PREMIER VALUE HEMORRHOIDAL- hemorrhoidal rectal suppositories suppository

Premier Value Hemorrhoidal by

Drug Labeling and Warnings

Premier Value Hemorrhoidal by is a Otc medication manufactured, distributed, or labeled by Chain Drug Consortium, Unipack, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients                                                                        Purpose

(per suppository)

Cocoa butter 88.44%...................................................................Protectant

Phenylephrine hydrochloride 0.25%..............................................Vasoconstrictor

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

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 80oF

Inactive ingredients

methylparaben, propylparaben, starch

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

Ask a doctor before use if you have

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

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,

If pregnant or breast-feeding, ask a health professional before use.

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

Product Label

INGREDIENTS AND APPEARANCE

PREMIER VALUE HEMORRHOIDAL 
hemorrhoidal rectal suppositories suppository

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68016-321
Route of Administration	RECTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
COCOA BUTTER (UNII: 512OYT1CRR) (COCOA BUTTER - UNII:512OYT1CRR)	COCOA BUTTER	88.44 g  in 100 g
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	.25 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
METHYLPARABEN (UNII: A2I8C7HI9T)	.02 g  in 100 g
PROPYLPARABEN (UNII: Z8IX2SC1OH)	.02 g  in 100 g
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE) (UNII: 461P5CJN6T)	11.27 g  in 100 g

Product Characteristics
Color	white	Score
Shape	BULLET	Size	32mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68016-321-13	2 in 1 CARTON
1	NDC: 68016-321-12	12 g in 1 BLISTER PACK

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part346	03/25/2015

Labeler - Chain Drug Consortium (101668460)

Establishment
Name	Address	ID/FEI	Business Operations
Unipack, Inc.		009248480	manufacture(68016-321)