Drugplain

PREPARATION H 6.25 mg/1

Phenylephrine hydrochloride · SUPPOSITORY · Haleon US Holdings LLC

No Recall History
Plain English

Preparation H suppositories contain phenylephrine, a decongestant that helps relieve hemorrhoid symptoms like itching, burning, and discomfort when inserted rectally. This product is available over-the-counter without a prescription.

Key Facts

Brand Name
PREPARATION H
Generic Name
Phenylephrine hydrochloride
NDC Code (Product)
0573-2919
Manufacturer
Haleon US Holdings LLC
Strength
6.25 mg/1
Dosage Form
SUPPOSITORY
Route
RECTAL
Marketing Status
Application #
M015
Marketing Start
04/30/2025

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

off label use9,834 reports
drug ineffective7,824 reports
fatigue6,100 reports
condition aggravated5,789 reports
rash5,193 reports
nausea5,179 reports
pain4,877 reports
headache4,663 reports
diarrhoea4,644 reports
arthralgia4,592 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses helps relieve the local itching and discomfort associated with hemorrhoids temporary relief of irritation and burning aids in protecting irritated anorectal areas

Dosage & Administration

Directions adults: unfold wipe and cleanse the area by gently wiping, patting or blotting. If necessary, repeat until all matter is removed from the area. use up to 6 times daily or after each bowel movement and before applying topical hemorrhoidal treatments, and then discard children under 12 years of age: consult a doctor

Warnings

Warnings For external use only When using this product do not exceed the recommended daily dosage unless directed by a doctor do not put this product into the rectum by using fingers or any mechanical device or applicator Stop use and ask a doctor if bleeding occurs condition worsens or does not improve within 7 days Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Frequently Asked Questions

What is PREPARATION H used for?

Preparation H suppositories contain phenylephrine, a decongestant that helps relieve hemorrhoid symptoms like itching, burning, and discomfort when inserted rectally. This product is available over-the-counter without a prescription.

Is PREPARATION H a controlled substance?

PREPARATION H is not classified as a controlled substance by the DEA.

What is the generic name for PREPARATION H?

The generic name for PREPARATION H is Phenylephrine hydrochloride. There are 12 other brand versions of Phenylephrine hydrochloride.

What is the NDC code for PREPARATION H 6.25 mg/1?

The NDC (National Drug Code) for PREPARATION H 6.25 mg/1 is 0573-2919, listed by Haleon US Holdings LLC.

Product NDC

0573-2919

Package NDC

0573-2919-12

Other Phenylephrine Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)