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 July 3, 2025

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

  • DO NOT USE IF PRINTED SEAL UNDER CAP IS MISSING OR DAMAGED READ ALL PRODUCT INFORMATION BEFORE USING. KEEP BOX FOR IMPORTANT INFORMATION. Drug Facts

    Active ingredients (in each tablet)                                                          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 tablets 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 
    • fever gets worse or lasts for more than 3 days 
    • new or unexpected symptoms occur 
    • ringing in the ears or loss of hearing occurs.
  • 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 use more than directed
    • adults: take 2 tablets with a glass of water
    • if symptoms persist or worsen, ask your doctor 
    • do not take more than 8 tablets in 24 hours, unless directed by a doctor
    • under 18 years of age: ask a doctor

    Other information

    • store at controlled room temperature 20°-25°C (68°-77°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 , sodium starch glycolate , stearic acid, talc

  • QUESTIONS

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

    Distributed by:
    Rising Pharma Holdings, Inc.

    East Brunswick, NJ 08816

    Made in India

    Mfg. Lic. No.: G/25/1362

    Issued: 06/2025
    S-066


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

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Acetaminophen, Aspirin (NSAID*) and Caffeine Tablets USP, 250mg/250mg/65mg

    NDC 57237-348-01

    100 Tablets

    acetam-asp-caff-label

  • 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)