Phenylephrine Hydrochloride
FDA Label NDC 0363-0394

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Walgreen Company for the product Phenylephrine Hydrochloride (NDC 0363-0394). 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, purpose, uses, warnings, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Cocoa butter, 85.5%

Phenylephrine HCI, 0.25%

Shark liver oil, 3.0%

Purpose

protectant

vasoconstrictor

protectant

Uses

  • Temporarily shrinks hemorrhoidal tissue
  • Temporarily relieves itching burning and discomfort associated with hemorrhoids

Warnings

For rectal use only.


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

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.

Stop Use And Ask A Doctor If

  • you experience bleeding
  • condition worsens or does not improve within 7 days.
    • These may be signs of a serious condition.

If Pregnant Or Breastfeeding

 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 tissue. Gently dry by patting or blotting with toilet tissue or soft cloth before insertion of this product.
  • Detach one suppository from strip
  • Remove wrapper before inserting into rectum
  • Hold suppository with rounded end up and insert tip of fingernail at end marked "peel down"
  • Carefully peel film slowly and evenly down both sides to expose suppository
  • Insert one suppository into rectum up to 4 times daily especially at night and morning or after each bowel movement
    • Children under 12 years:  ask a doctor

Other


Storage

Store in a cool place or at room temperature but not over 86° F.

Inactive Ingredients

Methylparaben, propylparaben, starch

Otc - Questions


Box Information - 12 Count

Walgreens

NDC 0363-0394-53

Hemorrhoidal
Suppositories

  • Temporary relief of burning, itching and discomfort
  • Shrinks swelling of irritated hemorrhoidal tissue
  • Protects irritated tissue
  • Also provides nighttime relief
    • Compare to Preparation H Suppositories® active ingredients*

    12 SUPPOSITORIES

    FOR YOUR SAFETY, SUPPOSITORIES ARE PACKAGED IN TAMPER-EVIDENT SEALED PLASTIC WRAPPER. DO NOT USE IF PLASTIC WRAPPER IS TORN OR OPEN.

    *This product is not manufactured or distributed by Wyeth Consumer Healthcare, Inc., owner of the registered trademark Preparation H®.

    Distributed by Walgreens Company, Deerfield, IL 60015-4616
    100% Satisfaction Guaranteed    www.walgreens.com
    12 Count Box (33 14812wal A)

    12 Count Box (33 14812wal A)




Box Information - 24 Count

Walgreens

NDC 0363-0394-62

Hemorrhoidal
Suppositories

  • Temporary relief of burning, itching and discomfort
  • Shrinks swelling of irritated hemorrhoidal tissue
  • Protects irritated tissue
  • Also provides nighttime relief


    • Compare to Preparation H Suppositories® active ingredients*

    24 SUPPOSITORIES

    FOR YOUR SAFETY, SUPPOSITORIES ARE PACKAGED IN TAMPER-EVIDENT SEALED PLASTIC WRAPPER. DO NOT USE IF PLASTIC WRAPPER IS TORN OR OPEN.

    *This product is not manufactured or distributed by Wyeth Consumer Healthcare, Inc., owner of the registered trademark Preparation H®.

    Distributed by Walgreens Company, Deerfield, IL 60015-4616
    100% Satisfaction Guaranteed    www.walgreens.com


    24 Count Box (33 14824wal A)

    24 Count Box (33 14824wal A)



* Please review the disclaimer below.