Label: DOLEX FORTE- acetaminophen, aspirin, caffeine tablet

  • NDC Code(s): 55758-306-02, 55758-306-24, 55758-306-50, 55758-306-99
  • Packager: Pharmadel LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 12, 2024

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  • Drug Facts

    Drug Facts

  • Active ingredients and Purposes

    Active ingredientsPurposes
    Acetaminophen 250 mg...................Pain reliever
    Aspirin (NSAID*) 250 mg ................ Pain reliever
    Caffeine 65 mg.................................Pain reliever aid/ diuretic

    * nonsteroidal anti-inflammatory drug

  • Uses

    Temporarily relieves minor aches and pains due to:

    • headache
    • a cold
    • arthritis
    • muscular aches
    • toothache
    • premenstrual and menstrual cramps and bloating
  • 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 (NSAID) 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

    • adult takes more than 4 doses in 24 hours, which is the maximum daily amount
    • child takes more than 3 doses in 24 hours
    • taken with other drugs containing acetaminophen
    • adult has 3 or more alcoholic drinks everyday while using this product

    Stomach bleeding warning: This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may cause severe stomach bleeding. The chance is higher if the user:

    • has had stomach ulcers or bleeding problems
    • takes a blood thinning (anticoagulant) or steroid drug
    • takes other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
    • takes more or for a longer time than directed
    • has 3 or more alcoholic drinks everyday 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 a rapid heartbeat.

    Do not use

    • if the user has 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 the user

    • has liver disease
    • has a history of stomach problems, such as heartburn
    • has high blood pressure, heart disease, liver cirrhosis, or kidney disease
    • takes a diuretic
    • has not been drinking fluids
    • has lost a lot of fluid due to vomiting or diarrhea
    • is a child with pain of arthritis
    • has asthma

    Ask a doctor before use if

    • a stomach bleeding warning applies to user

    Stop use and ask a doctor if

    • an allergic reaction occurs. Seek medical help right away.
    • users experience any of the following signs of stomach bleeding:
      • feel faint
      • vomit blood
      • has bloody or black stools
      • has stomach pain that does not get better
    • ringing in the ears or loss of hearing occurs
    • taking a prescription drug for diabetes, gout, or arthritis
    • adult's pain gets worse or lasts for more than 10 days
    • child's pain gets worse or lasts for more than 5 days
    • fever gets worse or lasts for more than 3 days
    • redness or swelling is present
    • new symptoms occur

    If pregnant or breastfeeding,

    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.

    In case of overdose, get medical help or contact a Poison Control Center 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

    • adults and children 12 years and over: two (2) caplets every 6 hours with a full glass of water with each dose. Do not exceed; adults 8 caplets and children 6 caplets in 24 hours .
    • children under 12 years of age: consult a doctor
  • Other information

    • store between 68°-77°F (20°-25°C)
    • read all product information before using.
    • Keep box for important information.
  • Inactive ingredients

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

  • Questions?

    1-866-359-3478 (M-F) 9AM to 5PM EST or www.pharmadel.com

  • Distributed by / Distribuido por:

    PHARMADEL LLC

    New Castle, DE, 19720

  • Principal Display Panel

    PDP DFORTE

  • INGREDIENTS AND APPEARANCE
    DOLEX FORTE 
    acetaminophen, aspirin, caffeine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55758-306
    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)  
    CROSPOVIDONE (UNII: 2S7830E561)  
    POVIDONE (UNII: FZ989GH94E)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)  
    Product Characteristics
    ColorwhiteScorescore with uneven pieces
    ShapeCAPSULE ((Capsule-Shaped Tablet)) Size18mm
    FlavorImprint Code S53
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55758-306-241 in 1 CARTON04/10/2023
    124 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:55758-306-5025 in 1 BOX04/25/202310/19/2023
    2NDC:55758-306-022 in 1 PACKET; Type 0: Not a Combination Product
    3NDC:55758-306-9950 in 1 CARTON10/19/2023
    3NDC:55758-306-022 in 1 PACKET; Type 0: Not a Combination Product
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01303/24/2013
    Labeler - Pharmadel LLC (030129680)
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