Dolodol

Description

No description information is available for the drug.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various conditions, including headache, cold, arthritis, muscular aches, sinusitis, toothache, and premenstrual and menstrual cramps.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Patients should adhere strictly to the recommended dosage. For adults and children aged 12 years and older, the prescribed dosage is 2 tablets every 6 hours, with a maximum limit of 8 tablets within a 24-hour period. It is essential to take each dose with a full glass of water to ensure proper administration and absorption.

For children under 12 years of age, it is advised to consult a healthcare professional for appropriate dosing recommendations.

Contraindications

Use is contraindicated in patients with a history of allergic reactions to acetaminophen, aspirin, or any other pain reliever or fever reducer. Additionally, this product should not be used concurrently with any other medication containing acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in another medication, consultation with a healthcare professional is advised.

Warnings and Precautions

Children and teenagers who are experiencing or recovering from chickenpox or flu-like symptoms should not use this product due to the risk of Reye's syndrome. If any changes in behavior accompanied by nausea and vomiting occur while using this product, it is imperative to consult a healthcare professional, as these symptoms may indicate the onset of this rare but serious condition.

Aspirin, a component of this product, may provoke severe allergic reactions. Symptoms of such reactions can include hives, shock, facial swelling, and asthma-related wheezing. Immediate medical attention should be sought if any of these symptoms occur.

This product contains acetaminophen, which poses a risk of severe liver damage if the following conditions are met: exceeding 8 tablets within a 24-hour period, concurrent use with other medications containing acetaminophen, or consumption of three or more alcoholic drinks daily while using this product.

The presence of a nonsteroidal anti-inflammatory drug (NSAID) in this formulation raises the potential for severe stomach bleeding. The risk is heightened in individuals aged 60 or older, those with a history of stomach ulcers or bleeding disorders, and patients taking anticoagulants or steroid medications. Additionally, the risk increases with the use of other NSAIDs (including aspirin, ibuprofen, or naproxen), excessive alcohol consumption, or prolonged use beyond the recommended duration.

Caffeine is also present in the recommended dosage of this product, which is comparable to the caffeine content of a standard cup of coffee. Patients are advised to limit the intake of other caffeine-containing medications, foods, or beverages, as excessive caffeine consumption may lead to symptoms such as nervousness, irritability, sleeplessness, and, in some cases, rapid heartbeat.

Healthcare professionals should advise patients to consult a doctor prior to use if they have liver disease, a history of stomach problems (including heartburn), high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or if they are taking diuretics.

In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center (1-800-222-1222) should be contacted. Prompt medical intervention is crucial for both adults and children, even in the absence of noticeable symptoms.

Patients should discontinue use and contact a healthcare provider if they experience any signs of stomach bleeding, such as feeling faint, having bloody or black stools, vomiting blood, or experiencing persistent stomach pain. Additionally, any occurrence of an allergic reaction warrants immediate medical attention. Patients should also seek medical help if new symptoms arise, if they experience ringing in the ears or hearing loss, if pain worsens or persists beyond 10 days, if fever intensifies or lasts more than 3 days, or if the affected area becomes red or swollen.

Side Effects

Patients using this product may experience a range of adverse reactions, some of which may be serious.

Serious Adverse Reactions Reye's syndrome is a rare but serious illness that can occur in children and teenagers who have or are recovering from chickenpox or flu-like symptoms. Patients should be advised to discontinue use and consult a doctor if they experience changes in behavior accompanied by nausea and vomiting, as these may be early signs of Reye's syndrome.

A severe allergic reaction to aspirin may manifest as hives, shock, facial swelling, or asthma (wheezing). Patients experiencing any signs of an allergic reaction should seek immediate medical attention.

This product contains acetaminophen, and severe liver damage may occur if patients exceed the maximum daily dosage of 8 tablets in 24 hours, use it in conjunction with other acetaminophen-containing products, or consume 3 or more alcoholic drinks daily while using this product.

Additionally, the presence of an NSAID in this product raises the risk of severe stomach bleeding, particularly in patients who are 60 years or older, have a history of stomach ulcers or bleeding problems, are taking anticoagulants or steroid drugs, or are consuming alcohol excessively. Patients should be instructed to stop use and consult a doctor if they experience symptoms indicative of stomach bleeding, such as feeling faint, having bloody or black stools, vomiting blood, or experiencing persistent stomach pain.

Common Adverse Reactions Patients may also experience less severe but notable reactions. The recommended dose of this product contains caffeine, which may lead to nervousness, irritability, sleeplessness, and occasionally rapid heartbeat if combined with other caffeine-containing medications, foods, or beverages.

Additional Considerations Patients should be advised to consult a doctor before using this product if they have liver disease, a history of stomach problems (such as heartburn), high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma. It is also recommended that patients inform their healthcare provider if they are taking prescription medications for diabetes, gout, or arthritis, or if they are under care for any serious condition.

Patients should seek medical help if any new symptoms appear, if they experience ringing in the ears or loss of hearing, if pain worsens or lasts longer than 10 days, or if fever persists or worsens beyond 3 days.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Dolodol (acetaminophen, aspirin, caffeine). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product due to the risk of Reye's syndrome, a rare but serious illness. If changes in behavior accompanied by nausea and vomiting occur while using this product, it is important to consult a doctor, as these symptoms may indicate the onset of Reye's syndrome.

For dosing, adults and children aged 12 years and older are directed to take 2 tablets every 6 hours, with a maximum of 8 tablets in a 24-hour period. For children under 12 years, it is advised to consult a doctor before use.

Geriatric Use

Elderly patients, particularly those aged 60 years and older, are at an increased risk of severe stomach bleeding when using this product, which contains a nonsteroidal anti-inflammatory drug (NSAID). It is essential for healthcare providers to exercise caution when prescribing this medication to geriatric patients, as the likelihood of adverse gastrointestinal events may be heightened in this population.

Before initiating treatment, healthcare providers should inquire about the presence of comorbid conditions in elderly patients, such as high blood pressure, heart disease, liver cirrhosis, or kidney disease, as these factors may necessitate closer monitoring or alternative therapeutic strategies.

Patients should be advised to discontinue use and seek medical attention immediately if they experience any signs indicative of stomach bleeding, including feeling faint, the presence of bloody or black stools, vomiting blood, or persistent stomach pain that does not improve. Regular assessment and vigilant monitoring of these symptoms are crucial in managing the safety of NSAID therapy in geriatric patients.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional before using this medication. The use of aspirin during the last trimester of pregnancy is particularly concerning, as it may lead to adverse effects on fetal outcomes or complications during delivery. Therefore, it is crucial that pregnant patients only use aspirin in the final three months of pregnancy if explicitly directed by a healthcare provider.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. It is particularly important to avoid the use of aspirin during the last three months of pregnancy unless explicitly directed by a physician, as it may pose risks to the unborn child or lead to complications during delivery. There is no specific data available regarding the excretion of this medication in breast milk or its effects on breastfed infants. Therefore, caution is recommended when considering the use of this medication while breastfeeding.

Renal Impairment

Patients with renal impairment should consult a healthcare professional prior to use, particularly if they have conditions such as high blood pressure, heart disease, liver cirrhosis, or kidney disease. It is essential to assess renal function and consider potential dosing adjustments or monitoring requirements based on the severity of renal impairment.

Hepatic Impairment

Patients with hepatic impairment should exercise caution when using this product, as it contains acetaminophen, which is associated with the risk of severe liver damage. The maximum recommended dosage is 8 tablets in a 24-hour period. Exceeding this dosage, using other medications that contain acetaminophen concurrently, or consuming 3 or more alcoholic drinks daily while using this product may significantly increase the risk of liver injury.

It is advised that patients with liver disease, high blood pressure, heart disease, liver cirrhosis, or kidney disease consult a healthcare professional prior to use. Monitoring of liver function may be warranted in these patients to ensure safety and efficacy while using this product.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222. Prompt medical intervention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Healthcare professionals should be aware that the severity of symptoms may vary based on the specific substance involved in the overdose. Therefore, a thorough assessment and monitoring of the patient are essential.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous evaluation and appropriate interventions should be implemented to mitigate potential complications arising from the overdose.

Nonclinical Toxicology

It is especially important not to use aspirin during the last three months of pregnancy unless definitely directed to do so by a doctor, as it may cause problems in the unborn child or complications during delivery. No relevant information is available regarding non-teratogenic effects, nonclinical toxicology, or animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions reported voluntarily or through surveillance programs. These include allergic reactions such as hives, shock, and facial swelling. Additionally, severe liver damage has been associated with excessive intake of acetaminophen. There have been reports of severe stomach bleeding linked to the use of nonsteroidal anti-inflammatory drugs (NSAIDs), particularly in individuals over 60 years of age or those with a history of stomach ulcers or bleeding problems. Furthermore, there is an increased risk of adverse effects when NSAIDs are combined with alcohol or other medications containing NSAIDs. Lastly, reports indicate that excessive caffeine intake may lead to symptoms such as nervousness, irritability, sleeplessness, and rapid heartbeat.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. Patients must be informed not to use the medication if they have ever experienced an allergic reaction to acetaminophen, aspirin, or any other pain reliever or fever reducer.

It is crucial to instruct patients not to use this medication in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription. If patients are uncertain whether a drug contains acetaminophen, they should be encouraged to consult a doctor or pharmacist for clarification.

Patients should be made aware of the signs of potential stomach bleeding and instructed to stop use and seek medical attention if they experience any of the following symptoms: feeling faint, having bloody or black stools, vomiting blood, or experiencing stomach pain that does not improve. Additionally, they should be advised to seek immediate medical help if any allergic reactions occur, if new symptoms appear, if they experience ringing in the ears or loss of hearing, if pain worsens or lasts longer than 10 days, if fever worsens or lasts longer than 3 days, or if the painful area becomes red or swollen.

Patients should be encouraged to consult a doctor before using this medication if they have liver disease, a history of stomach problems such as heartburn, high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma. Furthermore, patients taking a diuretic or any prescription drug for diabetes, gout, or arthritis should also seek medical advice prior to use. It is important for patients to discuss any other medications they are taking or any serious medical conditions they are managing with their healthcare provider or pharmacist before using this medication.

Storage and Handling

The product is supplied in a configuration that includes a tamper-evident seal. It is essential to inspect the safety seal under the cap; the product should not be used if the seal is broken or missing.

Storage conditions require the product to be maintained at a temperature of 25°C (77°F). However, excursions are permitted within a range of 15-30°C (59-86°F). Proper adherence to these storage guidelines is crucial to ensure the integrity and efficacy of the product.

Additional Clinical Information

The medication is administered orally, with the recommended dosage for adults and children aged 12 years and older being 2 tablets every 6 hours, not to exceed 8 tablets in a 24-hour period. For children under 12 years, it is advised to consult a doctor before administration.

Clinicians should counsel patients regarding the use of this medication during pregnancy or breastfeeding, emphasizing the importance of consulting a health professional prior to use. It is particularly critical to avoid aspirin in the last trimester of pregnancy unless specifically directed by a physician, as it may pose risks to the unborn child or lead to complications during delivery.

Drug Information (PDF)

This file contains official product information for Dolodol, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)