HEMORRHOIDAL- cocoa butter, phenylephrine hcl suppository

Hemorrhoidal by

Drug Labeling and Warnings

Hemorrhoidal by is a Otc medication manufactured, distributed, or labeled by Pharmacy Value Alliance LLC, DSC Laboratories Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients (per suppository)

Cocoa butter 88.44%

Phenylephrine hydrochloride 0.25%

Purpose

Protectant

Vasoconstrictor

Uses

• temporarily shrinks hemorrhoidal tissue
• 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
• difficulty in urination due to enlargement of the prostate gland
• high blood pressure
• diabetes

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.

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 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 a doctor

Other information

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

Inactive ingredients

corn starch, methylparaben, propylparaben

Questions or comments?

1-800-492-5988

PRINCIPAL DISPLAY PANEL

The product package shown below represents a sample of that currently in use. Additional packaging may also be available.

Premier Value Hemorrhoidal Suppositories 12ct

Distributed by Pharmacy Value Alliance LLC

407 East Lancaster Avenue

Wayne, PA 19087

785PVHemSupp.jpg

INGREDIENTS AND APPEARANCE

HEMORRHOIDAL 
cocoa butter, phenylephrine hcl suppository

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68016-322
Route of Administration	RECTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
COCOA BUTTER (UNII: 512OYT1CRR) (COCOA BUTTER - UNII:512OYT1CRR)	COCOA BUTTER	2.39 g
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	6.75 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: 68016-322-12	2 in 1 CARTON	08/16/2019
1		6 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 68016-322-24	4 in 1 CARTON	08/16/2019
2		6 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part346	08/16/2019

Labeler - Pharmacy Value Alliance LLC (101668460)

Registrant - DSC Laboratories Inc. (097807374)

Establishment
Name	Address	ID/FEI	Business Operations
DSC Laboratories Inc.		097807374	manufacture(68016-322)