Revivol-xr Hemorrhoid Suppositories

Revivol-xr Hemorrhoid Suppositories
SPL v2
SPL
SPL Set ID 2950fe83-a2a4-4ed4-b645-69d6fd2381ae
Route
RECTAL
Published
Effective Date 2025-04-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Phenylephrine (6.25 mg)
Inactive Ingredients
Hydrogenated Palm Kernel Oil Aloe Vera Leaf

Identifiers & Packaging

Pill Appearance
Shape: bullet Color: yellow Size: 150 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-04-01
Description

Phenylephrine HCl 0.25%

Purpose

Protectant Vasoconstrictor

Medication Information

Indications and Usage

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
Purpose

Protectant Vasoconstrictor

Description

Phenylephrine HCl 0.25%

Section 50567-7

When using this product

  • do not exceed the recommended daily dosage unless directed by a doctor
  • children under 12 years of age:Ask a doctor
Section 50568-5

presently taking a prescription drug for high blood pressure or depression.

Purposes

Protectant

Vasoconstrictor

Warnings

For rectal use only

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:
    • See full usage instructions with illustrations in the enclosed insert; 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 the suppository. Remove the exposed suppository from the wrapper.
    • Insert one suppository into the rectum up to 4 times daily, especially at night, in the morning or after each bowel movement.
Ndc 43749 432 01

ReVIVOL-XR ®

HEMORRHOIDAL SUPPOSITORIES

Reduces Internal Swelling, Soothes and Protects

  • Prompt Soothing Relief from Painful Burning, Itching and Discomfort
  • Shrinks Swollen Hemorrhoidal Tissue
  • Protects Irritated Tissue
  • Also for Nighttime Relief

24 SUPPOSITORIES

Other Information

store at 15°C-30°C (59°F-86°F)

Active Ingredients

Phenylephrine HCl 0.25%

Inactive Ingredients

Aloe Vera Extract and Hydrogenated Palm Kernel Oil

Stop Use and Ask A Doctor If
  • bleeding occurs
  • condition worsens or does not improve within 7 days
If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

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

Structured Label Content

Indications and Usage (34067-9)

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
Section 50567-7 (50567-7)

When using this product

  • do not exceed the recommended daily dosage unless directed by a doctor
  • children under 12 years of age:Ask a doctor
Section 50568-5 (50568-5)

presently taking a prescription drug for high blood pressure or depression.

Purposes

Protectant

Vasoconstrictor

Warnings

For rectal use only

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:
    • See full usage instructions with illustrations in the enclosed insert; 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 the suppository. Remove the exposed suppository from the wrapper.
    • Insert one suppository into the rectum up to 4 times daily, especially at night, in the morning or after each bowel movement.
Ndc 43749 432 01 (NDC 43749-432-01)

ReVIVOL-XR ®

HEMORRHOIDAL SUPPOSITORIES

Reduces Internal Swelling, Soothes and Protects

  • Prompt Soothing Relief from Painful Burning, Itching and Discomfort
  • Shrinks Swollen Hemorrhoidal Tissue
  • Protects Irritated Tissue
  • Also for Nighttime Relief

24 SUPPOSITORIES

Other Information (Other information)

store at 15°C-30°C (59°F-86°F)

Active Ingredients

Phenylephrine HCl 0.25%

Inactive Ingredients (Inactive ingredients)

Aloe Vera Extract and Hydrogenated Palm Kernel Oil

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • bleeding occurs
  • condition worsens or does not improve within 7 days
If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

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. (1-800-222-1222)

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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:06:30.648534 · Updated: 2026-03-14T23:09:19.585027