Drug Facts:
Active ingredient Purpose
(in each suppository)
Phenylephrine Hydrochloride 0.25% ........................... Vasoconstrictor
Phenylephrine Hemorrhoidal Suppository
FDA Label NDC 13709-330
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Neilmed Pharmaceuticals Inc. for the product Phenylephrine Hemorrhoidal (NDC 13709-330). 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 drug facts:, uses, warnings, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product:, stop use and ask 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
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 prostate gland
Ask A Doctor Or Pharmacist Before Use If You Are
presently taking a prescription drug for high blood pressure or depression.
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 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)
Other Information:
• Store at 20° - 25°C (68° - 77°F)
• Lot No. & Exp. Date: see wrapper or box
Inactive Ingredients:
Cocoa butter, methylparaben, propylparaben, topical starch
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 as shown in the illustration • Insert one suppository into the rectum pointed end first, up to 4 times daily, especially at night, in the morning or after each bowel movement.
Important:
Please do not discard this printed box and any enclosed printed material. The inside final product may not have all the details you require for the ongoing use of the product.
Purpose
Purpose - Vasoconstrictor
Package Label
Phenylephrine Suppositories (Phenylephrine)
* Please review the disclaimer below.
