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 April 10, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- 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:
- facial swelling
- hives
- shock
- asthma (wheezing)
Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you
- take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
- are age 60 or older
- have had stomach ulcers or bleeding problems
- take a blood thinning (anticoagulant) or steroid drug
- take more or for a longer time than directed
- have 3 or more alcoholic drinks every day while using this product
Do not use
- if you are allergic to aspirin or any other pain reliever/fever reducer
- if you have ever had an allergic reaction to this product or any of its ingredients
Ask a doctor before use if
- stomach bleeding warning applies to you
- you have a history of stomach problems, such as heartburn
- you are taking a diuretic
- you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
- you have asthma
Ask a doctor or pharmacist before use if you are
taking a prescription drug for
- diabetes
- arthritis
- gout
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:
- vomit blood
- feel faint
- have bloody or black stools
- have stomach pain that does not get better
- ringing in the ears or a loss of hearing occurs
- new symptoms occur
- pain gets worse or lasts more than 10 days
- fever gets worse or lasts more than 3 days
- redness or swelling is present
These could be signs of a serious condition.
- Directions
- Other information
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Inactive ingredients
black iron oxide, cellulose, colloidal anhydrous silica, corn starch, D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, polydextrose, polyethylene glycol, polyvinyl acetate phthalate, propylene glycol, shellac wax, simethicone, sodium alginate, sodium bicarbonate, stearic acid, 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
325 mg
Pain Reliever (NSAID)
Safety Coated
Aspirin Regimen††100 Enteric Coated Tablets
Actual Size
TAMPER EVIDENT: DO NOT USE IF IMPRINTED
SAFETY SEAL UNDER CAP IS BROKEN OR MISSING††Talk to your doctor or other healthcare provider before using
this product for your heart.†This product is not manufactured or distributed by Medtech
Products Inc., owner of the registered trademark Ecotrin®
Regular Strength. 50844 REV0122B22712Distributed by: RUGBY® LABORATORIES, Livonia, MI 48152
www.rugbylaboratories.com
Rugby 44-227
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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) STARCH, CORN (UNII: O8232NY3SJ) D&C YELLOW NO. 10 ALUMINUM LAKE (UNII: CQ3XH3DET6) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) POLYDEXTROSE (UNII: VH2XOU12IE) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) Polyvinyl Acetate Phthalate (UNII: 58QVG85GW3) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHELLAC (UNII: 46N107B71O) DIMETHICONE (UNII: 92RU3N3Y1O) WATER (UNII: 059QF0KO0R) SODIUM ALGINATE (UNII: C269C4G2ZQ) SODIUM BICARBONATE (UNII: 8MDF5V39QO) STEARIC ACID (UNII: 4ELV7Z65AP) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TRIACETIN (UNII: XHX3C3X673) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) Product Characteristics Color orange Score no score Shape ROUND Size 10mm 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. 967626305 pack(0536-1232) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 117025878 manufacture(0536-1232)