ASPIRIN REGULAR STRENGTH- aspirin tablet, delayed release 
Rugby Laboratories

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Rugby 44-227

Active ingredient (in each tablet)

Aspirin 325 mg (NSAID*)
*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever

Uses

Warnings

Reye’s syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.

Allergy alert: Aspirin may cause a severe allergic reaction which may include:

Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you

Do not use

if you have ever had an allergic reaction to any other pain reliever/fever reducer

Ask a doctor before use if

  • stomach bleeding warning applies to you
  • you have a history of stomach problems, such as heartburn
  • you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
  • you are taking a diuretic
  • you have asthma

Ask a doctor or pharmacist before use if you are

taking a prescription drug for

  • diabetes
  • gout
  • arthritis

Stop use and ask a doctor if

  • an allergic reaction occurs. Seek medical help right away.
  • you experience any of the following signs of stomach bleeding:
    • feel faint
    • vomit blood
    • have bloody or black stools
    • have stomach pain that does not get better
  • ringing in the ears or loss of hearing occurs
  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • any new symptoms appear

If pregnant or breast-feeding,

ask a health professional before use. It is especially important not to use aspirin at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away

Directions

Other information

Inactive ingredients

black iron oxide, cellulose, colloidal anhydrous silica, D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, methacrylic acid and ethyl acrylate copolymer, microcrystalline cellulose, polydextrose, polyethylene glycol, pregelatinized starch, propylene glycol, shellac wax, simethicone, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triacetin, triethyl citrate

Questions or comments?

1-800-426-9391

Principal display panel

Rugby®

NDC 0536-1232-01

compare to the active ingredient
in Ecotrin® Regular Strength

regular strength
aspirin
aspirin 325 mg
pain reliever (NSAID)

safety coated
for the temporary relief of minor arthritis pain

100 enteric coated tablets

actual size

TAMPER EVIDENT: DO NOT USE IF IMPRINTED
SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

This product is not manufactured or distributed by Medtech
Products Inc., owner of the registered trademark
Ecotrin® Regular Strength.    50844         ORG032522712

Distributed by:
RUGBY® LABORATORIES
Indianapolis, IN 46268
(800) 616-2471
www.major-rugby.com

Rugby 44-227A

Rugby 44-227A

ASPIRIN  REGULAR STRENGTH
aspirin tablet, delayed release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-1232
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN325 mg
Inactive Ingredients
Ingredient NameStrength
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
D&C YELLOW NO. 10 ALUMINUM LAKE (UNII: CQ3XH3DET6)  
FD&C YELLOW NO. 6 ALUMINUM LAKE (UNII: GYP6Z2JR6Q)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER (UNII: NX76LV5T8J)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYDEXTROSE (UNII: VH2XOU12IE)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
STARCH, CORN (UNII: O8232NY3SJ)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SHELLAC (UNII: 46N107B71O)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
WATER (UNII: 059QF0KO0R)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIACETIN (UNII: XHX3C3X673)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
Product Characteristics
ColororangeScoreno score
ShapeROUNDSize11mm
FlavorImprint Code 44;227
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0536-1232-011 in 1 CARTON06/01/2019
1100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01306/01/2019
Labeler - Rugby Laboratories (079246066)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464manufacture(0536-1232) , pack(0536-1232)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867837manufacture(0536-1232)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867894manufacture(0536-1232)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.868734088manufacture(0536-1232)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.117025878manufacture(0536-1232)

Revised: 5/2026
Document Id: 17542736-6191-4a3b-8796-5d2a806092cb
Set id: 939fce7e-55df-4dc5-916b-a533448e962f
Version: 14
Effective Time: 20260508
 
Rugby Laboratories