Drugplain

PREPARATION H 2211 mg/1

cocoa butter, phenylephrine hydrochloride · SUPPOSITORY · Haleon US Holdings LLC

No Recall History
Plain English

PREPARATION H is a suppository containing cocoa butter, phenylephrine hydrochloride at 2211 mg/1, taken rectal. Manufactured by Haleon US Holdings LLC.

Key Facts

Brand Name
PREPARATION H
Generic Name
cocoa butter, phenylephrine hydrochloride
NDC Code (Product)
0573-2883
Manufacturer
Haleon US Holdings LLC
Strength
2211 mg/1
Dosage Form
SUPPOSITORY
Route
RECTAL
Marketing Status
Application #
M015
Marketing Start
01/05/2004

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
fatigue6,101 reports
condition aggravated5,788 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 contains cocoa butter, phenylephrine hydrochloride. It is a suppository taken rectal. Consult your doctor for specific uses.

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 cocoa butter, phenylephrine hydrochloride. There are 2 other brand versions of cocoa butter, phenylephrine hydrochloride.

What is the NDC code for PREPARATION H 2211 mg/1?

The NDC (National Drug Code) for PREPARATION H 2211 mg/1 is 0573-2883, listed by Haleon US Holdings LLC.

Product NDC

0573-2883

Other PREPARATION H Dosages

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

Data from openFDA · Public domain (CC0 1.0)