drug facts

drug facts
SPL v1
SPL
SPL Set ID ee2ba10c-dce9-46fc-96a2-ff0d119cd1cb
Route
rectal
Published
Effective Date 2010-02-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
cocoa butter (2077 mg) phenylephrine (6 mg) shark liver oil (73 mg)
Inactive Ingredients
methylparaben propylparaben starch, corn

Identifiers & Packaging

Marketing Status
otc monograph final active Since 2005-12-01

Purpose

protectant vasoconstrictor protectant

Description

Cocoa butter, 85.5% Phenylephrine HCI, 0.25% Shark liver oil, 3.0%


Medication Information

Warnings and Precautions



Warnings

For rectal use only.

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

Purpose

protectant

vasoconstrictor

protectant

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
Inactive Ingredients
methylparaben, propylparaben, starch
Description

Cocoa butter, 85.5% Phenylephrine HCI, 0.25% Shark liver oil, 3.0%

Section 42229-5



Section 50570-1


Section 53413-1



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

Cocoa butter, 85.5%



Phenylephrine HCI, 0.25%



Shark liver oil, 3.0%

When Using This Product

do not exceed the recommended daily dosage.

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







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







If Pregnant Or Breastfeeding

 ask a health professional before use.

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.
Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control Center right away.

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.


Structured Label Content

Warnings and Precautions (34071-1)



Warnings (WARNINGS)

For rectal use only.

Uses (USES)
  • Temporarily shrinks hemorrhoidal tissue
  • Temporarily relieves itching burning and discomfort associated with hemorrhoids

Purpose (PURPOSE)

protectant

vasoconstrictor

protectant

Directions (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
Inactive Ingredients (INACTIVE INGREDIENTS)
methylparaben, propylparaben, starch
Section 42229-5 (42229-5)



Section 50570-1 (50570-1)


Section 53413-1 (53413-1)



Storage (STORAGE)
Store in a cool place or at room temperature but not over 86° F.
Active Ingredients (ACTIVE INGREDIENTS)

Cocoa butter, 85.5%



Phenylephrine HCI, 0.25%



Shark liver oil, 3.0%

When Using This Product (When using this product)

do not exceed the recommended daily dosage.

Box Information 12 Count (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







Box Information 24 Count (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







If Pregnant Or Breastfeeding (If pregnant or breastfeeding)

 ask a health professional before use.

Stop Use and Ask A Doctor If (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.
Keep Out of Reach of Children (Keep out of reach of children)

If swallowed, get medical help or contact a Poison Control Center right away.

Ask A Doctor Before Use If You Have (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 (Ask a doctor or pharmacist before use if you are)

presently taking a prescription drug for high blood pressure or depression.


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