Label: DOLODOL- acetaminophen, aspirin, caffeine tablet

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

Drug Label Information

Updated January 26, 2024

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

  • Drug facts

  • ACTIVE INGREDIENT

    Active ingredients
    (in each caplets)

    Acetaminophen 250 mg
    Aspirin 250 mg (NSAID)*
    Caffeine 65 mg


    *nonsteroidal anti-inflammatory drug

  • PURPOSE

    Acetaminophen 250 mg..........Pain reliever

    Aspirin 250 mg (NSAID)*........Pain reliever
    Caffeine 65 mg........................Pain reliever aid


    *nonsteroidal anti-inflammatory drug

  • Uses

    temporarily relieves minor aches and pains due to:

    • headache
    • a cold
    • arthritis
    • muscular aches
    • sinusitis
    • 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

    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
    • 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.

    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

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

    Made for:
    inov FARMACEUTIQUE

  • SPL UNCLASSIFIED SECTION

    DOLODOL
    Caplets
    Cabeza - Muela - Dental 24 caplets

  • PRINCIPAL DISPLAY PANEL - 24 Caplets

    DOLODOL 24 CAPLETSNDC 69729-601-24

    DOLODOL


    Alivio temporal de molestias y dolores menores de:

    Fiebre, Cabeza y Dental

    Fever and temporarily relieves minor aches and pain due to:

    Headache-Toothache-Minor pain

    24 Caplets

  • INGREDIENTS AND APPEARANCE
    DOLODOL 
    acetaminophen, aspirin, caffeine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69729-601
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE65 mg
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN250 mg
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN250 mg
    Inactive Ingredients
    Ingredient NameStrength
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POVIDONE (UNII: FZ989GH94E)  
    SODIUM STARCH GLYCOLATE TYPE B (UNII: SP4S77AHO6)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    CROSPOVIDONE (UNII: 2S7830E561)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeCAPSULE (Capsule shape) Size17mm
    FlavorImprint Code S53
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69729-601-242 in 1 CARTON09/06/2022
    112 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01309/06/2022
    Labeler - OPMX LLC (029918743)