Label: EXTRA STRENGTH HEADACHE RELIEF- acetaminophen, aspirin, and caffeine tablet, coated

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

Drug Label Information

Updated December 31, 2024

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

  • Drug Facts

  • 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

  • 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 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 sever 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 no prescription 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 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 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
    • a prescription drug for diabetes, gout, or arthritis
    • 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 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 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.
    Overdose warning: Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away

  • Directions

    do not use more than directed (see overdose warning)
    • 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

    each tablet contains: sodium 5.1mg (low sodium)
    • store at room temperature between 20-25C (68 to 77F)
    • avoid excessive heat, cold and humidity
    • close cap tightly after use
    • read all products information before using.

  • Inactive ingredients

    croscarmellose sodium, magnesium stearate, microcrystalline cellulose, polacrilin potassium, polyethylene glycol, polyvinyl alcohol, povidone, purified talc, sodium lauryl sulphate, sodium starch glycolate, starch, titanium dioxide

  • Questions or comments?

    1-888-577-8033 Monday-Friday 8am-4pm

  • SPL UNCLASSIFIED SECTION

    DG™ health

    Compare to the active ingredients of Excedrin® Extra Strength††

    READ AND KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

    TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

    ++ This product is not manufactured or distributed by GSK Consumer Healthcare, distributor of Excedrin® Extra Strength.

    DISTRIBUTED BY OLD EAST MAIN CO.
    100 MISSION RIDGE
    GOODLETTSVILLE, TN 37072

    MADE IN INDIA

    100%
    Satisfaction Guaranteed!
    (888) 309-9030

  • Packaging

    Extra Strength Headache Relief

  • INGREDIENTS AND APPEARANCE
    EXTRA STRENGTH HEADACHE RELIEF 
    acetaminophen, aspirin, and caffeine tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55910-440
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN250 mg
    ASPIRIN (UNII: R16CO5Y76E) (ACETYLSALICYLIC ACID - UNII:R16CO5Y76E) ASPIRIN250 mg
    CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE65 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLACRILIN POTASSIUM (UNII: 0BZ5A00FQU)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    TALC (UNII: 7SEV7J4R1U)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeOVALSize18mm
    FlavorImprint Code S142
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55910-440-011 in 1 CARTON05/01/2021
    1100 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01305/01/2021
    Labeler - Dollar General (068331990)