Label: ASPIRIN 50 CT- aspirin tablet

  • NDC Code(s): 73598-1112-1
  • Packager: JHK Inc dba American Safety & First Aid
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated April 26, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (In Each Tablets)

    Aspirin 325 mg

  • Purpose

    pain reliever/fever reducer

  • Use

    temporarily relieves fever and minor aches and pains associated with:

    • headache
    • colds
    • muscular aches
    • toothache
    • minor arthritis pain
    • menstrual cramps
  • 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 Warning

    Aspirin may cause a severe allergic reaction which may include:

    • hives
    • facial swelling
    • asthma (wheezing)
    • shock

    Stomach bleeding warning

    This product contains a nonsteroidal anti-inflammatory drug (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 prescription or nonprescription drugs containing an NSAID (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
    • with any other pain reliever/fever reducer
    • if you have ever had an allergic reaction to any other pain reliever/fever reducer
    • for pain for more than 10 days or for fever for more than 3 days unless directed by a 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 a history of stomach problems, such as heartburn

    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 lasts more than 3 days
    • redness or swelling is present in the painful area
    • any new symptoms appear

    Ask a doctor or pharmacist before use if you are taking a prescription drug for:

    • anticoagulation (thinning of the blood)
    • diabetes
    • gout
    • arthritis

    When using this product do not exceed recommended dose.

    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
    • ringing in the ears or loss of hearing occurs
    • pain or fever persists or gets worse
    • new symptoms occur
    • redness or swelling is present

    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. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • Directions

    Adults and children 12 years of age and older: Take 2 tablets with water every 4 hours as needed, not to exceed 12 tablets in 24 hours, or as directed by doctor Children under 12 years of age: Ask a doctor.

  • Other Information

    • do not use if packet is opened or torn
    • Store at 20-25°C (68-77°F) avoid excessive heat above 40°C (104°F)
  • Inactive Ingredients

    microcrytalline cellulose, povidone, pregelatinized starch

  • Questions?

    1-866-651-3660 Monday-Friday 8:00am-5:00pm EST

  • PRINCIPAL DISPLAY PANEL - 50 Tablet Packet Box

    Product #1112

    Aspirin

    Pain Reliever/Fever Reducer (NSAID)

    • Temporary relief from pain and fever
    • Soothes muscle aches and minor
      arthritis pain

    These quality comfort tablets are formulated and packaged for use in
    the workplace and meet ANSI Z308.1-2015 standards. They are
    sealed in tamper-evident packets for safety and convenience.

    50 Tablets • 2 Tablets Per Packet

    Manufactured for American Safety & First Aid
    Osceola, IN 46561

    PRINCIPAL DISPLAY PANEL - 50 Tablet Packet Box
  • INGREDIENTS AND APPEARANCE
    ASPIRIN 50 CT 
    aspirin tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73598-1112
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN325 mg
    Inactive Ingredients
    Ingredient NameStrength
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeROUNDSize12mm
    FlavorImprint Code ASPIRIN;44;157
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73598-1112-125 in 1 BOX02/02/2000
    12 in 1 DOSE PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph drugM01302/02/2000
    Labeler - JHK Inc dba American Safety & First Aid (867236309)