Label: SEDALMEX FORTE- acetaminophen, aspirin, caffeine tablet

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

Drug Label Information

Updated February 28, 2024

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

  • Drug Facts

  • Active ingredients (in each tablet)

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

  • Purpose

    Pain reliever/fever reducer
    Pain reliever/fever reducer
    Pain reliever aid

  • Uses

    temporarily relieves minor aches and pains due to:

    • headache  • muscular aches    • arthritis pain

    • a cold       • toothache            • premenstrual and 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 (NSAIDs) 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)
    • take more or for a longer time than directed 
    • have 3 or more alcoholic drinks every day while using this product 

    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 

    • 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 ever have had an allergic reaction to acetaminophen, aspirin or any other pain relievers/fever reducers

    Ask a doctor before use if
    • stomach bleeding warning applies to you
    • you have high blood pressure, heart disease, liver cirrhosis, or kidney disease 
    • you are taking a diuretic • you have a history of stomach problems, such as heartburn
    • you have asthma • you have liver disease

    Ask a doctor or pharmacist before use if you are

    • if you are taking prescription drug for gout, diabetes, or arthritis
    • taking any other drug, or 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

    • pain gets worse or lasts more than 10 days
    • fever gets worse or lasts more than 3 days
    • ringing in the ears or loss of hearing occurs
    • painful area is red or swollen 
    • any new symptoms occur

    These could be signs of a serious condition.

    If pregnant or breast-feeding, ask a health care professional before use. It is especially important not to use aspirin at 20 weeks or later in 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.

  • Directions

    • do not use more than directed
    • drink a full glass of water with each dose


    Adults and children:

    (12 years and older)

     Take 2 Tablets every 6 hours as needed; not more than 8 tablets in 24 hours
     Children under 12 years:  Ask a doctor

  • Other information

    • read all product information before using. Keep box for important information.

    • store at room temperature between 68°-77°F (20°-25°C)

    • avoid excessive heat and humidity 

    • tamper evident sealed packets

    • do not use any opened or torn packets

    each tablet contains: Magnesium 0.58 mg 

  • Inactive ingredients

    colloidal silicon dioxide, hypromellose, microcrystalline cellulose, polyvinyl pyrrolidone, polyethylene glycol, pregelatinized starch, starch 1500, stearic acid, talc

  • Questions or comments?

    1-888-779-2877 M-F 9AM-5PM EST

  • SPL UNCLASSIFIED SECTION

    Fast Headache Relief!

    KEEP OUTER PACKAGE FOR COMPLETE PRODUCT INFORMATION

    Distributed by 

    Belmora LLC, 3033 Wilson BLvd.,

    Suite 700. Arlington, VA 22201,                                                              

    MADE IN INDIA

  • Packaging

    image description

  • INGREDIENTS AND APPEARANCE
    SEDALMEX FORTE 
    acetaminophen, aspirin, caffeine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:27854-303
    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
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POVIDONE K30 (UNII: U725QWY32X)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    Product Characteristics
    Colorwhite (WHITE TO OFF WHITE WITH SPECKS) Scoreno score
    Shapecapsule (CAPSULE SHAPED BICONVEX) Size18mm
    FlavorImprint Code S53
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:27854-303-0140 in 1 BOX06/01/2024
    11 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01306/01/2024
    Labeler - Belmora LLC (112753244)