Dg Health Migraine Relief

Description

Acetaminophen, Aspirin (NSAID), and Caffeine Tablets are formulated as a pain reliever and pain reliever aid. Each package contains 24 coated caplets, which are capsule-shaped tablets designed for ease of swallowing. The combination of these active ingredients provides effective relief from various types of pain.

Uses and Indications

This drug is indicated for the treatment of migraine. There are no teratogenic or nonteratogenic effects mentioned in the available data.

Dosage and Administration

Adults are instructed to take 2 caplets with a full glass of water. It is essential not to exceed the recommended dosage of 2 caplets within a 24-hour period unless otherwise directed by a healthcare professional.

For individuals under 18 years of age, it is advised to consult a doctor prior to use. If symptoms persist or worsen, patients should seek medical advice.

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 other medications, 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.

Allergy Alerts This product contains acetaminophen, which may lead to severe skin reactions. Symptoms of such reactions can include skin reddening, blisters, and rash. In the event of a skin reaction, the user must discontinue use immediately and seek medical assistance.

Additionally, aspirin, another component of this product, may provoke a severe allergic reaction characterized by hives, facial swelling, asthma (wheezing), or shock. Immediate medical attention is warranted if any of these symptoms occur.

Liver Warning The presence of acetaminophen in this product necessitates caution, as severe liver damage can occur if the user exceeds the maximum daily dosage of 2 caplets within a 24-hour period, combines it with other medications containing acetaminophen, or consumes three or more alcoholic drinks daily while using this product.

Stomach Bleeding Warning This product contains a nonsteroidal anti-inflammatory drug (NSAID), which poses a risk of severe stomach bleeding. The likelihood of this adverse effect increases in individuals who are 60 years or older, have a history of stomach ulcers or bleeding problems, 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 duration or dosage of the product.

Medication Overuse Headache Warning Prolonged use of this product, specifically for 10 or more days per month, may exacerbate headache symptoms.

Caffeine Warning The recommended dosage of this product contains approximately the same amount of caffeine as a standard cup of coffee. Users should limit the intake of other caffeine-containing medications, foods, or beverages, as excessive caffeine consumption may lead to nervousness, irritability, sleeplessness, and, in some cases, rapid heartbeat.

Emergency Medical Help In the event of an overdose, it is crucial to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222. Prompt medical attention is essential for both adults and children, even if no signs or symptoms are initially apparent.

Discontinuation of Use Users should stop using this product and consult a healthcare professional if any of the following occur: an allergic reaction, signs of stomach bleeding (such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain), if migraine symptoms are not alleviated or worsen after the first dose, if new or unexpected symptoms arise, or if there is ringing in the ears or loss of hearing.

Side Effects

Patients using this product should be aware of several serious and common adverse reactions associated with its use.

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 not use this product in such cases, and if changes in behavior accompanied by nausea and vomiting occur, medical consultation is advised as these may be early signs of Reye’s syndrome.

Severe skin reactions have been reported in patients allergic to acetaminophen, with symptoms including skin reddening, blisters, and rash. If any skin reaction occurs, patients should discontinue use and seek immediate medical attention. Similarly, aspirin may provoke severe allergic reactions, which can manifest as hives, facial swelling, asthma (wheezing), or shock.

The product contains acetaminophen, which poses a risk of severe liver damage if patients exceed the maximum daily dosage of 2 caplets within 24 hours, use it in conjunction with other acetaminophen-containing medications, or consume three 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 aged 60 or older, those with a history of stomach ulcers or bleeding problems, or those taking anticoagulants, steroids, or other NSAIDs. The risk is further heightened with excessive alcohol consumption or prolonged use beyond the recommended duration. Patients should be vigilant for signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain.

Medication overuse headaches may occur if this product is used for 10 or more days per month, and patients should be cautious of caffeine intake, as excessive caffeine can lead to nervousness, irritability, sleeplessness, and occasionally rapid heartbeat.

Patients are advised to stop use and consult a doctor if they experience any allergic reactions, signs of stomach bleeding, worsening migraines after the first dose, new or unexpected symptoms, or symptoms such as ringing in the ears or loss of hearing.

Before using this product, patients should consult a healthcare professional if they have never had a migraine diagnosed, experience headaches that differ from their usual migraines, have the worst headache of their life, have fever and stiff neck, or have headaches following head injury, exertion, coughing, or bending. Additional caution is warranted for patients over 50 experiencing their first headache, those with daily headaches, severe migraines requiring bed rest, liver disease, or a history of stomach problems. Patients with high blood pressure, heart disease, liver cirrhosis, kidney disease, or those taking diuretics or with asthma should also seek medical advice prior to use.

This product should not be used by individuals with a known allergy to acetaminophen, aspirin, or any other pain reliever/fever reducer, or in conjunction with any other drug containing acetaminophen without consulting a healthcare professional.

Drug Interactions

The concomitant use of this product with caffeine-containing medications, foods, or beverages should be limited. Excessive caffeine intake may lead to adverse effects such as nervousness, irritability, sleeplessness, and, in some cases, rapid heartbeat.

Patients are advised to consult a healthcare professional prior to using this product if they are currently taking anticoagulants or steroid medications. Additionally, it is recommended that individuals seek medical advice if they are using other nonsteroidal anti-inflammatory drugs (NSAIDs), including but not limited to aspirin, ibuprofen, or naproxen.

Furthermore, individuals should inquire with their healthcare provider before using this product if they are taking any medications that contain acetaminophen, whether prescription or over-the-counter.

Patients on prescription medications for diabetes, gout, or arthritis should also consult their doctor before use. Lastly, those under medical supervision for any serious health condition are encouraged to discuss the use of this product with their healthcare provider.

Packaging & NDC

Below are the non-prescription pack sizes of Dg Health Migraine Relief (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. If any 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, a rare but serious condition.

For pediatric patients under 18 years of age, it is advised to consult a doctor before use.

Geriatric Use

Elderly patients, specifically those aged 60 years and older, should consult a healthcare provider prior to using this medication. This precaution is essential to ensure the safe and effective use of the treatment in this population, as age-related physiological changes may influence drug metabolism and response. Careful consideration and monitoring are advised when prescribing to geriatric patients to mitigate potential risks and optimize therapeutic outcomes.

Pregnancy

Pregnant patients and women who are breastfeeding should consult a healthcare professional before using this medication. The use of aspirin during pregnancy, particularly at 20 weeks gestation or later, is associated with potential risks. Specifically, aspirin may lead to adverse effects on fetal development and complications during delivery. Therefore, it is crucial that pregnant patients only use aspirin under the guidance of a qualified healthcare provider if deemed necessary.

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 at 20 weeks of gestation or later 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 during lactation.

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. It is critical that patients do not exceed the maximum daily dosage of 2 caplets within a 24-hour period. Additionally, patients must avoid concurrent use with other medications containing acetaminophen, as this can further increase the risk of liver injury.

Patients with compromised liver function, including those with liver disease, liver cirrhosis, or other significant health conditions such as high blood pressure or heart disease, should consult a healthcare professional prior to using this product. Furthermore, consumption of three or more alcoholic drinks daily while using this product is contraindicated, as it may exacerbate the risk of liver damage. Regular monitoring of liver function may be warranted in patients with existing liver conditions 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 attention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Healthcare professionals should be aware that the presentation of symptoms may vary, and vigilance is necessary to ensure appropriate management. The potential for serious complications underscores the importance of rapid intervention.

Management procedures should include a thorough assessment of the patient's condition, monitoring vital signs, and providing supportive care as needed. It is essential to follow established protocols for overdose management, which may involve decontamination, administration of antidotes if applicable, and symptomatic treatment.

In summary, the critical nature of overdose situations necessitates immediate action and adherence to medical guidelines to mitigate risks and ensure patient safety.

Nonclinical Toxicology

It is especially important not to use aspirin at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor, as it may cause problems in the unborn child or complications during delivery. No specific non-teratogenic effects or additional nonclinical toxicology details are available in the provided data. Furthermore, there are no specific findings related to animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified several adverse events reported voluntarily or through surveillance programs.

Allergic reactions have been documented, and individuals are advised to seek medical assistance immediately if such reactions occur. Additionally, cases of stomach bleeding have been reported, characterized by symptoms such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain.

Reports also indicate that some patients may not experience relief from migraines or may find their condition worsens following the initial dose. Furthermore, new or unexpected symptoms have been noted in certain individuals. Instances of tinnitus or hearing loss have also been observed.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical help or contact a Poison Control Center (1-800-222-1222) in the event of an overdose, as prompt medical attention is crucial for both adults and children, even if no signs or symptoms are present.

Patients should be informed not to use this medication if they have a history of allergic reactions to acetaminophen, aspirin, or any other pain reliever or fever reducer. It is essential to avoid concurrent use with any other medications containing acetaminophen, whether prescription or nonprescription. If patients are uncertain about the contents of a medication, they should be encouraged to consult a doctor or pharmacist.

Patients must be instructed to discontinue use and consult a doctor if they experience any signs of an allergic reaction or if they notice any of the following symptoms: faintness, vomiting blood, bloody or black stools, stomach pain that does not improve, or if their migraine is not relieved or worsens after the first dose. Additionally, they should seek medical advice if new or unexpected symptoms arise, or if they experience ringing in the ears or loss of hearing.

Before initiating treatment, patients should be advised to consult a doctor if they have never had migraines diagnosed by a healthcare professional, if they have a headache that differs from their usual migraines, or if they are experiencing the worst headache of their life. They should also seek medical advice if they have fever and a stiff neck, headaches that begin after or are caused by head injury, exertion, coughing, or bending, or if they experienced their first headache after the age of 50. Patients with daily headaches or migraines severe enough to require bed rest should also consult a doctor prior to use.

Furthermore, patients with liver disease, a history of stomach problems (such as heartburn), high blood pressure, heart disease, liver cirrhosis, or kidney disease should be advised to seek medical guidance before using this medication. Those taking diuretics, individuals with asthma, or patients who have experienced serious side effects from pain relievers or fever reducers should also consult a healthcare professional before use.

Patients should be encouraged to discuss their current medications with a doctor or pharmacist, especially if they are taking prescription drugs for diabetes, gout, or arthritis, or if they are under care for any serious condition. It is important for patients to inform their healthcare provider about any other drugs or products they are taking that may contain aspirin, acetaminophen, or any other pain reliever or fever reducer.

Storage and Handling

The product is supplied in a configuration that includes specific packaging details, which are essential for proper handling and storage. It is recommended to store the product at a temperature range of 20°-25°C (68°-77°F) to maintain its efficacy.

After each use, it is crucial to close the cap tightly to prevent contamination and ensure the integrity of the product. Users are advised to read all product information thoroughly before use and to retain the packaging for future reference, as it contains important information regarding the product.

Additional Clinical Information

Patients should take 2 caplets with a glass of water, ensuring not to exceed this dosage within a 24-hour period unless directed by a healthcare professional. For individuals under 18 years of age, consultation with a doctor is advised prior to use.

Clinicians should counsel patients who are pregnant or breastfeeding to seek professional advice before use. It is particularly crucial to avoid aspirin after 20 weeks of pregnancy unless specifically instructed by a doctor, as it may pose risks to the unborn child or lead to complications during delivery. Additionally, patients should be reminded to keep the medication out of reach of children and to seek immediate medical assistance or contact a Poison Control Center (1-800-222-1222) in the event of an overdose, as prompt attention is essential for both adults and children, even in the absence of symptoms.

Drug Information (PDF)

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

View product document (PDF)