HEMORRODIL- phenylephrine hydrochloride and cocoa butter suppository 
ZURICH MEDICAL LABS, LLC

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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Hemorrodil® Supositorios

Drug Facts

Active IngredientsPurpose
Phenylephrine Hydrochloride 0.25%Vasoconstrictor
Cocoa Butter 88.44%Protectant

Uses

Warning

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

When using this product

  • do not exceed recommended daily dose 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 wrapper before inserting into rectum
  • gently insert suppository into 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 temperature 59° – 86°F

Inactive ingredients

methylparaben, propylparaben, starch

PRINCIPAL DISPLAY PANEL - 12 Suppository Blister Pack Carton

HEMORRODIL®

Soothing &
Refreshing

12 SUPPOSITORIES

Principal Display Panel - 12 Suppository Blister Pack Carton
HEMORRODIL 
phenylephrine hydrochloride and cocoa butter suppository
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61357-135
Route of AdministrationRECTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
COCOA BUTTER (UNII: 512OYT1CRR) (COCOA BUTTER - UNII:512OYT1CRR) COCOA BUTTER1768.8 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN (UNII: O8232NY3SJ)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61357-135-011 in 1 CARTON
112 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34603/01/1964
Labeler - ZURICH MEDICAL LABS, LLC (071904097)
Establishment
NameAddressID/FEIBusiness Operations
ZURICH MEDICAL LABS, LLC071904097MANUFACTURE(61357-135)

Revised: 3/2014
Document Id: 5a877b42-8cce-4c0a-a2ef-3324577ad4d2
Set id: 1c704359-89a4-449c-961c-ad527cb467c2
Version: 1
Effective Time: 20140311
 
ZURICH MEDICAL LABS, LLC