Phenylephrine Hydrochloride, Pramoxine Hydrochloride

FDA Drug Information • Also known as: Simple Promise Simple H Hemorrhoid Relief Cream

Brand Names: Simple Promise Simple H Hemorrhoid Relief Cream
Route: TOPICAL
Dosage Form: CREAM
Product Type: HUMAN OTC DRUG

What Is Phenylephrine Hydrochloride, Pramoxine Hydrochloride Used For?

Uses

for temporary relief of pain, soreness and burning

helps relieve the local itching and discomfort associated with hemorrhoids

temporarily shrinks hemorrhoid tissue

temporarily provides a coating for relief of anorectal discomforts

temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful

Dosage and Administration

Directions

: 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 applying cream.

when first opening the tube, puncture foil seal with top end of cap

apply externally or in the lower portion of the anal canal only

apply externally to the affected area 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. Adults

Warnings and Precautions

Warnings For external use only Do not use this product if you have

heart disease

high blood pressure

thyroid disease

diabetes

difficulty in urination due to enlargement of the prostate gland

unless directed by a doctor. 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.

attach the applicator to the tube. Lubricate the applicator well, then gently insert the applicator into the rectum. FOR INTRARECTAL USE: In case of bleeding, consult a doctor promptly. Stop use and ask a doctor if

condition worsens or does not improve within 7 days

an allergic reaction develops

the symptoms being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase. 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.

About This Information

This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.

What are side effects?

Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.

What are drug interactions?

Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.