RUGBY HEMORRHOIDAL- phenylephrine hydrochloride and fat, hard suppository

Rugby Hemorrhoidal by

Drug Labeling and Warnings

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

Drug Details [pdf]

Drug Facts

Drug Facts

Active Ingredient

• Active ingredients (in each suppository):

  Purposes

• Hard Fat 88.7%:

  Protectant

• Phenylephrine HCl 0.25%:

  Vasoconstrictor

Uses

• temporarily shrinks hemorrhoidal tissue
• relieves the itching, burning and discomfort associated with hemorrhoids

Warnings

For rectal use only

Ask a doctor before use if you have

• heart disease
• thyroid disease
• high blood pressure
• diabetes
• trouble urinating due to an enlarged prostrate gland

Ask a doctor or pharmacist before use if you are presently taking a prescription drug for high blood pressure or depression

When using this product, do not use more than directed

Stop use and ask a doctor if

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

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

• when practical, cleanse the affected area by patting or blotting with an appropriate cleansing wipe
• gently dry by patting or blotting with a tissue or a soft cloth before insertion of suppository
• detach one suppository from the strip
• separate the two tabs of the white plastic wrap
• with thumb and forefinger of each hand, grasp the tabs and peel downward, unwrapping the suppository
• insert suppository into the rectum

adults and children 12 years and over

insert one suppository rectally up to 4 times daily

children under 12 years

ask a doctor

Other information

store below 30°C (86°F) to avoid melting

Inactive ingredients

corn starch, methylparaben, propylparaben

Questions or comments?

Call 1-800-645-2158

SPL UNCLASSIFIED SECTION

Distributed by:
Rugby Laboratories
31778 Enterprise Drive
Livonia, MI 48150   USA
www.rugbylaboratories.com

Repackaged by Preferred Pharmaceuticals, Inc.

PRINCIPAL DISPLAY PANEL - 12 Suppository Carton

NDC: 68788-0014-1

Easy-To-Use
Packaging

Rugby®

Hemorrhoidal
Suppositories

Temporarily shrinks hemorrhoids and provides prompt
relief from itching, burning and discomfort

Repackaged by Preferred Pharmaceuticals, Inc.

12
RECTAL
SUPPOSITORIES

INGREDIENTS AND APPEARANCE

RUGBY HEMORRHOIDAL 
phenylephrine hydrochloride and fat, hard suppository

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68788-0014(NDC:0536-1389)
Route of Administration	RECTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	0.00525 g
FAT, HARD (UNII: 8334LX7S21) (FAT, HARD - UNII:8334LX7S21)	FAT, HARD	1.86 g

Inactive Ingredients
Ingredient Name	Strength
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
STARCH, CORN (UNII: O8232NY3SJ)

Product Characteristics
Color	WHITE (White to off white opaque)	Score	no score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68788-0014-1	12 in 1 CARTON; Type 0: Not a Combination Product	10/07/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part346	10/07/2013

Labeler - Preferred Pharmaceuticals, Inc. (791119022)

Registrant - Preferred Pharmaceuticals, Inc. (791119022)

Establishment
Name	Address	ID/FEI	Business Operations
Preferred Pharmaceuticals, Inc.		791119022	RELABEL(68788-0014)