Revivol-xr Suppository
FDA Label NDC 43749-432

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Unipack Llc for the product Revivol-xr (NDC 43749-432). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients, purposes, indications & usage, warnings, ask a doctor before use if you have, otc - when using, stop use and ask a doctor if, if pregnant or breast-feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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

Otc - When Using

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

    Image Description (Revivolxr)

    Image Description (Revivolxr)

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