ReVIVOL-XR

Manufacturer
Unipack LLC
Effective date
2025-07-13
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:07:12

Label at a glance#

ProductReVIVOL-XR
Active ingredientPHENYLEPHRINE HYDROCHLORIDE
Label structure7 sections

Dosage and administration

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 b...

Storage and handling

store at 15°C-30°C (59°F-86°F)

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Phenylephrine HCl 0.25%

Purposes

OTC - PURPOSE SECTION

Protectant

Vasoconstrictor

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

For rectal use only

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • difficulty in urination due to enlargement of the prostate gland

OTC - ASK DOCTOR/PHARMACIST SECTION

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

OTC - WHEN USING SECTION

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

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • bleeding occurs
  • condition worsens or does not improve within 7 days

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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.

Other information

STORAGE AND HANDLING SECTION

store at 15°C-30°C (59°F-86°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aloe Vera Extract and Hydrogenated Palm Kernel Oil

NDC 43749-432-01

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

image descriptionimage description

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43749-432-01ReVIVOL-XR1 in 1 BLISTER PACKSUPPOSITORY12
43749-432-01ReVIVOL-XR24 in 1 CARTONSUPPOSITORY242

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43749-43243749-432-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 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
ReVIVOL-XRPHENYLEPHRINE HYDROCHLORIDEUnipack LLC2950fe83-a2a4-4ed4-b645-69d6fd2381ae2025-07-13WarningsExact identifier
ndc (package): 43749-432-01
ndc (product): 43749-432
ndc11 (package): 43749043201
spl id: 39db2684-3085-e26e-e063-6394a90ae422
spl set id: 2950fe83-a2a4-4ed4-b645-69d6fd2381ae

Reported adverse events (FAERS/openFDA)#

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