884 MG/MG / phenylephrine hydrochloride 0.0025 MG/MG Rectal SuppositorySCD5
1438497cocoa butter 88.4 % / phenylephrine HCl 0.25 % Rectal SuppositorySY5

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
PHENYLEPHRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43749-430-242025-01-30C16284748780-12cef2736-8ba6-d83d-e063-dadaa90ab31fAVEDANA ® 24 ct Hemorrhoidal Rectal Suppository

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43749-430-24Avedana Hemorrhoidal4 in 1 CARTONSUPPOSITORY45
43749-430-25Avedana Hemorrhoidal6 in 1 BLISTER PACKSUPPOSITORY65

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43749-430AVEDANA HEMORRHOIDAL (HEMORRHOIDAL RECTAL SUPPOSITORIES) SUPPOSITORY [UNIPACK LLC]5Legacy NDC, 2 package rows20230120_9009c9f6-81aa-4b32-8161-1fe8e08a6374.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43749-430-12EA - Each43749-430ed6dcb1a-7cac-4cff-b720-b5217e9cd35712024-04-05
43749-430-24EA - Each43749-43085404f34-8931-474c-aebf-3e0f9085265212024-04-05

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43749-43043749-430-25, 43749-430-24

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
f2687ce5-cd32-882a-e053-2a95a90a99229009c9f6-81aa-4b32-8161-1fe8e08a63742023-01-16WarningsExact identifier
spl id: f2687ce5-cd32-882a-e053-2a95a90a9922
spl set id: 9009c9f6-81aa-4b32-8161-1fe8e08a6374

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.