drug facts

drug facts

SPL v1

SPL

SPL Set ID 61c90266-b2ba-4dae-9798-f70824dc0a07

Route

rectal

Published

Effective Date 2010-02-01

Document Type 34390-5 HUMAN OTC DRUG LABEL

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 2009-09-01

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%

Questions?

Call 1-800-910-6874

Section 42229-5

Section 50570-1

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

up and up

NDC 11673-394-53

Hemorrohoidal

Suppositories

Compare to Preparation H® Hemorrhoidal Suppositories*

helps shrink swelling of irritated hemrrhoidal tissues

helps relieve itching, burning and discomfort associated with hemorrhoids

12 SUPPOSITORIES

Dist by Tarted Corp. Minneapolis, MN 55403

© Target Brands, Inc.

All rights reserved. Shop Target.com

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

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

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

Questions?

Call 1-800-910-6874

Section 42229-5 (42229-5)

Section 50570-1 (50570-1)

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)

up and up

NDC 11673-394-53

Hemorrohoidal

Suppositories

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.

Advanced Ingredient Data

[{"name": "cocoa butter", "unii": "512OYT1CRR", "classCode": "ACTIB", "strengthNumerator": "2077", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "methylparaben", "unii": "A2I8C7HI9T", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "propylparaben", "unii": "Z8IX2SC1OH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "starch, corn", "unii": "O8232NY3SJ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "phenylephrine", "unii": "1WS297W6MV", "classCode": "ACTIB", "strengthNumerator": "6", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "shark liver oil", "unii": "4B24275HEU", "classCode": "ACTIB", "strengthNumerator": "73", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}]

Raw Label Data

All Sections (JSON)

{"USES": "Temporarily shrinks hemorrhoidal tissue Temporarily relieves itching burning and discomfort associated with hemorrhoids", "PURPOSE": "protectant vasoconstrictor protectant", "STORAGE": "Store in a cool place or at room temperature but not over 86° F.", "WARNINGS": "For rectal use only.", "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", "Questions?": "Call 1-800-910-6874", "ACTIVE INGREDIENTS": "Cocoa butter, 85.5% Phenylephrine HCI, 0.25% Shark liver oil, 3.0%", "INACTIVE INGREDIENTS": "methylparaben, propylparaben, starch", "When using this product": "do not exceed the recommended daily dosage.", "BOX INFORMATION - 12 count": "up and up NDC 11673-394-53 Hemorrohoidal Suppositories Compare to Preparation H® Hemorrhoidal Suppositories * helps shrink swelling of irritated hemrrhoidal tissues helps relieve itching, burning and discomfort associated with hemorrhoids 12 SUPPOSITORIES Dist by Tarted Corp. Minneapolis, MN 55403 © Target Brands, Inc. All rights reserved. Shop Target.com *This product is not manufactured or distributed by Wyeth Consumer Healthcare, Inc., owner of the registered trademark Preparation H®. FOR YOUR SAFETY, SUPPOSITORIES ARE PACKAGED IN TAMPER-EVIDENT SEALED PLASTIC WRAPPER. DO NOT USE IF PLASTIC WRAPPER IS TORN OR OPEN.", "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."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:00.095734 · Updated: 2026-03-14T22:52:17.029964