Label: ASPIRIN 325 MG EC- aspirin tablet

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated January 1, 2024

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  • 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 NSAIDs (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 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, 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 ingredients

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

  • 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 Ecotrin®.

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

    Repackaged by: Proficient Rx LP Thousand Oaks, CA 91320

    www.reliable1labs.com

  • PRINCIPAL DISPLAY PANEL

    71205-318-60NDC 71205-318-60

    Enteric Coated

    Aspirin USP 325 mg (NSAID)

    PAIN RELIEVER

    FEVER REDUCER

    60 TABLETS

    *Compare to Active Ingredients in Ecotrin®

  • INGREDIENTS AND APPEARANCE
    ASPIRIN 325 MG EC 
    aspirin tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71205-318(NDC:69618-015)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN325 mg
    Inactive Ingredients
    Ingredient NameStrength
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    METHACRYLIC ACID (UNII: 1CS02G8656)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TALC (UNII: 7SEV7J4R1U)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)  
    Product Characteristics
    ColororangeScoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code AP;110
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71205-318-2020 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/01/2022
    2NDC:71205-318-3030 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/01/2019
    3NDC:71205-318-6060 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/01/2019
    4NDC:71205-318-9090 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/01/2019
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01311/01/2015
    Labeler - Proficient Rx LP (079196022)
    Establishment
    NameAddressID/FEIBusiness Operations
    Proficient Rx LP079196022REPACK(71205-318) , RELABEL(71205-318)
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