PREMIER VALUE HEMORRHOIDAL- hemorrhoidal rectal suppositories suppository 
Chain Drug Consortium

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active Ingredients                                                                        Purpose

(per suppository)

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

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

Uses

Warnings

For rectal use only

Directions

Adults

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

HemorrhoidalSuppository24.jpg

PREMIER VALUE HEMORRHOIDAL 
hemorrhoidal rectal suppositories suppository
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-321
Route of AdministrationRECTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
COCOA BUTTER (UNII: 512OYT1CRR) (COCOA BUTTER - UNII:512OYT1CRR) COCOA BUTTER88.44 g  in 100 g
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE.25 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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
ColorwhiteScore    
ShapeBULLETSize32mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68016-321-132 in 1 CARTON
1NDC:68016-321-1212 g in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34603/25/2015
Labeler - Chain Drug Consortium (101668460)
Establishment
NameAddressID/FEIBusiness Operations
Unipack, Inc.009248480manufacture(68016-321)

Revised: 3/2015
Document Id: 5a42c7d9-b02a-496c-8870-0eb17e607a0f
Set id: 8638a48e-9f90-4cab-abc1-5407afe498df
Version: 1
Effective Time: 20150325
 
Chain Drug Consortium