REVIVOL-XR- phenylephrine hydrochloride suppository

ReVIVOL-XR by

Drug Labeling and Warnings

ReVIVOL-XR by is a Otc medication manufactured, distributed, or labeled by Unipack LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Phenylephrine HCl 0.25%

Purposes

Protectant

Vasoconstrictor

INDICATIONS & 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

Warnings

For rectal use only

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

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

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

• 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)

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.

Other information

store at 15°C-30°C (59°F-86°F)

Inactive ingredients

Aloe Vera Extract and Hydrogenated Palm Kernel Oil

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

INGREDIENTS AND APPEARANCE

REVIVOL-XR 
phenylephrine hydrochloride suppository

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43749-432
Route of Administration	RECTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	6.25 mg

Inactive Ingredients
Ingredient Name	Strength
HYDROGENATED PALM KERNEL OIL (UNII: FM8D1RE2VP)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

Product Characteristics
Color	yellow (Light yellow)	Score	no score
Shape	BULLET (Bullet shaped suppository)	Size	150mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43749-432-01	24 in 1 CARTON	04/01/2025
1		1 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 Drug	M015	04/01/2025

Labeler - Unipack LLC (009248480)

Establishment
Name	Address	ID/FEI	Business Operations
Unipack LLC		009248480	manufacture(43749-432)