Nupercainal Bio-active Hemorrhoidal
FDA Label NDC 55741-424

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Ducere Pharma for the product Nupercainal Bio-active Hemorrhoidal (NDC 55741-424). 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 other, active ingredients, purpose, use, warnings, otc - when using, stop use and ask a doctor if, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Other

→ Active Ingredients

→ Purpose

→ Use

→ Warnings

→ Otc - When Using

→ Stop Use And Ask A Doctor If

→ Otc - Pregnancy Or Breast Feeding

→ Otc - Keep Out Of Reach Of Children

→ Directions

→ Other Information

→ Inactive Ingredients

→ Questions?

→ Principal Display Panel - 24 Suppository Carton

Other

Drug Facts

Distributed by:
Ducere Pharma • Somerville, NJ 08876 USA

Active Ingredients

Proprietary herbal blend 2x:
    - Echinacea purpurea
    - Centella asiatica
    - Sambucus nigra

Purpose

relief of internal hemorrhoids

Use

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

Otc - When Using

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
condition worsens or does not improve within 7 days

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health care professional before use.

Otc - 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 tissue or a soft cloth before insertion of this product
detach one suppository from the strip; remove the wrapper before inserting into the rectum as follows:
- hold suppository with rounded end up
- as shown, carefully separate tabs by inserting tip of fingernail at end marked "peel down"
- slowly and evenly peel apart (do not tear) by pulling tabs down both sides, to expose the suppository
- remove exposed suppository from wrapper
- insert one suppository into rectum up to 4 times daily, especially at night, in the morning or after each bowel movement
- children under 12 years of age: ask a doctor