HEMORRHOIDAL- cocoa butter, phenylephrine hydrochloride suppository

Hemorrhoidal by

Drug Labeling and Warnings

Hemorrhoidal by is a Otc medication manufactured, distributed, or labeled by Chain Drug Marketing Association, Inc., Acino Products, LLC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug facts Active Ingredients

Active Ingredients
(per suppository)

Cocoa butter 88.44 %
Phenylephrine hydrochloride 0.25 %

Purposes

Protectant
Vasoconstructor

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.

Uses

• temporarily shrinks hemorrhoidal tissues
• gives temporary relief to the itching, burning and discomfort associated with hemorrhoids
• aids in protecting irritated anorectal areas

Warnings

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

When using this product

• do not exceed the recommended daily dosage 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.

Directions Adults

• detach one suppository from the strip. Remove the wrapper before inserting into the rectum.
• insert one suppository into the rectum up to 4 times daily, especially at night, in the morning or after each bowel movement. Children under 12 years of age: consult doctor

Other Information

Store at room temperature or in a cool place but not over 80° F

Inactive ingredients

methylparaben, propylparaben, starch

Hemorrhoidal Suppositories Product Label

NDC: 63868-208-12

QC QUALITY CHOICE

*Compare to the active ingredient in PREPARATION H®

HEMORRHOIDAL SUPPOSITORIES
Reduces Internal Swelling l Soothes and Protects

Cocoa Butter 88.4% l Phenylephrine Hydrochloride 0.25%
Prompt Soothing Relief From Painful Burning, Itching, and Discomfort
Provides Additional Nighttime Relief

12 ADULT SUPPOSITORIES

SATISFACTION GUARANTEED QC 100%

Distributed by C.D.M.A. Inc.©
43157 W. Nine Mile
Novi, MI 48376-0995
www.qualitychoice.com
Questions: 248-449-9300

Easy Open

*This product is not manufactured or distributed by Pfizer Consumer Healthcare., distributor of Preparation H®.

INGREDIENTS AND APPEARANCE

HEMORRHOIDAL 
cocoa butter, phenylephrine hydrochloride suppository

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63868-208
Route of Administration	RECTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
COCOA BUTTER (UNII: 512OYT1CRR) (COCOA BUTTER - UNII:512OYT1CRR)	COCOA BUTTER	1768.8 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 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: 63868-208-12	12 in 1 BOX
1		1 in 1 BLISTER PACK
2	NDC: 63868-208-24	24 in 1 BOX
2		1 in 1 BLISTER PACK

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part346	09/26/2007

Labeler - Chain Drug Marketing Association, Inc. (011920774)

Registrant - Acino Products, LLC. (019385518)

Establishment
Name	Address	ID/FEI	Business Operations
Acino Products, LLC.		019385518	manufacture(63868-208)