Label: CIRCLE K HEADACHE RELIEF- acetaminophen, aspirin, and caffeine tablet


DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated October 15, 2014

If you are a healthcare professional or from the pharmaceutical industry please visit this version.


    Drug Facts


    Active ingredients (in each tablet) Purpose
    nonsteroidal anti-inflammatory drug
    Acetaminophen 250 mg Pain reliever
    Aspirin 250 mg (NSAID*) Pain reliever
    Caffeine 65 mg Pain reliever aid
  • Uses

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

    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 4,000 mg of acetaminophen in 24 hours
    • 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

    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 liver disease
    • the 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 blood thinning (anticoagulant) drug such as warfarin
    • a steroid drug
    • a prescription drug for diabetes, gout, or arthritis
    • any other drug, or are under a doctor's care for any serious condition

    When using this product

    • take with food or milk if stomach upset occurs

    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

    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. (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
    • drink a full glass of water with each dose
    • adults and children 12 years and over
    take 2 tablets every 6 hours; not more than 8 tablets in 24 hours.
    • children under 12 years
    ask a doctor
  • Other information

    • do not use if carton or pouch is open or damaged
    • store at room temperature 59-86°F (15-30°C)
    • avoid excessive heat and humidity
    • see bottom panel of carton or pouch for expiration date and lot number
  • Inactive ingredients

    hypromellose, maltodextrin, microcrystalline cellulose, polyethylene glycol, povidone, sodium starch glycolate, starch, stearic acid, titanium dioxide

  • Questions or comments?

    call toll-free 1-877-507-6516 (M-F 8 AM-4:30PM CST)


    Proudly distributed by Circle K Stores Inc.

  • PRINCIPAL DISPLAY PANEL - 2 Tablet Pouch Carton

    Compare to the Active
    Ingredients in Excedrin®*



    Acetaminophen, Aspirin (NSAID) and Caffeine
    Pain Reliever/Pain Reliever Aid



    2 Tablets

    PRINCIPAL DISPLAY PANEL - 2 Tablet Pouch Carton
    acetaminophen, aspirin, and caffeine tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:66715-5738(NDC:47682-228)
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D) Acetaminophen 250 mg
    Aspirin (UNII: R16CO5Y76E) (Aspirin - UNII:R16CO5Y76E) Aspirin 250 mg
    Caffeine (UNII: 3G6A5W338E) (Caffeine - UNII:3G6A5W338E) Caffeine 65 mg
    Inactive Ingredients
    Ingredient Name Strength
    Hypromelloses (UNII: 3NXW29V3WO)  
    Maltodextrin (UNII: 7CVR7L4A2D)  
    Cellulose, Microcrystalline (UNII: OP1R32D61U)  
    Polyethylene Glycols (UNII: 3WJQ0SDW1A)  
    Povidones (UNII: FZ989GH94E)  
    Sodium Starch Glycolate Type A Corn (UNII: AG9B65PV6B)  
    Starch, Corn (UNII: O8232NY3SJ)  
    Stearic Acid (UNII: 4ELV7Z65AP)  
    Titanium Dioxide (UNII: 15FIX9V2JP)  
    Product Characteristics
    Color WHITE Score no score
    Shape ROUND Size 11mm
    Flavor Imprint Code FR9
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:66715-5738-1 1 in 1 CARTON
    1 2 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part343 11/01/2014
    Labeler - Lil' Drug Store Products, Inc (093103646)