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

  • 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 December 20, 2018

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

  • Purposes

    Pain reliever

    Pain reliever

    Pain reliever aid

  • Uses

    • temporarily relieves minor aches and pains due to:
      • headache
      • a cold ​
      • arthritis
      • muscular aches  ​​​
      • toothache
      • premenstrual and 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: 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 a 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 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: 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 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

    • an allergic reaction occurs. Seek medical help right away.
      • any new symptoms appear
    • 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
    • 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 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.

  • 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
  • Other information

    • store between 20º-25ºC (68º-77ºF)
  • Inactive ingredients

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

    **contains one or more of these ingredients

  • Questions or comments?

    Call toll free 1-800-289-8343 Monday-Friday 9AM-4PM CST

  • Principal Display Panel

    †COMPARE TO  the active ingredients of Excedrin® Extra Strength

    Headache Relief

    Acetaminophen 250 mg - Pain Reliever

    Aspirin (NSAID) 250 mg - Pain Reliever

    Caffeine 65 mg - Pain Reliever Aid

    Extra Strength

    EASY OPEN CAP

    NOT FOR HOUSEHOLDS WITH YOUNG CHILDREN

    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.

    DISTRIBUTED BY HY-VEE, INC.

    WEST DES MOINES, IA 50266

    CALL 1-800-289-8343

    www.hyvee.com

  • Package Label

    Acetaminophen 250 mg Aspirin 250 mg (NSAID)* Caffeine 65 mg *nonsteroidal anti-inflammatory drug

    HY-VEE Headache Relief Extra Strength

  • INGREDIENTS AND APPEARANCE
    HEADACHE RELIEF  EXTRA STRENGTH
    acetaminophen, aspirin, caffeine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42507-525
    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
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeCAPSULESize17mm
    FlavorImprint Code TCL370;S53
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42507-525-25250 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/31/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34307/31/2016
    Labeler - Hy-Vee (006925671)