Xyralid Hemorrhoidal Suppository
FDA Label NDC 57483-410

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Innovus Pharmaceuticals, Inc. for the product Xyralid Hemorrhoidal (NDC 57483-410). 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, uses, warnings, ask a doctor or pharmacist before use if you are, ask a doctor before use if you have, when using this product, stop use and ask a doctor if, if pregnant or breastfeeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Active Ingredients Purpose

Cocoa butter 88.50%...................................................................Protectant

Phenylephrine hydrochloride 0.26%..............................................Vasoconstrictor

Uses

  • temporarily shrinks hemorrhoidal tissue
  • temporarily relieves itching, burning, and discomfort associated with hemorrhoids
  • aids in protecting irritated anorectal areas

Warnings

For rectal use only

Ask A Doctor Or Pharmacist Before Use If You Are

Ask a doctor or pharmacist before use if you are presently taking a prescription drug for high blood pressure or depression

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

When Using This Product

do not exceed the recommended daily dosage unless directed by a doctor

Stop Use And Ask A Doctor If

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

If Pregnant Or Breastfeeding

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.

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 toilet tissue or a soft cloth.

-remove the wrapper before inserting into the rectum.

-insert one suppository into the rectum up to 4 times daily, especially at night, in the morning or after each bowel movement.

-Children under 12 years of age: consult a doctor

Other Information

Store at 20-25oC (68-77oF)

Inactive Ingredients

corn starch, methylparaben, propylparaben

Purpose

Protectant

Vasoconstrictor

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