RUGBY HEMORRHOIDAL- phenylephrine hydrochloride and fat, hard suppository 
Rugby Laboratories

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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Hemorrhoidal Suppositories

Drug Facts

Active ingredients (in each suppository)Purposes
Hard Fat 88.7%Protectant
Phenylephrine HCl 0.25%Vasoconstrictor

Uses

  • temporarily shrinks hemorrhoidal tissue
  • temporarily 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?

1-800-645-2158

Distributed by:
Rugby Laboratories
17177 N Laurel Park Drive, Suite 233
Livonia, MI 48152 USA

PRINCIPAL DISPLAY PANEL - 12 Suppository Carton

NDC 0536-1389-12

Easy-To-Use
Packaging

Rugby®

Hemorrhoidal
Suppositories

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

12
RECTAL
SUPPOSITORIES

PRINCIPAL DISPLAY PANEL - 12 Suppository Carton
RUGBY HEMORRHOIDAL 
phenylephrine hydrochloride and fat, hard suppository
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-1389
Route of AdministrationRECTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE0.00525 g
FAT, HARD (UNII: 8334LX7S21) (FAT, HARD - UNII:8334LX7S21) FAT, HARD1.86 g
Inactive Ingredients
Ingredient NameStrength
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
STARCH, CORN (UNII: O8232NY3SJ)  
Product Characteristics
Colorwhite (White to off white opaque) Scoreno score
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0536-1389-1212 in 1 CARTON; Type 0: Not a Combination Product04/23/200104/30/2020
2NDC:0536-1389-3524 in 1 CARTON; Type 0: Not a Combination Product04/23/200112/31/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34604/23/200104/30/2020
Labeler - Rugby Laboratories (079246066)

Revised: 9/2019
 
Rugby Laboratories