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

  • NDC Code(s): 68210-4183-3
  • Packager: Spirit Pharmaceuticals LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 13, 2024

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  • Drug Facts
  • Active Ingredient (in each tablet)
    Acetaminophen - Aspirin - Caffeine
  • Purpose
    Pain reliever - Pain reliever - 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 ...
  • 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 ...
  • 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 ...
  • Ask a doctor or pharmacist before use if you are taking
    • any other drug containing an NSAID (prescription or non-prescription) • a prescription drug for diabetes, gout or arthritis • any other drug, or are under a doctor’s care for any ...
  • 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 ...
  • 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 ...
  • Keep out of reach of children.
  • 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 ...
  • 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 tablets every 6 hours; not more than 8 tablets ...
  • Other Information
    • store at controlled room temperature 20°-25° C (68°-77° F) • read all product information before using
  • Inactive ingredients
    Colloidal silicon dioxide, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid, talc
  • Questions or comments?
    1-888-333-9792
  • Distributed by:
    Cabinet Health P.B.C.
  • Pouch
    ES Headache Pouch
  • INGREDIENTS AND APPEARANCE
    Product Information