Dolodol

Description

DOLODOL (NDC 69729-601-24) is formulated for the temporary relief of minor aches and pains associated with fever, headache, toothache, and other minor discomforts. The product is presented in the form of 24 caplets, designed for convenient dosing.

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, concurrent use with any other medication containing acetaminophen, whether prescription or nonprescription, is contraindicated. If there is uncertainty regarding the presence of acetaminophen in a medication, consultation with a healthcare professional is advised.

Warnings and Precautions

Children and teenagers who have or are recovering from chickenpox or flu-like symptoms should not use this product. If behavioral changes accompanied by nausea and vomiting occur during use, it is imperative to consult a physician, as these symptoms may indicate the onset of Reye's syndrome, a rare but serious condition.

Aspirin, a component of this product, has the potential to cause severe allergic reactions, which may manifest as hives, shock, facial swelling, or asthma symptoms such as wheezing.

This product contains acetaminophen, and severe liver damage may occur if the following conditions are met: exceeding 8 tablets within a 24-hour period (the maximum daily dosage), concurrent use with other medications containing acetaminophen, or consumption of three or more alcoholic beverages daily while using this product.

Additionally, this product contains a nonsteroidal anti-inflammatory drug (NSAID), which may lead to severe stomach bleeding. The risk of such an event is heightened in individuals who are 60 years of age or older, have a history of stomach ulcers or bleeding disorders, are taking anticoagulants or steroid medications, are using other NSAIDs (including aspirin, ibuprofen, or naproxen), consume three or more alcoholic drinks daily, or exceed the recommended dosage or duration of use.

The recommended dosage of this product contains approximately the same amount of caffeine as a standard cup of coffee. Therefore, it is advisable to limit the intake of other caffeine-containing medications, foods, or beverages while using this product, 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 physician prior to use if they have liver disease, if the stomach bleeding warning is applicable, if they have a history of gastrointestinal issues such as heartburn, or if they have conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma. Additionally, patients should seek medical advice if they are taking diuretics, prescription medications for diabetes, gout, or arthritis, or if they are under a physician's care for any serious medical condition.

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 attention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Patients should discontinue use and contact a physician if they experience any signs of stomach bleeding, including feeling faint, having bloody or black stools, vomiting blood, or experiencing persistent stomach pain. Immediate medical help should also be sought for any allergic reactions, the emergence of new symptoms, ringing in the ears or hearing loss, worsening pain lasting more than 10 days, fever persisting for more than 3 days, or if a painful area becomes red or swollen.

Side Effects

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

Serious Adverse Reactions Reye's syndrome is a rare but serious illness that may 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.

Aspirin, a component of this product, may cause severe allergic reactions, which can manifest as hives, shock, facial swelling, or asthma (wheezing). Patients with a known allergy to acetaminophen, aspirin, or any other pain reliever/fever reducer should not use this product.

Severe liver damage is a potential risk associated with the use of this product, particularly if patients exceed the maximum daily dosage of 8 tablets within 24 hours, use it in conjunction with other drugs containing acetaminophen, or consume three or more alcoholic drinks daily while using this product.

The product contains a nonsteroidal anti-inflammatory drug (NSAID), which may lead to severe stomach bleeding. The risk of this adverse reaction is heightened in patients aged 60 or older, those with a history of stomach ulcers or bleeding problems, individuals taking blood thinners or steroid medications, and those consuming three or more alcoholic drinks daily while using this product. Patients should be cautioned against taking this product for longer than directed or in higher doses than recommended.

Common Adverse Reactions Patients may also experience less severe but notable side effects. The recommended dose of this product contains approximately the same amount of caffeine as a cup of coffee. Excessive caffeine intake may lead to nervousness, irritability, sleeplessness, and, in some cases, rapid heartbeat. Therefore, patients are advised to limit the use of other caffeine-containing medications, foods, or beverages while taking this product.

Monitoring and Consultation Patients should be instructed to stop use and seek medical attention 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 allergic reactions, new symptoms, ringing in the ears, loss of hearing, worsening pain lasting more than 10 days, or fever lasting more than three days should prompt immediate medical consultation.

Before using this product, patients should consult a doctor 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 advisable for patients taking diuretics or prescription medications for diabetes, gout, or arthritis to seek medical advice prior to use.

Drug Interactions

Patients taking anticoagulants or steroid medications may experience increased risks of adverse effects when combined with other drugs. It is advisable to monitor for signs of bleeding or other complications and adjust dosages as necessary.

The concomitant use of nonsteroidal anti-inflammatory drugs (NSAIDs), including prescription and nonprescription options such as aspirin, ibuprofen, and naproxen, may enhance the risk of gastrointestinal irritation or bleeding. Caution is recommended, and monitoring for gastrointestinal symptoms is advised.

Additionally, patients on prescription medications for diabetes, gout, or arthritis should be closely monitored for potential interactions that could affect the efficacy of these treatments. Dosage adjustments may be required based on clinical response and tolerability.

No specific laboratory test interactions have been identified in the available data.

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

Pediatric patients, particularly children and teenagers, should not use this product if they have or are recovering from chicken pox or flu-like symptoms due to the risk of Reye's syndrome. It is important to consult a healthcare professional if any changes in behavior accompanied by nausea and vomiting occur, as these may be early signs of Reye's syndrome.

For children under 12 years of age, it is advised to seek medical guidance before use. The recommended dosing for patients aged 12 years and older is 2 tablets every 6 hours, with a maximum of 8 tablets in a 24-hour period.

Geriatric Use

Elderly patients, particularly those aged 60 and older, may have an increased risk of severe stomach bleeding. Healthcare providers should exercise caution when prescribing medications that may exacerbate this risk in this population. It is advisable to closely monitor these patients for any signs of gastrointestinal bleeding and to consider appropriate dose adjustments or alternative therapies as necessary to ensure their safety.

Pregnancy

Pregnant patients and women 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 this period if explicitly directed by a healthcare provider.

Lactation

Lactating mothers are advised to consult a health professional before using this medication. It is particularly important to avoid the use of aspirin during the last three months of pregnancy unless specifically 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 in lactating mothers.

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 consult a healthcare professional prior to using this product. The presence of liver disease may increase the risk of adverse effects, particularly due to the acetaminophen content in this formulation.

Severe liver damage may occur if patients exceed the maximum recommended dosage of 8 tablets within a 24-hour period. Additionally, caution is advised against the concurrent use of other medications containing acetaminophen, as this may further elevate the risk of hepatotoxicity.

Patients are also advised to limit alcohol consumption to fewer than 3 alcoholic drinks per day while using this product, as alcohol can exacerbate the potential for liver damage. Regular monitoring of liver function may be warranted in patients with compromised liver function to ensure safety and efficacy during treatment.

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 lack of immediate symptoms does not preclude the potential for serious health consequences. Therefore, vigilance and timely action are essential in managing overdose situations effectively.

Nonclinical Toxicology

It is especially important not to use aspirin during the last three months of pregnancy unless specifically directed by a healthcare professional, as it may lead to complications for the unborn child or during delivery. No additional non-teratogenic effects or specific nonclinical toxicology details have been identified in the available data. Furthermore, there are no reported findings related to 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, facial swelling, and asthma (wheezing). Additionally, severe liver damage has been associated with the use of acetaminophen.

Severe stomach bleeding has been 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. Symptoms indicative of stomach bleeding include feeling faint, having bloody or black stools, vomiting blood, and experiencing persistent stomach pain.

Newly reported symptoms encompass ringing in the ears or loss of hearing, worsening pain, and swelling in the affected area. There have also been reports of overdose, highlighting the importance of seeking medical assistance or contacting a Poison Control Center immediately in such cases.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. Patients should be informed not to use the medication if they have a history of allergic reactions to acetaminophen, aspirin, or any other pain reliever or fever reducer. It is crucial to instruct patients not to combine this medication with any other drug containing acetaminophen, whether prescription or nonprescription. If patients are uncertain about the contents of another medication, they should be encouraged to consult a doctor or pharmacist.

Patients should be made aware of the signs of potential stomach bleeding and instructed to stop use and seek medical attention if they experience symptoms such as feeling faint, having bloody or black stools, vomiting blood, experiencing persistent stomach pain, or if any allergic reaction occurs. Additionally, they should be advised to seek immediate medical help if any new symptoms arise.

Healthcare providers should counsel patients to discontinue use and consult a doctor if they experience ringing in the ears or loss of hearing. Patients should also be informed to stop use and seek medical advice if their pain worsens or lasts longer than 10 days, if their fever intensifies or persists for more than 3 days, or if the painful area becomes red or swollen.

It is important for healthcare providers to recommend that patients consult a doctor before using the medication if they have liver disease or if the warning regarding stomach bleeding applies to them. Patients with a history of stomach problems, such as heartburn, high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma should also be advised to seek medical guidance prior to use. Furthermore, patients taking diuretics or prescription medications for diabetes, gout, or arthritis should be encouraged to discuss their current medications with a doctor or pharmacist before using this product.

Storage and Handling

The product is supplied in a configuration that ensures tamper evidence; it should not be used if the imprinted safety seal under the cap is broken or missing.

Storage conditions require the product to be maintained at a temperature of 25°C (77°F), with permissible excursions between 15-30°C (59-86°F). It is essential to adhere to these temperature guidelines 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 use.

Clinicians should counsel patients to seek advice from a health professional if they are pregnant or breastfeeding. It is particularly crucial to avoid aspirin during 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)