Label: PREMIER VALUE HEMORRHOIDAL- hemorrhoidal rectal suppositories suppository

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated March 25, 2015

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  • 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

    HemorrhoidalSuppository24.jpg

  • INGREDIENTS AND APPEARANCE
    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)
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