Label: ASPIRIN REGULAR STRENGTH- aspirin tablet, delayed release
- NDC Code(s): 0536-1232-01
- Packager: Rugby Laboratories
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated May 8, 2026
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Active ingredient (in each tablet)
- Purpose
- Uses
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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:
- hives
- facial swelling
- asthma (wheezing)
- shock
Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you
- are age 60 or older
- have had stomach ulcers or bleeding problems
- take a blood thinning (anticoagulant) or steroid drug
- take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
- have 3 or more alcoholic drinks every day while using this product
- take more or for a longer time than directed
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
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Directions
- do not take more than directed
- drink a full glass of water with each dose
- adults and children 12 years and over: take 1 to 2 tablets every 4 hours while symptoms last
- do not take more than 12 tablets in 24 hours unless directed by a doctor
- children under 12 years: do not use unless directed by a doctor
- Other information
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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?
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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 pain100 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 ORG032522712Distributed by:
RUGBY® LABORATORIES
Indianapolis, IN 46268
(800) 616-2471
www.major-rugby.com
Rugby 44-227A
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INGREDIENTS AND APPEARANCE
ASPIRIN REGULAR STRENGTH
aspirin tablet, delayed releaseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0536-1232 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 325 mg Inactive Ingredients Ingredient Name Strength 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 Color orange Score no score Shape ROUND Size 11mm Flavor Imprint Code 44;227 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0536-1232-01 1 in 1 CARTON 06/01/2019 1 100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M013 06/01/2019 Labeler - Rugby Laboratories (079246066) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 038154464 manufacture(0536-1232) , pack(0536-1232) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867837 manufacture(0536-1232) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867894 manufacture(0536-1232) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 868734088 manufacture(0536-1232) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 117025878 manufacture(0536-1232)
