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

  • NDC Code(s): 58602-817-02, 58602-817-03, 58602-817-07, 58602-817-09, view more
    58602-817-14, 58602-817-21, 58602-817-34, 58602-817-36, 58602-817-38, 58602-817-90
  • Packager: Aurohealth LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated May 13, 2022

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 - 8 Tablets

    AUROHEALTH
    NDC 58602-817-02
    Acetaminophen, Aspirin (NSAID)
    and Caffeine Tablets USP
    250 mg/250 mg/65 mg


    Pain Reliever/
    Pain Reliever Aid                            8 Tablets



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

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

    AUROHEALTH
    NDC 58602-817-02
    **Compare to the active ingredients
    of Excedrin® Migraine

    Acetaminophen, Aspirin (NSAID)

    and Caffeine Tablets USP

    250 mg/250 mg/65 mg

    Do not use if seal imprinted with
    SEALED for YOUR PROTECTION under
    the bottle cap is broken or missing.

    Pain Reliever/Pain Reliever Aid                            8 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:58602-817
    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:58602-817-021 in 1 CARTON02/02/2022
    18 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:58602-817-031 in 1 CARTON02/02/2022
    210 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:58602-817-071 in 1 CARTON02/02/2022
    324 in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:58602-817-091 in 1 CARTON02/02/2022
    430 in 1 BOTTLE; Type 0: Not a Combination Product
    5NDC:58602-817-141 in 1 CARTON02/02/2022
    550 in 1 BOTTLE; Type 0: Not a Combination Product
    6NDC:58602-817-211 in 1 CARTON02/02/2022
    6100 in 1 BOTTLE; Type 0: Not a Combination Product
    7NDC:58602-817-901 in 1 CARTON02/02/2022
    7125 in 1 BOTTLE; Type 0: Not a Combination Product
    8NDC:58602-817-34200 in 1 BOTTLE; Type 0: Not a Combination Product02/02/2022
    9NDC:58602-817-36250 in 1 BOTTLE; Type 0: Not a Combination Product02/02/2022
    10NDC:58602-817-38300 in 1 BOTTLE; Type 0: Not a Combination Product02/02/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21169502/02/2022
    Labeler - Aurohealth LLC (078728447)
    Establishment
    NameAddressID/FEIBusiness Operations
    APL HEALTHCARE LIMITED650918514ANALYSIS(58602-817) , MANUFACTURE(58602-817)