Label: EXTRA STRENGTH PAIN RELIEVER- acetaminophen, aspirin and caffeine capsule, gelatin coated

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 10/12

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

  • Active ingredients (in each gelcap)

    Acetaminophen 250 mg
    Aspirin 250 mg (NSAID)*
    Caffeine 65 mg

    *nonsteroidal anti-inflammatory drug

    Close
  • Purpose

    Pain reliever
    Pain reliever
    Pain reliever aid 

    Close
  • Uses

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

    Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use 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
    • shock
    • asthma (wheezing)

    Liver 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
    • have 3 or more alcoholic drinks every day while using this product
    • take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
    • 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, occassionally, rapid heartbeat.

    Do not use

    • if you ever had an allergic reaction to 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 a history of stomach problems, such as heartburn
    • you have high blood pressure, heart disease, liver cirrhosis or kidney disease
    • you have asthma
    • you are taking a diuretic 

    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 a 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 more than 3 days
    • painful area is red or swollen 

    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. 

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

    • store at controlled room temperature 15º-30ºC (59º-86ºF)
    • see end flap for expiration date and lot number 
    Close
  • Inactive ingredients

    corn starch, D&C yellow #10, FD&C blue #1, FD&C yellow #6, gelatin, hydroxypropyl cellulose, hypromellose, microcyrstalline cellulose, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, shellac glaze, simethicone, sodium lauryl sulfate, sodium starch glycolate, stearic acid, titanium dioxide 

    Close
  • Questions?

    1-800-901-5874

    Close
  • Principal display panel

    RITE AID®
    PHARMACY

    **Compare to the active ingredients in Excedrin®

    EXTRA STRENGTH
    pain reliever
    acetaminophen
    250 mg
    pain reliever • pain reliever aid

    80 QUICK RELEASE GELCAPS

    **This product is not manufactured or distributed by Novartis Consumer Health, Inc., owner of the registered trademark Excedrin®.

    50844    ORG011057131

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

    Rite Aid 44-571

    Rite Aid 44-571

    Close
  • INGREDIENTS AND APPEARANCE
    EXTRA STRENGTH PAIN RELIEVER 
    acetaminophen, aspirin, caffeine capsule, gelatin coated
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:11822-0751
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 250 mg
    ASPIRIN (ASPIRIN) ASPIRIN 250 mg
    CAFFEINE (CAFFEINE) CAFFEINE 65 mg
    Inactive Ingredients
    Ingredient Name Strength
    D&C YELLOW NO. 10  
    FD&C BLUE NO. 1  
    FD&C YELLOW NO. 6  
    HYPROMELLOSES  
    TITANIUM DIOXIDE  
    Product Characteristics
    Color GREEN Score no score
    Shape CAPSULE Size 21mm
    Flavor Imprint Code L;1
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:11822-0751-3 1 in 1 CARTON
    1 80 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part343 01/09/2009
    Labeler - Rite Aid (014578892)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 038154464 PACK(11822-0751)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 832867894 MANUFACTURE(11822-0751)
    Close