Label: EXTRA STRENGTH PAIN RELIEVER- acetaminophen, aspirin, and caffeine capsule, coated

  • NDC Code(s): 73598-1372-1
  • Packager: JHK Inc dba American Safety & First Aid
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated April 25, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient (In Each Caplets)Purpose
    *
    Nonsteroidal Anti-Inflammatory Drug
    Acetaminophen 250 mgpain reliever/fever reducer
    Aspirin 250 mg (NSAID)*pain reliever/fever reducer
    Caffeine 65 mgpain reliever aid
  • Use

    temporarily relieves fever and minor aches and pains associated with:

    • headache
    • colds
    • muscular aches
    • menstrual discomfort
    • toothaches
    • minor arthritis pain
  • 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

    Liver Warning

    This product contains acetaminophen. Severe liver damage may occur if you take:

    • more than 8 tablets in 24 hours, which is the maximum daily amount
    • with other drugs containing acetaminophen
    • 3 or more alcoholic drinks every day while using this product

    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 drugs containing a prescription or nonprescription 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

    Caffeine warning

    The recommended dosage of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness and, occasionally, rapid heartbeat.

    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
    • with any other product containing acetaminophen (prescription or nonprescription).
    • If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

    Ask doctor before use if

    • stomach bleeding warning applies to you
    • you have liver disease, high blood pressure, heart disease, liver cirrhosis, asthma or kidney disease
    • you are taking diuretic
    • you have a history of stomach problems, such as heartburn

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

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

    When using this product do not exceed recommended dose.

    Stop use and ask 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 breastfeeding, ask a health professional before use. IT IS ESPECIALLY IMPORTANT NOT TO USE ASPIRIN DURING THE LAST 3 MONTHS OF PREGNANCY UNLESS SPECIFICALLY 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

    2 tablets, with water every 6 hours while symptoms persist; not to exceed 8 tablets in 24 hours or as directed by a doctor. Children under 12 years: consult a doctor.

  • Other Information

    • do not use if packet is opened or torn
    • store at room temperature 68º-77ºF (20º-25ºC)
    • avoid excessive heat and humidity
    • each caplet contains: Magnesium 0.58 mg
  • Inactive ingredient

    Colloidal Silicon Dioxide, Hypromellose, Microcrystalline Cellulose, Polyvinyl Pyrrolidone, Polyethylene Glycol, Pregelatinized Starch, Starch 1500, Stearic Acid, Talc

  • Questions?

    1-866-651-3660 Monday-Friday

    8:00am-5:00pm EST

    Manufactured for American Safety & First Aid Osceola, IN 46561

  • PRINCIPAL DISPLAY PANEL - 50 Caplet Packet Box

    This product is not manufactured or distributed by Novartis
    Owner of the registered trademark Excedrin®.

    Product #1372

    Extra Strength
    Pain Reliever

    Pain Reliever/Fever Reducer

    Active ingredient:
    Acetaminophen, Aspirin
    Caffeine

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

    These quality comfort caplets are formulated and packaged for use in the
    workplace and meet ANSI Z308. 1-2021 standards. They are sealed in
    tamper-evident packets for safety and convenience.

    50 Caplets • 2 Caplets Per Packet

    PRINCIPAL DISPLAY PANEL - 50 Caplet Packet Box
  • INGREDIENTS AND APPEARANCE
    EXTRA STRENGTH PAIN RELIEVER 
    acetaminophen, aspirin, and caffeine capsule, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73598-1372
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN250 mg
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN250 mg
    CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE65 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeRECTANGLESize18mm
    FlavorImprint Code S53
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73598-1372-125 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)