Label: EXTRA STRENGTH PAIN RELIEVER- acetaminophen, aspirin and caffeine tablet, film coated

  • NDC Code(s): 57896-216-01
  • Packager: Geri-Care Pharmaceutical Corp
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 19, 2023

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

  • Active ingredients (in each caplet)

    ACETAMINOPHEN 250 MG

    ASPIRIN 250 MG (nsaid-nonsteroidal anti-inflammatory drug)

    CAFFEINE 65 MG

  • Purposes

    PAIN RELIEVER - PAIN RELIEVER AID

  • USES

    • temporarily relieves minor aches and pains
  • 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: Aspirin may cause a severe allergic reaction which may include:
    • hives • facial swelling • asthma (wheezing) • shock
    Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: • rash
    • skin reddening • blisters If a skin reaction occurs, stop use and seek medical help right away.
    Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
    • more than 4,000 mg of acetaminophen in 24 hours • 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 • 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) • are age 60 or older
    • 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

    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.
    • if you have ever had an allergic reaction to this product or any of its ingredients

    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 are taking a diuretic
    • you have asthma

    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

    • 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 pain that does not get better
    • ringing in the ears or loss of hearing occurs
    • painful area is red or swollen
    • pain gets worse or lasts for more than 10 days
    • fever gets worse or lasts for more than 3 days
    • new symptoms occur 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

    Keep out of reach of children. In case of accidental overdose, get medical help or contact
    a Poison Control Center (1-800-222-1222) right away. Prompt 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; not more than 8 caplets in 24 hours
    • children under 12: ask a doctor
  • Other information

    • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • INACTIVE INGREDIENTS

    corn starch, crospovidone, hypromellose,
    microcrystalline cellulose, povidone, propylene glycol, sodium lauryl sulfate,
    sodium starch glycolate, stearic acid, titanium dioxide

  • Questions or comments?

    1-800-540-3765

  • Package label

    1

  • INGREDIENTS AND APPEARANCE
    EXTRA STRENGTH PAIN RELIEVER 
    acetaminophen, aspirin and caffeine tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57896-216
    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
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    CROSPOVIDONE (UNII: 2S7830E561)  
    POVIDONE (UNII: FZ989GH94E)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeCAPSULE (CAPSULE SHAPED TABLET) Size17mm
    FlavorImprint Code 44;334
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57896-216-01100 in 1 BOTTLE; Type 0: Not a Combination Product02/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01302/01/2020
    Labeler - Geri-Care Pharmaceutical Corp (611196254)
    Registrant - Geri-Care Pharmaceutical Corp (611196254)