Label: ASPIRIN REGULAR STRENGTH- aspirin tablet, coated

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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.

Drug Label Information

Updated June 23, 2021

If you are a consumer or patient please visit this version.

  • Active ingredient (in each tablet)

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

  • Purpose

    Pain reliever

  • Uses

    • temporarily relieves minor aches and pains due to:
      • headache
      • menstrual pain
      • a cold
      • toothache
      • muscle pain
      • minor pain of arthritis
    • or as recommended by your doctor
  • 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 have asthma
    • you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
    • you are taking a diuretic

    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
    • redness or swelling is present

    These could be signs of a serious condition.

    If pregnant or breast-feeding,

    ask a health professional before use. It is especially important not to use aspirin during the last 3 months of 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 (1-800-222-1222) right away.

  • 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 not to exceed 12 tablets in 24 hours unless directed by a doctor
    • children under 12 years: do not use unless directed by a doctor
  • Other information

    • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
    • see end flap for expiration date and lot number
  • 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?

    1-800-645-2158

  • 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         REV0421A22712

    Distributed by: RUGBY® LABORATORIES,
    Livonia, MI 48152
    www.rugbylaboratories.com

    Rugby 44-227

    Rugby 44-227

  • INGREDIENTS AND APPEARANCE
    ASPIRIN  REGULAR STRENGTH
    aspirin tablet, coated
    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)  
    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)  
    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)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    WATER (UNII: 059QF0KO0R)  
    POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
    Product Characteristics
    ColororangeScoreno score
    ShapeROUNDSize10mm
    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 not finalpart34306/01/2019
    Labeler - Rugby Laboratories (079246066)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.868734088manufacture(0536-1232) , pack(0536-1232)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867894manufacture(0536-1232)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464pack(0536-1232)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305pack(0536-1232)