MedPath

Walgreens Hemorrhoidal

WALGREENS HEMORRHOIDAL SUPPOSITORIES

Approved
Approval ID

2dd710ac-ab04-4a24-826f-b5a44d058168

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Jul 13, 2025

Manufacturers
FDA

Walgreens

DUNS: 008965063

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Hemorrhoidal Rectal Suppositories

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0363-0476
Application NumberM015
Product Classification
M
Marketing Category
C200263
G
Generic Name
Hemorrhoidal Rectal Suppositories
Product Specifications
Route of AdministrationRECTAL
Effective DateJuly 13, 2025
FDA Product Classification

INGREDIENTS (5)

METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)Inactive
Code: 461P5CJN6T
Classification: IACT
COCOA BUTTERActive
Quantity: 2211 mg in 1 1
Code: 512OYT1CRR
Classification: ACTIB
PHENYLEPHRINE HYDROCHLORIDEActive
Quantity: 6.25 mg in 1 1
Code: 04JA59TNSJ
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 12/17/2020

Label

Carton

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 4/24/2020

When using this product

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

OTC - ASK DOCTOR/PHARMACIST SECTION

LOINC: 50568-5Updated: 4/24/2020

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

OTC - ASK DOCTOR SECTION

LOINC: 50569-3Updated: 4/24/2020

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 unless directed by a doctor

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 4/24/2020

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

LOINC: 53414-9Updated: 4/24/2020

If pregnant or breastfeeding

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 4/24/2020

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. (1-800-222-1222)

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 4/24/2020

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 SECTION

LOINC: 34071-1Updated: 4/24/2020

Warnings

For rectal use only

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 2/5/2024

Drug Facts

Active Ingredients Purpose

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

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

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 4/24/2020

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

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 4/24/2020

Other information

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

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 4/24/2020

Inactive ingredients

corn starch, methylparaben, propylparaben

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Walgreens Hemorrhoidal - FDA Drug Approval Details