HEMORRODIL- phenylephrine hydrochloride and cocoa butter suppository

Hemorrodil by

Drug Labeling and Warnings

Hemorrodil by is a Otc medication manufactured, distributed, or labeled by ZURICH MEDICAL LABS, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active Ingredients	Purpose
Phenylephrine Hydrochloride 0.25%	Vasoconstrictor
Cocoa Butter 88.44%	Protectant

Uses

• Temporarily shrinks hemorrhoidal tissues
• Provides temporary relief from the itching, burning and discomfort associated with hemorrhoids
• Aids in protecting irritated anorectal areas

Warning

For rectal use only

Ask a doctor or pharmacist before use if you are presently taking a prescription drug for high blood pressure or depression.

Ask a doctor before use if you have

• heart disease
• high blood pressure
• thyroid disease
• diabetes
• difficulty in urination due to enlargement of the prostate gland

When using this product

• do not exceed recommended daily dose unless directed by a doctor
• in case of bleeding or if condition worsens or does not improve within 7 days, consult a doctor promptly.

If pregnant or breast-feeding, 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

• detach one suppository from the strip. Remove wrapper before inserting into rectum
• gently insert suppository into rectum up to 4 times daily, especially at night, in the morning or after each bowel movement.

Children under 12 years of age, consult a doctor

Other information

Store at temperature 59° – 86°F

Inactive ingredients

methylparaben, propylparaben, starch

PRINCIPAL DISPLAY PANEL - 12 Suppository Blister Pack Carton

HEMORRODIL®

Soothing &
Refreshing

12 SUPPOSITORIES

INGREDIENTS AND APPEARANCE

HEMORRODIL 
phenylephrine hydrochloride and cocoa butter suppository

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61357-135
Route of Administration	RECTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg
COCOA BUTTER (UNII: 512OYT1CRR) (COCOA BUTTER - UNII:512OYT1CRR)	COCOA BUTTER	1768.8 mg

Inactive Ingredients
Ingredient Name	Strength
STARCH, CORN (UNII: O8232NY3SJ)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61357-135-01	1 in 1 CARTON
1		12 in 1 BLISTER PACK

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part346	03/01/1964

Labeler - ZURICH MEDICAL LABS, LLC (071904097)

Establishment
Name	Address	ID/FEI	Business Operations
ZURICH MEDICAL LABS, LLC		071904097	MANUFACTURE(61357-135)