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

  • NDC Code(s): 59726-247-24, 59726-247-50
  • Packager: P & L Development, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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 January 28, 2016

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

  • Active ingredients (in each caplet)

    Acetaminophen 250 mg

    Aspirin 250 mg (NSAID)*

    Caffeine 65 mg

    *nonsteroidal anti-inflammatory drug

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  • Purposes

    Pain reliever

    Pain reliever

    Pain reliever aid

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  • Uses

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

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

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

    Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:

    • more than 8 caplets in 24 hoursm 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 thining (anticoagulant) or steroid drug
    • take other drugs containing prescription or nonprescription NSAID (aspirin, ibuprofen, naproxen, or others)
    • have 3 or more alcoholic drinks every day while using this product
    • take more or for 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 whilr 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 asthma
    • you are taking a diuretic
    • you have a history of stomach problems, such as heartburn
    • you have high blood pressure, heart disease, liver cirrhosis, or kidney disease

    Ask a doctor or pharmacist before use if you are

    • taking a prescription drug for diabetes, gout, or arthritis
    • taking any other drug or are under a doctor’s care for any serious condition

    Stop use and ask doctor if

    • you experience any of the following signs of stomach bleeding:
      • feel faint
      • have bloody or black stools
      • vomit blood
      • have stomach pain that does not get better
    • an allergic reaction occurs. Seek medical help right away.
    • any new symptoms appear
    • ringing in the ears or loss of hearing occurs
    • pain gets worse or lasts for more than 10 days
    • fever gets worse or lasts for more than 3 days
    • painful area is red or swollen

    These could be a 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 right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

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  • 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 caplets every 6 hours; do not take more than 8 caplets in 24 hours
    • children under 12 years: do not use unless directed by a doctor
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  • Other information

    • store at controlled room temperature 20º-25ºC (68º-77ºF)
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  • Inactive ingredients

    carnauba wax**, colloidal silicon dioxide, corn starch, hypromellose, maltodextrin**, microcrystalline cellulose, mineral oil**, polydextrose**, povidone, sodium starch glycolate**, stearic acid, talc**, titanium dioxide, triglycerides**

    **contains one or more of these ingredients

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  • Questions or comments?

    Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

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  • Principal Display Panel

    Compare to the active ingredients in Excedrin® Extra Strength

    Extra Strength

    Headache Relief

    Acetaminophen

    Aspirin (NSAID) and Caffeine

    Pain Reliever / Pain Reliever Aid

    Caplets

    †This product is not manufactured or distributed by Novartis, distributor of Excedrin® Extra Strength.

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

    KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

    Distributed by:

    PL Developments

    200 Hicks Street

    Westbury, NY 11590

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  • Package Label

    Acetaminophen 250 mg, Aspirin 250 mg, Caffeine 65 mg

    Readyincase Extra Strength Headache Relief

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  • INGREDIENTS AND APPEARANCE
    HEADACHE RELIEF  EXTRA STRENGTH
    acetaminophen, aspirin, caffeine tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:59726-247
    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
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    POLYDEXTROSE (UNII: VH2XOU12IE)  
    POVIDONES (UNII: FZ989GH94E)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    C10-18 TRIGLYCERIDES (UNII: 43AGM4PHPI)  
    Product Characteristics
    Color WHITE Score no score
    Shape CAPSULE Size 17mm
    Flavor Imprint Code 2793;TCL370
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:59726-247-24 1 in 1 BOX
    1 24 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2 NDC:59726-247-50 1 in 1 BOX
    2 50 in 1 BOTTLE, PLASTIC; 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 05/01/2014
    Labeler - P & L Development, LLC (800014821)
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