Label: SEDAL3X- acetaminophen, aspirin, caffeine tablet

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated June 4, 2024

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

  • Drug facts

  • ACTIVE INGREDIENT

  • PURPOSE

    Active ingredients
    (in each caplets)

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

  • Uses

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

  • Warnings

    Allergy alert

    Aspirin may cause a severe allergic reaction, which may include:
    hives
    shock
    facial swelling
    asthma (wheezing)

    Liver warning

    This product contains acetaminophen. Severe liver damage may occur if you take:
    more than 8 tablets in 24 hours, wich 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 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 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 if:
    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 for 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.

    Overdose warning

    In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) 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 tablets every 6 hours
    do not take more than 8 tablets 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)
    TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAPS IS BROKEN OR MISSING

  • Inactive ingredients

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

  • SPL UNCLASSIFIED SECTION

    Manufactured in:
    GMP Registered Facility in the USA


    Made for:

    inov FARMACEUTIQUE

    Exclusively distributed by:
    OPMX
    Chula Vista, CA 91910
    PHONE: 619-600-5632

  • SPL UNCLASSIFIED SECTION

    Sedal3x

    Acetaminophen 250 mg

    Aspirin 250 mg
    Caffeine 65 mg

    Pain Reliever

    40 Caplets

  • PRINCIPAL DISPLAY PANEL - 40 CAPLETS

    NDC 69729-055-40

    Sedal3x

    Acetaminophen 250 mg Pain reliever

    Aspirin 250 mg Pain reliever
    Caffeine 65 mg Pain reliever

    40 Caplets

    Sedal3X 40_caps

  • INGREDIENTS AND APPEARANCE
    SEDAL3X 
    acetaminophen, aspirin, caffeine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69729-055
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN250 mg
    CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE65 mg
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN250 mg
    Inactive Ingredients
    Ingredient NameStrength
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)  
    CROSPOVIDONE (UNII: 2S7830E561)  
    POVIDONE (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeCAPSULESize17mm
    FlavorImprint Code S53
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69729-055-401 in 1 CARTON09/07/2022
    140 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01309/07/2022
    Labeler - OPMX LLC (029918743)
    Establishment
    NameAddressID/FEIBusiness Operations
    ELYSIUM PHARMACEUTICALS LIMITED915664486analysis(69729-055) , label(69729-055) , manufacture(69729-055) , pack(69729-055)