Label: ASPIRIN REGULAR STRENGTH- aspirin 325mg tablet

  • NDC Code(s): 73057-365-08, 73057-365-11
  • Packager: Ulai Health LLC
  • Category: HUMAN OTC DRUG LABEL

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 January 31, 2022

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  • Active Ingredient (in each tablet)

    Aspirin 325mg (NSAID) †

    †nonsteroidal anti-inflammatory drug

  • Purpose

    Pain reliever/fever reducer

  • Uses

    • temporarily relieves minor aches and pains due to:
    • headache
    • muscle pain
    • toothache
    • menstrual pain
    • colds
    • minor pains of arthritis
    • temporarily reduces fever
  • 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
    • if you have ever had an allergic reaction to this product or any of its ingredients

    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

    • gout
    • diabetes
    • 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 more than 10 days
    • fever gets worse or lasts more than 3 days
    • redness or swelling is present
    • ringing in the ears or loss of hearing occurs
    • new symptoms occur

    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 (1-800-222-1222).

  • Directions

    • drink a full glass of water with each dose
     adults and children 12 years and over take 1 to 2 tablets every 4 hours or 3 tablets every 6 hours, not to exceed 12 tablets in 24 hours
     children under 12 years ask a doctor

  • Other information

    • store at 20-25°C (68-77°F)
    • avoid excess heat and moisture
  • Inactive ingredient

    corn starch

  • Questions or comments?

    (866) 562-2756 (Mon- Fri 8 AM to 4 PM EST)

  • PRINCIPAL DISPLAY PANEL

    PHARBEST

    NDC 73057-365-11

    Manufactured in the USA

    *Compare to the active ingredient in Genuine Bayer ® Aspirin

    Aspirin

    Regular Strength

    Pain Reliever/Fever Reducer (NSAID)

    1000 TABLETS

    Aspirin, 325 mg each

    Aspirin 325 mg Tablet

  • INGREDIENTS AND APPEARANCE
    ASPIRIN REGULAR STRENGTH 
    aspirin 325mg tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73057-365
    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)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUND (ROUND TABLET) Size10mm
    FlavorImprint Code PH033
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73057-365-111000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/28/2019
    2NDC:73057-365-08100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/28/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34306/28/2019
    Labeler - Ulai Health LLC (081181535)
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