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 18, 2018

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/ Fever Reducer

  • Uses

    temporarily relieves

    • headache
    • menstrual pain
    • muscle pain
    • toothache
    • minor pain or arthritis
    • 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 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
    • asthma (wheezing)
    • shock
    • facial swelling

      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
    • takes other drugs containing prescription or nonprescription NSAIDs (ibuprofen, naproxen, others)
    • takes 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 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 a history of stomach problems, such as heartburn
    • you have high blood pressure, heart disease, lever 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
    • taking any other drug
    • under a doctor’s care for any serious condition

      Stop use and ask a doctor if

    • you experiences 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 new symptoms appear
    • ringing in the ears or a 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 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, but not more than 12 tablets in 24 hours.
    • Children under 12 years: ask a doctor
  • Other Information

    • avoid excessive heat or humidity
    • store at 15-30 °C (59-86 °F)
  • Inactive Ingredients

    croscarmellose sodium, D&C Yellow #10 (Al-Lake), FD&C yellow #6 (Al-Lake), HPMC, methacrylic acid copolymer, polyethylene glycol, propylene glycol, PVP,  sodium lauryl sulfate, starch, stearic acid, talc, titanium dioxide

  • Questions or Comments

    Call 631-981-4600, 8.30am – 4.30 pm ET Monday-Friday

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

    Manufactured by: Advance Pharmaceutical, Inc. Holtsville, NY 11742

  • Repackaging Information

    Please reference the How Supplied section listed above for a description of individual tablets. This drug product has been received by Aphena Pharma - TN in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below:

    Count325mg
    10071610-034-65

    Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children.

    Repackaged by:
    Aphena Pharma Solutions - TN
    Cookeville, TN 38506

    20180218JH

  • PRINCIPAL DISPLAY PANEL - 325mg

    NDC 71610-034 - Aspirin EC (NSAID) 325mg - Rx Only
    Bottle Label 325mg

  • INGREDIENTS AND APPEARANCE
    ASPIRIN 
    aspirin tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71610-034(NDC:54738-111)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN325 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    METHACRYLIC ACID (UNII: 1CS02G8656)  
    POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    POVIDONE (UNII: FZ989GH94E)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    Product Characteristics
    ColororangeScoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code AP;011
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71610-034-65100 in 1 BOTTLE; Type 0: Not a Combination Product01/26/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34305/01/2015
    Labeler - Aphena Pharma Solutions - Tennessee, LLC (128385585)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aphena Pharma Solutions - Tennessee, LLC128385585REPACK(71610-034)