XYRALID HEMORRHOIDAL- hemorrhoidal suppositories suppository

Xyralid Hemorrhoidal by

Drug Labeling and Warnings

Xyralid Hemorrhoidal by is a Otc medication manufactured, distributed, or labeled by Innovus Pharmaceuticals, Inc., Unipack, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Active Ingredients Purpose

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

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

Uses

• temporarily shrinks hemorrhoidal tissue
• temporarily relieves itching, burning, and discomfort associated with hemorrhoids
• aids in protecting irritated anorectal areas

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

INGREDIENTS AND APPEARANCE

XYRALID HEMORRHOIDAL 
hemorrhoidal suppositories suppository

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57483-410
Route of Administration	RECTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
COCOA BUTTER (UNII: 512OYT1CRR) (COCOA BUTTER - UNII:512OYT1CRR)	COCOA BUTTER	88.5 g  in 100 g
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	0.26 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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
Color	white	Score
Shape	BULLET	Size	32mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57483-410-13	4 in 1 CARTON	03/25/2018
1	NDC: 57483-410-12	24 g in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part346	03/25/2018

Labeler - Innovus Pharmaceuticals, Inc. (962507187)

Establishment
Name	Address	ID/FEI	Business Operations
Unipack, Inc.		009248480	manufacture(57483-410)