1. Home
  2. Labeler Index
  3. Unipack Llc
  4. 43749-432
  5. Label Information: Revivol-xr

FDA Label for Revivol-xr

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS
    2. PURPOSES
    3. INDICATIONS & USAGE
    4. WARNINGS
    5. ASK A DOCTOR BEFORE USE IF YOU HAVE
    6. OTC - WHEN USING
    7. STOP USE AND ASK A DOCTOR IF
    8. IF PREGNANT OR BREAST-FEEDING,
    9. KEEP OUT OF REACH OF CHILDREN.
    10. DIRECTIONS
    11. OTHER INFORMATION
    12. INACTIVE INGREDIENTS
    13. NDC 43749-432-01

Revivol-xr Product Label

The following document was submitted to the FDA by the labeler of this product Unipack Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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


* Please review the disclaimer below.