Label: ACETAMINOPHEN ASPIRIN AND CAFFEINE- acetaminophen, aspirin and caffeine tablet, film coated

  • NDC Code(s): 58602-882-21, 58602-882-38
  • Packager: Aurohealth LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated December 1, 2023

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

  • Drug Facts

    Active ingredients (in each tablet)

    Acetaminophen USP 250 mg

    Aspirin USP 250 mg (NSAID*)

    Caffeine USP 65 mg

    *nonsteroidal anti-inflammatory drug

  • Purposes

    Pain reliever
    Pain reliever
    Pain reliever aid

  • Use

    treats migraine

  • 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 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 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 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

    • 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 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 right away (1-800-222-1222). 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 tablets with a glass of water
    • if symptoms persist or worsen, ask your doctor
    • do not take more than 2 tablets in 24 hours, unless directed by a doctor
    • under 18 years of age: ask a doctor
  • Other information

    • store at controlled room temperature 20°-25°C (68°-77°F)
    • close cap tightly after use
    • read all product information before using. Keep this box for important information.
  • Inactive ingredients

    crospovidone, glyceryl monostearate, low-substituted hydroxypropyl cellulose, microcrystalline cellulose, polyvinyl alcohol, povidone, pregelatinized starch (maize), sodium lauryl sulfate, stearic acid, talc and  titanium dioxide.

  • Questions or comments?

    call 1-855-274-4122 (Monday – Friday 8:30 AM to 5:00 PM EST)

    Distributed by:
    AUROHEALTH LLC
    279 Princeton-Hightstown Road,
    East Windsor, NJ 08520

    Made in India

    Code: AP/DRUGS/04/2016

  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 250 mg/250 mg/65 mg Container Label - 100 Tablets

    Healthy Living

    ACETAMINOPHEN,
    ASPIRIN (NSAID)
    AND CAFFEINE
    tablets USP, 250 mg/250 mg/65 mg

    Pain Reliever/Pain Reliever Aid
    100 Tablets

    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 250 mg/250 mg/65 mg Container Label - 100 Tablets

  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 250 mg/250 mg/65 mg Container Carton Label - 100 Tablets

    Healthy Living
    ACETAMINOPHEN, ASPIRIN (NSAID)
    AND CAFFEINE
    tablets USP, 250 mg/250 mg/65 mg

    **Compare
    to the Active
    Ingredients of
    Excedrin®
    Migraine

    Pain Reliever/Pain Reliever Aid                            100 Tablets


    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 250 mg/250 mg/65 mg Container Carton Label - 8 Tablets

  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN ASPIRIN AND CAFFEINE 
    acetaminophen, aspirin and caffeine tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58602-882
    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
    CROSPOVIDONE (120 .MU.M) (UNII: 68401960MK)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 2165RE0K14)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    POVIDONE K30 (UNII: U725QWY32X)  
    POVIDONE K90 (UNII: RDH86HJV5Z)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorWHITE (White to off-White) Scoreno score
    ShapeCAPSULE (biconvex) Size18mm
    FlavorImprint Code T;57
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58602-882-211 in 1 CARTON06/23/2022
    1100 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:58602-882-381 in 1 CARTON06/23/2022
    2300 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21169506/23/2022
    Labeler - Aurohealth LLC (078728447)
    Establishment
    NameAddressID/FEIBusiness Operations
    APL HEALTHCARE LIMITED650918514ANALYSIS(58602-882) , MANUFACTURE(58602-882)