Label: ACETAMINOPHEN, ASPIRIN, AND CAFFEINE tablet

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 1, 2025

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

  • Drug Facts

  • Active ingredients (in each geltab)

    Acetaminophen 250 mg

    Aspirin 250 mg (NSAID)**

    Caffeine 65 mg

    **nonsteroidal anti-inflammatory drug

  • Purposes

    Pain reliever

    Pain reliever

    Pain reliever aid

  • Uses

    Temporarily relieves minor aches and pains due to:

    • headache

    • a cold

    • arthritis

    • muscular aches

    • toothache

    • premenstrual & 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 alert:Acetaminophen may cause skin reactions. Symptoms may include: • skin reddening • blisters • rash
    If a skin reaction occurs, stop use and seek medical help right away.

    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 caplets 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 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

    Caffeine warning:The recommended dose 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 occasional rapid heartbeat.

    Do not use• if you have ever had an allergic reaction to acetaminophen, aspirin or any other pain reliever/fever reducer
    • with any other drug containing acetaminophen (prescription or nonprescription). if you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

    Ask a doctor before use if • you have liver disease • 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 aa prescription drug for diabetes, gout, or arthritis
    • taking any other drug, or are under a doctor's care for any serious condition

    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
    • ringing in the ears or loss of hearing occurs
    • painful area is red or swollen
    • pain gets worse or lasts for more than 10 days
    • fever gets worse or lasts for more than 3 days
    • any new symptoms occur
    These could be signs of a serious condition.

    If pregnant or breast-feeding, ask a health professional before use.
    It is especially important not to use aspirin at 20 weeks or later in 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 (1-800-222-1222)right away. Quick medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.

  • Directions

    •  do not use more than directed
    • drink a full glass of water with each dose
    adults and children 12 years and over:take 2 caplets every 6 hours; not more than 8 caplets in 24 hours
    •  children under 12 years:ask a doctor

  • Other information

    • store at 20°-25°C(68°-77°F)
    • close cap tightly after use
    • DO NOT USE IF PRINTED SEAL UNDER CAP IS MISSING OR DAMAGED
  • Inactive ingredients

    colloidal silicon dioxide, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, PVPK-30, sodium starch glycolate, stearic acid, talc, titanium dioxide.

  • Questions?

    call toll-free 1-844-912-4012

  • PRINCIPAL DISPLAY PANEL-100 Count

    NDC 37835-531-01

    Compare to the active ingredients in Excedrin® Extra Strength*

    Extra Strength

    Acetaminophen, Aspirin (NSAID)**, and Caffeine

    Pain Reliever/ Pain Reliever Aid

    100 Caplets

    *This product is not manufactured or distributed by the owner of the registered trademark Excedrin ®Extra Strength.

    Distributed by:

    BI-MART

    Eugene, OR 97402

    label

  • PRINCIPAL DISPLAY PANEL-250 Count

    NDC 37835-531-25

    Compare to the active ingredients in Excedrin® Extra Strength*

    Extra Strength

    Acetaminophen, Aspirin (NSAID)**, and Caffeine

    Pain Reliever/ Pain Reliever Aid

    250 Caplets

    *This product is not manufactured or distributed by the owner of the registered trademark Excedrin ®Extra Strength.

    Distributed by:

    BI-MART

    Eugene, OR 97402

    label

  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN, ASPIRIN, AND CAFFEINE 
    acetaminophen, aspirin, and caffeine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37835-531
    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)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    POVIDONE K30 (UNII: U725QWY32X)  
    SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeOVALSize17mm
    FlavorImprint Code HH6
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37835-531-01100 in 1 BOTTLE; Type 0: Not a Combination Product02/01/2025
    2NDC:37835-531-25250 in 1 BOTTLE; Type 0: Not a Combination Product02/01/2025
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01302/01/2025
    Labeler - Bi-Mart (027630078)
    Establishment
    NameAddressID/FEIBusiness Operations
    Health Pharma USA LLC080804485manufacture(37835-531)