Hemorrhoidal Suppository
FDA Label NDC 68016-322

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Pharmacy Value Alliance Llc for the product Hemorrhoidal (NDC 68016-322). 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 (per suppository), purpose, uses, warnings, ask a doctor or pharmacist before use if you are, ask a doctor before use if you have, when using this product, 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 (per Suppository)

→ Purpose

→ Uses

→ Warnings

→ Ask A Doctor Or Pharmacist Before Use If You Are

→ Ask A Doctor Before Use If You Have

→ When Using This Product

→ If Pregnant Or Breast-feeding,

→ Keep Out Of Reach Of Children.

→ Directions

→ Other Information

→ Inactive Ingredients

→ Questions Or Comments?

→ Package Label.principal Display Panel

Active Ingredients (Per Suppository)

Cocoa butter 88.44%

Phenylephrine hydrochloride 0.25%

Purpose

Protectant

Vasoconstrictor

Uses

temporarily shrinks hemorrhoidal tissue
gives temporary relief to the 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

presently taking a prescription drug for high blood pressure or depression

Ask A Doctor Before Use If You Have

heart disease
thyroid disease
difficulty in urination due to enlargement of the prostate gland
high blood pressure
diabetes

When Using This Product

do not exceed the recommended daily dosage unless directed by a doctor
in case of bleeding or if condition worsens or does not improve within 7 days, consult a doctor promptly

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

Directions

Adults

detach one suppository from the strip. 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