XYRALID HEMORRHOIDAL- hemorrhoidal suppositories suppository 
Innovus Pharmaceuticals, Inc.

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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Active ingredients

Active Ingredients Purpose

Cocoa butter 88.50%...................................................................Protectant

Phenylephrine hydrochloride 0.26%..............................................Vasoconstrictor

Uses

Warnings

For rectal use only

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

-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 the recommended daily dosage unless directed by a doctor

Stop use and ask a doctor if

bleeding occurs or condition worsens or does not improve within 7 days

If pregnant or breastfeeding

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.

Directions

-Adults: when practical, cleanse the affected area by patting or blotting with an appropriate cleansing wipe.  Gently dry by patting or blotting with a toilet tissue or a soft cloth.

-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 20-25oC (68-77oF)

Inactive ingredients

corn starch, methylparaben, propylparaben

Purpose

Protectant

Vasoconstrictor

Carton Label

Carton Label

XYRALID HEMORRHOIDAL 
hemorrhoidal suppositories suppository
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57483-410
Route of AdministrationRECTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
COCOA BUTTER (UNII: 512OYT1CRR) (COCOA BUTTER - UNII:512OYT1CRR) COCOA BUTTER88.5 g  in 100 g
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE0.26 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
METHYLPARABEN (UNII: A2I8C7HI9T) 0.02 g  in 100 g
PROPYLPARABEN (UNII: Z8IX2SC1OH) 0.02 g  in 100 g
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE) (UNII: 461P5CJN6T) 11.2 g  in 100 g
Product Characteristics
ColorwhiteScore    
ShapeBULLETSize32mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57483-410-134 in 1 CARTON03/25/2018
1NDC:57483-410-1224 g in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34603/25/2018
Labeler - Innovus Pharmaceuticals, Inc. (962507187)
Establishment
NameAddressID/FEIBusiness Operations
Unipack, Inc.009248480manufacture(57483-410)

Revised: 5/2018
Document Id: cd6eb255-a89d-40c5-90a0-13f907ab0ad5
Set id: 8a885822-42e7-44e0-82d6-fa967123866e
Version: 1
Effective Time: 20180503
 
Innovus Pharmaceuticals, Inc.