Label: ACETAMINOPHEN ASPIRIN CAFFEINE- acetaminophen aspirin caffeine tablet

  • NDC Code(s): 0363-9680-10, 0363-9680-24
  • Packager: WALGREEN CO
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated May 25, 2021

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

  • Active ingredients (in each caplet)

    Acetaminophen 250 mg

    Aspirin 250 mg (NSAID)**

    Caffeine 65 mg

    **nonsteroidal anti-inflammatory drug

  • Purposes

    Pain reliever

    Pain reliever

    Pain reliever aid

  • Use

    treats migraine

  • 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 severe 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 2 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

  • Medication overuse headache warning

    Headaches may worsen if this product is used for 10 or more days per month.

  • 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 occasionally rapid heart beat.

  • 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 never had migraines diagnosed by a health professional
    ■ you have a headache that is different from your usual migraines
    ■ you have the worst headache of your life
    ■ you have fever and stiff neck
    ■ you have headaches beginning after or caused by head injury, exertion, coughing or bending
    ■ you experienced your first headache after the age of 50
    ■ you have daily headaches
    ■ you have a migraine so severe as to require bed rest
    ■ 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
    ■ you have problems or serious side effects from taking pain relievers or fever reducers
    ■ you have vomiting with your migraine headache

  • Ask a doctor or pharmacist before use if you are

    ■ taking a prescription drug for:
    • diabetes • gout • arthritis
    ■ under a doctor’s care for any serious condition
    ■ taking any other drug
    ■ taking any other product that contains aspirin, acetaminophen or any other pain reliever/fever reducer

  • Stop use and ask a doctor if

    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
    ■ your migraine is not relieved or worsens after first dose
    ■ new or unexpected symptoms occur
    ■ ringing in the ears or loss of hearing occurs

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

  • Directions

    ■ do not use more than directed
    ■ adults: take 2 caplets with a glass of water
    • if symptoms persist or worsen, ask your doctor
    • do not take more than 2 caplets in 24 hours, unless directed by a doctor
    ■ under 18 years of age: ask a doctor

  • Other information

    ■ store at room temperature 20° to 25°C (68° to 77°F)
    ■ close cap tightly after use
    ■ read all product information before using.

  • Inactive ingredients

    carnauba wax, hydroxypropyl cellulose, hypromellose, microcrystalline cellulose, polyethylene glycol, sodium stearyl fumarate and titanium dioxide

  • Questions or comments?

    Contact 1-877-770-3183 Mon-Fri 8:00 AM EST to 5:00 PM PST.

  • PRINCIPAL DISPLAY PANEL

    24 count100 count

  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN ASPIRIN CAFFEINE 
    acetaminophen aspirin caffeine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-9680
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN250 mg
    CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE65 mg
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN250 mg
    Inactive Ingredients
    Ingredient NameStrength
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    HYDROXYPROPYL CELLULOSE (110000 WAMW) (UNII: 5Y0974F5PW)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)  
    HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeCAPSULE (Capsule shaped Tablet) Size17mm
    FlavorImprint Code I1
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-9680-2424 in 1 BOTTLE; Type 0: Not a Combination Product08/16/2021
    2NDC:0363-9680-10100 in 1 BOTTLE; Type 0: Not a Combination Product08/16/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21403908/16/2021
    Labeler - WALGREEN CO (008965063)