Active Ingredients (Per Suppository)
Cocoa butter 88.44%
Phenylephrine hydrochloride 0.25%
Hemorrhoidal Suppository
FDA Label NDC 46122-777
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Amerisourcebergen Drug Corporation for the product Hemorrhoidal (NDC 46122-777). 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
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: 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 soft cloth before insertion of this product.
- Detach one suppository from the strip; remove plastic wrapper before inserting into the rectum as follows:
- hold suppository with rounded end up
- as shown, carefully separate plastic tabs by inserting tip of finger nail at end marked "peep here"
- slowly and evenly peel apart (do not tear) plastic by pulling tabs down both sides, to expose the suppository
- remove exposed suppository from wrapper
- insert on suppository into the rectum up to 4 times daily, especially at night, in the morning or after each bowl movement
- children under 12 years of age ask a doctor
Other Information
store at 20-25°C (68-77°F)
Inactive Ingredients
corn starch, methylparaben, propylparaben
Questions Or Comments?
1-800-492-5988
Package Label.Principal Display Panel
The product package shown below represents a sample of that currently in use. Additional packaging may also be available.
GNP Hemorrhoidal Suppositories 12ct
Distributed Amerisource Bergen
1 West First Avenue
Conshohocken, PA 19428
785PVHemSupp.jpg
Gnp Hemorrhoidal Suppositories (785gnphemsupp)
* Please review the disclaimer below.
