COCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE, SHARK LIVER OIL suppository

cocoa butter, phenylephrine hydrochloride, shark liver oil by

Drug Labeling and Warnings

cocoa butter, phenylephrine hydrochloride, shark liver oil by is a Otc medication manufactured, distributed, or labeled by H and P Industries, Inc. dba Triad Group. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

SPL UNCLASSIFIED SECTION

STORAGE

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

INACTIVE INGREDIENTS

methylparaben, propylparaben, starch

QUESTIONS

PACKAGE INFORMATION

NDC: 50730-1481-1
Cat. No. 10-14812

TRIAD®

HEMORRHOIDAL
SUPPOSITORIES

Temporarily relieves itching and discomfort associated with hemorrhoids
Individually wrapped unit dose

12 suppositories

Triad Group, Inc.
Brookfield, WI 53045 USA

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

INGREDIENTS AND APPEARANCE

COCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE, SHARK LIVER OIL 
cocoa butter, phenylephrine hydrochloride, shark liver oil suppository

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50730-1481
Route of Administration	RECTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
cocoa butter (UNII: 512OYT1CRR) (cocoa butter - UNII:512OYT1CRR)	cocoa butter	2077 mg
phenylephrine hydrochloride (UNII: 04JA59TNSJ) (phenylephrine - UNII:1WS297W6MV)	phenylephrine hydrochloride	6 mg
shark liver oil (UNII: 4B24275HEU) (shark liver oil - UNII:4B24275HEU)	shark liver oil	73 mg

Inactive Ingredients
Ingredient Name	Strength
methylparaben (UNII: A2I8C7HI9T)
propylparaben (UNII: Z8IX2SC1OH)
starch, corn (UNII: O8232NY3SJ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50730-1481-1	12 in 1 BOX

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part346	03/06/2004

Labeler - H and P Industries, Inc. dba Triad Group (050259597)

Registrant - H and P Industries, Inc. dba Triad Group (050259597)

Establishment
Name	Address	ID/FEI	Business Operations
H and P Industries, Inc. dba Triad Group		050259597	manufacture