Label: ASPIRIN 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 February 17, 2011

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

  • Active ingredient

    Aspirin 325mg

  • Purpose

    Pain Reliever

  • Keep Out of Reach of Children

    In case of overdose, get medical help or contact a Poison Control Center right away.

  • Uses

    For the temporary relief of minor aches and pains. Ask your doctor about other uses for 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 or 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) or 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 ° the stomach bleeding warning applies to you ° you are taking a diuretic ° you have a history of stomach problems such as heartburn ° you have high blood pressure, heart disease, liver cirrhosis, kidney disease or asthma.

    Ask a doctor or pharmacist before use if you are ° taking any other drug containing an NSAID (prescription or nonprescription) ° taking a blood thinning (anticoagulant) or steroid drug ° taking a prescription drug for diabetes, gout or arthritis.

    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, an allergic reaction occurs. Seek medical help right away if pain gets worse or lasts more than 10 days, redness or swelling is present, fever gets worse or lasts more than 3 days, any new symptoms occur, or 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.

  • Directions

    Drink a full glass of water with each dose. Swallow whole; do not chew or crush. Do not exceed recommend dose.

    Adults and children 12 years and older: take 1-2 tablets every 4 hours, as needed, not more than 12 tablets in 24 hours, or as directed by a doctor.

    Children under 12: ask a doctor.

  • Other Information

    Store at room temperature, 15°C - 30°C (59°F - 86°F).

    For institutional use only.

  • Inactive ingredients

    May contain acetylated monoglycerides, cellulose, croscarmellose sodium, D&C yellow no. 10, FD&C yellow no. 6, hypromellose, hypromellose phthalate, iron oxide, methacrylic acid, mineral oil, PEG, polydextrose, polysorbate 80, polyvinyl acetate phthalate, propylene glycol, silica sodium alginate, sodium bicarbonate, sodium lauryl sulfate, starch stearic acid, talc, titanium dioxide, triacetin, triethyl citrate, wax.

  • Package/Label Principal Display Panel

    Aspirin EC 325mg

  • INGREDIENTS AND APPEARANCE
    ASPIRIN 
    aspirin tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21695-666(NDC:57896-401)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN325 mg
    Inactive Ingredients
    Ingredient NameStrength
    CELLULOSE ACETATE (UNII: 3J2P07GVB6)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    HYPROMELLOSE PHTHALATE (24% PHTHALATE, 55 CST) (UNII: 87Y6436BKR)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    METHACRYLIC ACID (UNII: 1CS02G8656)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    POLYDEXTROSE (UNII: VH2XOU12IE)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM ALGINATE (UNII: C269C4G2ZQ)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIACETIN (UNII: XHX3C3X673)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    Product Characteristics
    ColorORANGEScoreno score
    ShapeROUNDSize12mm
    FlavorImprint Code T
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:21695-666-3030 in 1 BOTTLE
    2NDC:21695-666-9090 in 1 BOTTLE
    3NDC:21695-666-00100 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34311/07/2008
    Labeler - Rebel Distributors Corp (118802834)
    Establishment
    NameAddressID/FEIBusiness Operations
    Rebel Distributors Corp118802834RELABEL, REPACK