Label: CHRONIC PAIN/FEVER RELIEF- aspirin delayed release tablets, 81 mg tablet

  • 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 March 1, 2016

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

     
     Active Ingredient (in each tablet) Purpose
      
      Aspirin 81 mg (NSAID*) Pain reliever
     *nonsteroidal anti-inflammatory drug 

     

  • Uses

    • for the temporary relief of minor aches and pains or as recommended by your doctor. Because of its delayed action, this product will not provide fast relief of headaches or other symptoms needing immediate relief.
    • ask your doctor about other uses for 81 mg Aspirin
  • 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

    Do not use

    • if you are allergic to aspirin or 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, or 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
      • pain gets worse or lasts for more than 10 days
      • redness or swelling is present
      • any new symptoms occur
      • 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 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. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • Directions

    • drink a full glass of water with each dose
    • adults and children 12 years and over: take 4 to 8 tablets every 4 hours; not to exceed 48 tablets in 24 hours unless directed by a doctor
    • children under 12 years: consult a doctor
  • Other information

    • store at room temperature

    • read all product information before using. Keep this box for important information
  • Inactive ingredients

    Anhydrous Lactose, Carnuba Wax Colloidal Sillicon Dioxide, Crosscarmellose Sodium,FD&C Yellow #10 al lake, FD&C Yellow#6 al Lake, Iron Oxide Ochre, Methacrylic acid copolymer, Micro crystalline cellulose, Polysorbate 80, simethiocone, sodium hydroxide, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate

  • Questions or comments?

    1-888-705-WECARE (Mon-Fri 9am-5pm EST) or www.wecaredistributor.com

  • PRINCIPAL DISPLAY PANEL

    See New Warnings Information & Directions

    Compare to the Active Ingredients in
    Bayer Low Dose

    Aspirin Delayed Release Tablets, 81 mg

    TO OPEN
    PUSH IN TAB AND PULL OUT

    25 Pouches of 2 Caplets Each

    Principal Display Panel - 50 Pouch Box

  • INGREDIENTS AND APPEARANCE
    CHRONIC PAIN/FEVER RELIEF 
    aspirin delayed release tablets, 81 mg tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70005-002
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Aspirin (UNII: R16CO5Y76E) (Aspirin - UNII:R16CO5Y76E) Aspirin81 mg
    Inactive Ingredients
    Ingredient NameStrength
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    BROWN IRON OXIDE (UNII: 1N032N7MFO)  
    METHACRYLIC ACID (UNII: 1CS02G8656)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TALC (UNII: 7SEV7J4R1U)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    Product Characteristics
    ColoryellowScoreno score
    ShapeROUNDSize7mm
    FlavorImprint Code A
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70005-002-2525 in 1 BOX
    12 in 1 POUCH; Type 0: Not a Combination Product
    2NDC:70005-002-5050 in 1 BOX
    22 in 1 POUCH; Type 0: Not a Combination Product
    3NDC:70005-002-022 in 1 POUCH
    32 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34302/09/2016
    Labeler - We Care Distributor Inc. (079832998)
    Establishment
    NameAddressID/FEIBusiness Operations
    Elysium Pharmaceutical Ltd.915664486manufacture(70005-002)