Label: ASPIRIN 325 MG- aspirin tablet

  • 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 February 1, 2016

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Aspirin USP, 325 mg (NSAID)*

    *nonsteroidal anti-inflammatory drug

  • PURPOSE

    Pain Reliever/Fever Reducer

  • INDICATIONS & USAGE

    temporarily relieves

    • headache
    • menstrual pain
    • minor pain of arthritis
    • muscle pain
    • toothache
    • pain and fever of colds
  • 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 prodcut, 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.

  • OTHER SAFETY INFORMATION

    Allergy alert: Aspirin may cause a severe allergic reaction which may include

    • hives
    • facial swelling
    • asthma (wheezing)
    • shock
  • OTHER SAFETY INFORMATION

    Stomach bleeding warning: This prodcut 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 NSIADs (ibuprofen, naproxen, or others)
    • take more or for a longer time than directed
    • have 3 or more alcoholic drinks every day while using this product

    Drug Facts continued on back of label

  • DO NOT USE

    Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer

  • ASK DOCTOR

    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 DOCTOR/PHARMACIST

    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

    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 lasta more than 3 days
    • redness or swelling is present in the painful area
    • any new symptoms appear
    • ringing in the ears or loss of hearing occurs

    These could be sings of a serious condition

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use. It is especially imporant 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

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control right away.

  • Directions

    DRINK A FULL GLASS OF WATER WITH EACH DOSE

    • adults and children 12 years and over: 1-2 tablets every 4 hours while symptoms last, not more than 12 tablets in 24 hours
    • children under 12 years: ask a doctor
  • Other information

    • store at room temperature 15°-30ºC (59°-86°F)
  • INACTIVE INGREDIENT

    Inactive ingredients corn starch, povidone

  • Questions or comments

    Questions or comments ? call 516-341-0666, 8:30 am - 4:30 pm ET, Monday - Friday

  • SPL UNCLASSIFIED SECTION

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

  • SPL UNCLASSIFIED SECTION

    *Reliable 1 Laboratories LLC is not affiliated with the owner of the trademark GENUINE BAYER®.

    Distributed by: Reliable 1 Laboratories LLC, Valley Stream, NY 11580

    www.reliable1labs.com

  • PRINCIPAL DISPLAY PANEL

    NDC 69618-016-01

    Aspirin USP 325 mg (NSAID)

    PAIN RELIEVER

    FEVER REDUCER

    100 TABLETS

    *Compare to Active Ingredient in GENUINE BAYER® Aspirin 325 mg

  • INGREDIENTS AND APPEARANCE
    ASPIRIN 325 MG 
    aspirin tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69618-016
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN325 mg
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    POVIDONE (UNII: FZ989GH94E)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code AP;010
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69618-016-01100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/01/2015
    2NDC:69618-016-101000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/01/2015
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34311/01/2015
    Labeler - Reliable 1 Laboratories LLC (079718111)