Label: DOLEX FORTE- acetaminophen, aspirin, caffeine tablet

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated February 18, 2019

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active Ingredients and Purpose

    Active Ingridients.............................................. Purposes
    Acetaminophen 250 mg................................. Pain reliever
    Aspirin 250 mg (NSAID*)................................ Pain reliever
    Caffeine 65 mg................................................. Pain reliever aid

    * nonsteroidal anti-inflammatory drug

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  • Uses

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

    Aspirin may cause a severe allergic reaction which may include:

    • hives
    • facial swelling
    • shock
    • asthma (wheezing)

    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 have ever had an allergic reactionto 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 are taking a diuretic
    • you have asthma

    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

    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 for more than 10 days
    • redness or swelling is present
    • new symptoms occur
    • ringing in the ears or loss of hearing occurs

      These could be signs of a serious condition.

    If pregnant or breast-feeding,

    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. In case of overdose,
    get medical help or contact a Poison Control Center
    right away (1-800-222-1222). Quick medical
    attention is critical for adults as well as for children
    even if you do not notice any signs or symptoms.

    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).

    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

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  • Directions

    • do not use more than directed
    • drink a full glass of water with each dose
    • adults and children 12 years and over: take 4 to 8 tablets every 4 hours; do not exceed 48 tablets in 24 hours
    • children under 12 years: consult a doctor
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  • Other information

    • store between 20°-25°C (68°-77°F) in a dry place
    • retain carton for complete product information
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  • Inactive ingredients

    carnauba wax, colloidal
    silicon dioxide, hypromellose, microcrystalline
    cellulose, mineral oil, povidone, pregelatinized starch,
    sodium starch glycolate, stearic acid, titanium dioxide

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  • Questions?

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

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  • Principal Display Panel

    DOLEX®

    FORTE

    EXTRA STRENGTH


    Acetaminophen, Aspirin , Caffeine

    Pain reliever/Pain reliever Aid

    Alivio del dolor/Analgesico

    24 Caplets

    Dolex Forte

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  • INGREDIENTS AND APPEARANCE
    DOLEX FORTE 
    acetaminophen, aspirin, caffeine tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:55758-019
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 250 mg
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 250 mg
    CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE 65 mg
    Inactive Ingredients
    Ingredient Name Strength
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    POVIDONE (UNII: FZ989GH94E)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    Color white Score score with uneven pieces
    Shape CAPSULE ((Capsule-Shaped Tablet)) Size 19mm
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:55758-019-24 1 in 1 CARTON 03/25/2013
    1 24 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part356 01/25/2013
    Labeler - Pharmadel LLC (030129680)
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