Label: EXTRA STRENGTH HEADACHE, CIRCLE K- acetaminophen/aspirin/caffeine tablet tablet
EXTRA STRENGTH HEADACHE- acetaminophen/aspirin/caffeine tablet tablet

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

Drug Label Information

Updated December 14, 2023

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

  • Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each caplet)

    Acetaminophen 250 mg

    Aspirin 250 mg (NSAID)*

    Caffeine 65 mg

    *nonsteroidal anti-inflammatory drug

  • PURPOSE

    Purposes

    Pain reliever

    Pain reliever

    Pain reliever aid

  • INDICATIONS & USAGE

    Uses

    • temporarily relieves minor aches and pains due to:
    • headache
    • a cold
    • arthritis
    • muscular aches
    • sinusitis
    • toothache
    • premenstrual and menstrual cramps
  • WARNINGS

    Reye's Syndrome

    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

    Allergy alert:Aspirin may cause a severe allergic reaction,
    which may include:

    • hives
    • facial swelling
    • asthma (wheezing)
    • shock

    Allergy Alert

    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.

    Liver Warning

    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

    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

    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 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

    • any other drug containing an NSAID (prescription or nonprescription)
    • a prescription drug for diabetes, gout, or arthritis
    • any other drug or are under a doctor’s care for any serious condition
    • a blood thinning (anticoagulant) or steroid drug

    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 appear

    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

    Overdose warning: 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.

  • DOSAGE & ADMINISTRATION

    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; do not take more than 8 caplets in 24 hours
    • children under 12 years: ask a doctor
  • Other information

    • store between 20°-25°C (68°-77°F)
  • INACTIVE INGREDIENT

    Inactive ingredients

    colloidal silicon dioxide, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone K30, pregelatinized starch, stearic acid, talc

  • QUESTIONS

    Questions or comments?
    Call toll-free 1-877-507-6516 (M-F 8AM-4:30PM CST)

  • PDP (Lil' Drug)

    [caduceus]

    Compare to the Active
    Ingredients in Excedrin®
    Extra Strength**

    Extra Strength
    Headache

    Acetaminophen 250 mg
    Pain Reliever
    Aspirin (NSAID) 250 mg Pain Reliever
    Caffeine 65 mg Pain Reliever Aid

    [caplets image]

    ACTUAL SIZE

    50

    Caplets [Lil' Drug Store Logo]

    PDP

  • PDP (CK)

    TEMPORARILY RELIEVES
    HEADACHES

    Compare to the active ingredients
    in Excedrin ® Extra Strength*

    CIRCLE K™

    extra strength
    headache

    Acetaminophen 250 mg, Pain Reliever
    Aspirin (NSAID) 250 mg, Pain Reliever
    Caffeine 65 mg, Pain Reliever Aid

    [caplet image]

    actual size

    50 caplets

    PDP

  • INGREDIENTS AND APPEARANCE
    EXTRA STRENGTH HEADACHE, CIRCLE K 
    acetaminophen/aspirin/caffeine tablet tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66715-5506(NDC:68210-4094)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN250 mg
    CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE65 mg
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN250 mg
    Inactive Ingredients
    Ingredient NameStrength
    TALC (UNII: 7SEV7J4R1U)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE K30 (UNII: U725QWY32X)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Product Characteristics
    Colorwhite (white to off-white with specs) Scoreno score
    ShapeOVAL (capsule-shaped biconvex) Size18mm
    FlavorImprint Code S53
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66715-5506-41 in 1 CARTON09/24/2021
    150 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01309/24/2021
    EXTRA STRENGTH HEADACHE 
    acetaminophen/aspirin/caffeine tablet tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66715-6922(NDC:68210-0107)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN250 mg
    CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE65 mg
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN250 mg
    Inactive Ingredients
    Ingredient NameStrength
    TALC (UNII: 7SEV7J4R1U)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE K30 (UNII: U725QWY32X)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Product Characteristics
    Colorwhite (white to off-white with specs) Scoreno score
    ShapeOVAL (capsule-shaped biconvex) Size18mm
    FlavorImprint Code S53
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66715-6922-41 in 1 CARTON09/24/2021
    150 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01309/24/2021
    Labeler - Lil' Drug Store Products, Inc. (093103646)