Label: PHARBEST REGULAR STRENGTH ASPIRIN- aspirin tablet

  • NDC Code(s): 16103-365-08, 16103-365-11
  • Packager: Pharbest Pharmaceuticals, Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 31, 2024

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

  • 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 or 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 20-250C (68-770F)
    • 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 16103-365-11

    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

    Regular strength Aspirin 325mg tablet Product Label

  • INGREDIENTS AND APPEARANCE
    PHARBEST REGULAR STRENGTH ASPIRIN 
    aspirin tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:16103-365
    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:16103-365-081 in 1 CARTON01/12/2007
    1100 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:16103-365-111000 in 1 BOTTLE; Type 0: Not a Combination Product01/12/2007
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01301/12/2007
    Labeler - Pharbest Pharmaceuticals, Inc (557054835)
    Registrant - Pharbest Pharmaceuticals, Inc (557054835)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharbest Pharmaceuticals, Inc557054835analysis(16103-365) , manufacture(16103-365) , label(16103-365) , pack(16103-365)