Label: ASPIRIN - aspirin tablet

  • NDC Code(s): 0536-3086-10, 0536-3086-41
  • Packager: Rugby Laboratories Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 December 6, 2012

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

  • Active Ingredient

    (in each tablet)

    Aspirin 81 mg

    Close
  • Purpose

    Pain Reliever

    Close
  • Uses

    • Temporarily relieves minor aches and pains
    • For other uses, see your doctor, but do not use for more than 10 days without consulting your doctor because serious side effects may occur.
    Close
  • 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 signs 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 chances 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 non-prescription NSAIDs (ibuprofen, naproxen, or others)
    • take more or for longer time than directed
    • have 3 or more alcoholic drinks every day while using this product

      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 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 or arthritis
    • under a doctor’s care for any serious condition
    • taking any other drug

      Stop use and ask a doctor if

    • 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
    • pain gets worse or lasts more than 10 days
    • fever gets worse or lasts more than 3 days
    • redness or swelling is present in the painful area
    • any symptoms appear
    • ringing in the ears or loss of hearing occurs

      If pregnant or breast feeding,  ask a health professional before use. It is especially important not to use aspirin during the last three months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complication during delivery.

      Keep out of reach of children. In case of overdose, get medical help or contact a poison control center right away.

    Close
  • Directions

    DRINK A FULL GLASS OF WATER WITH EACH DOSE

    • adults and children 12 years & older: take 4 or 8 tablets every 4 hours while symptoms last, but not more than 48 tablets in 24 hours
    • children under 12 years: ask a doctor
    Close
  • Other Information

    • store at room temperature 15°-30°C (59°-86°F)
    Close
  • Inactive Ingredients

    croscarmellose sodium, D&C Yellow # 10 (AL-lake), HPMC, methacrylic acid copolymer, microcrystalline cellulose, polyethylene glycol/propylene glycol, PVP, silicon dioxide, sodium lauryl sulfate, corn starch, stearic acid, talc, titanium dioxide

    Close
  • Questions or Comments

    Call 1-800-645-2158, 9am–5pm ET, Monday - Friday

    Close
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

    C:\Users\advance\Desktop\word docs - rugby\aspirin-81mg-120ct\figure-1.png

    C:\Users\advance\Desktop\word docs - rugby\aspirin-81mg-120ct\figure-2.png

    NDC 0536-3086-41

    Rugby

    Enteric Coated

    Aspirin 81 mg Tablets (NSAID)
    Analgesic

    120 Tablets

    C:\Users\advance\Desktop\word docs - rugby\aspirin-81mg-120ct\Figure-3.png

    NDC 0536-3086-10

    Rugby

    Enteric Coated

    Aspirin 81 mg Tablets (NSAID)
    Analgesic

    1000 Tablets

    Close
  • INGREDIENTS AND APPEARANCE
    ASPIRIN 
    aspirin tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0536-3086
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 81 mg
    Inactive Ingredients
    Ingredient Name Strength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    POVIDONE K30 (UNII: U725QWY32X)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Color YELLOW Score no score
    Shape ROUND Size 8mm
    Flavor Imprint Code AP;121
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0536-3086-41 120 in 1 BOTTLE
    2 NDC:0536-3086-10 1000 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part343 04/28/2008
    Labeler - Rugby Laboratories Inc. (191427277)
    Registrant - Advance Pharmaceutical Inc. (078301063)
    Establishment
    Name Address ID/FEI Business Operations
    Advance Pharmaceutical Inc. 078301063 MANUFACTURE(0536-3086)
    Close