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

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

Drug Label Information

Updated December 14, 2023

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  • Drug Facts

  • Active ingredients

    Active ingredients (in each caplet)

    Acetaminophen 250 mg

    Aspirin (NSAID*) 250 mg

    Caffeine 65 mg

    *nonsteroidal anti-inflammatory drug

  • Purposes

    Purposes

    Pain reliever

    Pain reliever

    Pain reliever aid

  • Uses

    Uses

    temporarily relieves minor aches and pains due to:

    • headache
    • a cold
    • arthritis
    • muscular aches
    • toothache
    • premenstrual & 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: 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.

    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 olde
    • have had stomach ulcers or bleeding problems
    • 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. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • Directions

    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 capletsevery 6 hours as needed;

    not more than 8 caplets in 24 hours
    children under 12 yearsask a doctor

  • Other information

    Other information

    • store at 68°-77°F (20°-25°C); excursions permitted between 59°-86°F (15°-30°C)
    • avoid excessive heat and humidity
    • each caplet contains: Magnesium 0.58 mg
  • Inactive ingredients

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

  • Questions or comments?

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

  • SPL UNCLASSIFIED SECTION

    Product manufactured for:
    Lil' Drug Store Products, Inc., 9300 Earhart Lane SW, Cedar Rapids, IA 52404
    www.lildrugstore.com 54383C-US-08-21


    Proudly distributed by Circle K Stores Inc.


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

  • PDP/Package

    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

    6 caplets (2 per pouch)

    PDP/Package

  • INGREDIENTS AND APPEARANCE
    HEADACHE, CIRCLE K 
    acetaminophen, caffeine, aspirin tablet tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66715-5438(NDC:68210-0107)
    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
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE K30 (UNII: U725QWY32X)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    Product Characteristics
    Colorwhite (white to off-white, with specks) Scoreno score
    ShapeOVAL (capsule-shaped biconvex) Size18mm
    FlavorImprint Code S53
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66715-5438-33 in 1 CARTON09/17/2021
    16 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01309/17/2021
    Labeler - Lil' Drug Store Products, Inc. (093103646)
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