Label: ACETAMINOPHEN, ASPIRIN AND CAFFEINE tablet

  • NDC Code(s): 57237-348-01
  • Packager: Rising Pharma Holdings, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 6, 2025

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

  • DO NOT USE IF PRINTED SEAL UNDER CAP IS MISSING OR DAMAGED Drug Facts

    Active ingredients (in each caplet)                                                          Purposes
    Acetaminophen USP, 250 mg...............................................................Pain reliever
    Aspirin USP, 250 mg (NSAID*).............................................................Pain reliever
    Caffeine USP, 65 mg........................................................................Pain reliever aid
    *nonsteroidal anti-inflammatory drug

  • PURPOSE

  • Uses

    • temporarily relieves minor aches and pains due to:
    • headache 
    • a cold
    • arthritis 
    • muscular aches
    • 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 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 
    • asthma (wheezing)
    • shock.

    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 heart beat.

  • 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 DOCTOR

    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 DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if you are

    • taking a prescription drug for:
    • diabetes 
    • gout 
    • arthritis 
    • taking any other drug, or are under a doctor's care for any serious condition 
    • taking any other product that contains aspirin, acetaminophen, or any other pain reliever/fever reducer.
  • STOP USE

    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
    • pain gets worse or lasts for more than 10 days
    • fever gets worse or lasts for more than 3 days
    • redness or swelling is present
    • any new symptoms occur. These could be signs of a serious condition
  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin during 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 (1-800-222-1222). 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 take 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: ask a doctor

    Other information

    • store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F)
    • close cap tightly after use
    • read all product information before using.
  • Inactive ingredients

    Colloidal silicon dioxide , hypromellose, microcrystalline cellulose , polyethylene glycol, povidone, pregelatinized starch, stearic acid, talc

  • QUESTIONS

    Questions and comments? Call 1-844-474-7464

    Distributed by:
    Rising Pharma Holdings, Inc.
    East Brunswick, NJ 08816Made in IndiaMfg. Lic. No.: G/25/1362

    Issued: 09/2025
    S-066


    +This product is not manufactured or distributed by the owner of the registered trademark Excedrin® Extra Strength

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    EXTRA STRENGTH Acetaminophen, Aspirin (NSAID) and Caffeine
    250mg/250mg/65mg

    NDC 57237-348-01

    100 Caplets

    aceta-asp-caff-caplets

  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN, ASPIRIN AND CAFFEINE 
    acetaminophen, aspirin and caffeine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57237-348
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN250 mg
    ASPIRIN (UNII: R16CO5Y76E) (ACETYLSALICYLIC ACID - UNII:R16CO5Y76E) ASPIRIN250 mg
    CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE65 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    Product Characteristics
    Colorwhite (Off White) Scoreno score
    ShapeROUNDSize11mm
    FlavorImprint Code S7
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57237-348-01100 in 1 BOTTLE; Type 0: Not a Combination Product07/09/2025
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01307/09/2025
    Labeler - Rising Pharma Holdings, Inc. (116880195)
    Registrant - Elysium Pharmaceuticals Ltd (915664486)
    Establishment
    NameAddressID/FEIBusiness Operations
    Elysium Pharmaceuticals Ltd863182240label(57237-348) , pack(57237-348)
    Establishment
    NameAddressID/FEIBusiness Operations
    Elysium Pharmaceuticals Ltd915664486manufacture(57237-348) , analysis(57237-348)