Drug Facts
Active Ingredients Purpose
(per suppository)
Cocoa butter 85.5%...............................................Protectant
Phenylephrine hydrochloride 0.25%................Vasoconstructor
Hemorrhoidal
FDA Label NDC 54162-045
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Geritrex Corp. for the product Hemorrhoidal (NDC 54162-045). 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, directions, dosage & administration, warnings, inactive ingredient, storage, keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Uses
temporarily shrinks hemorrhoidal tissues
gives temporary relief to the itching,burning and
discomfort associated with hemorrhoids
aids in protecting irritated anorectal areas
Directions
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
Dosage & Administration
Children under 12 years of age: consult a doctor
Warnings
For rectal use only
Ask a doctor or pharmacist before use if your 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 diffculty urination due to enlargement of
the prostate gland
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
Inactive Ingredient
methylparaben,propylparaben,shark liver oil,starch
Storage
Store at room temperature or in a cool place
but not over 80° F
Keep Out Of Reach Of Children
If swallowed, get medical help or
contact a Poison Control Center right away
* Please review the disclaimer below.
