Dg Health Migraine Relief

Description

Acetaminophen, Aspirin (NSAID), and Caffeine Tablets are formulated as gelatin-coated tablets designed for pain relief. Each tablet serves as a pain reliever and pain reliever aid, providing a combination of active ingredients to address discomfort. The product is available in a package containing 80 geltabs, with the actual size of each geltab specified.

Uses and Indications

This drug is indicated for the treatment of migraine.

There are no teratogenic effects associated with this medication. Additionally, no nonteratogenic effects have been reported.

Dosage and Administration

Adults are instructed to take 2 geltabs with a full glass of water. It is essential not to exceed the recommended dosage of 2 geltabs within a 24-hour period unless otherwise directed by a healthcare professional. In cases where symptoms persist or worsen, patients should consult their doctor for further evaluation and guidance.

For individuals under 18 years of age, it is advised to seek medical advice before administration.

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 has been associated with severe skin reactions. Symptoms may include skin reddening, blisters, or rash. Should any of these reactions occur, the use of the product must be discontinued immediately, and medical assistance should be sought without delay.

Additionally, aspirin 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 manifest.

Liver Warning The presence of acetaminophen in this product necessitates caution, as severe liver damage can occur under certain conditions. This includes exceeding the maximum daily dosage of 2 geltabs 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.

Stomach Bleeding Warning As this product contains a nonsteroidal anti-inflammatory drug (NSAID), there is a risk of severe stomach bleeding, particularly in individuals aged 60 or older, those with a history of stomach ulcers or bleeding problems, or those taking anticoagulants or steroid medications. The risk is further elevated with the concurrent use of other NSAIDs (including aspirin, ibuprofen, or naproxen), excessive alcohol consumption (three or more drinks daily), or prolonged use beyond the recommended duration.

Medication Overuse Headache Warning Frequent use of this product, defined as 10 or more days per month, may lead to worsening headaches.

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

Emergency Medical Help In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center at 1-800-222-1222.

Discontinuation of Use Patients 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 migraines 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 may experience a range of adverse reactions, some of which may be serious.

Warnings 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 under these circumstances. If changes in behavior accompanied by nausea and vomiting occur, it is essential to consult a doctor, as these may be early signs of Reye’s syndrome.

Severe skin reactions may occur due to acetaminophen, with symptoms including skin reddening, blisters, and rash. If any skin reaction is observed, patients should discontinue use and seek medical assistance immediately. Aspirin may also cause 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 amount of 2 geltabs within 24 hours, use other medications containing acetaminophen, or consume three or more alcoholic drinks daily while using this product. Additionally, the presence of an NSAID in the formulation may lead to 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 of stomach bleeding is also heightened with excessive alcohol consumption or prolonged use beyond the recommended duration.

Patients should be aware that headaches may worsen if this product is used for 10 or more days per month, a condition known as medication overuse headache. Furthermore, the recommended dose contains caffeine equivalent to a cup of coffee, and excessive caffeine intake may result in severe nervousness, irritability, sleeplessness, and, occasionally, rapid heartbeat.

Stop Use and Consult a Doctor Patients should discontinue use and seek medical advice if they experience any signs of an allergic reaction, such as hives or swelling. Signs of stomach bleeding, including feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain, warrant immediate medical attention. If a migraine is not relieved or worsens after the first dose, or if new or unexpected symptoms arise, patients should consult a healthcare professional. Additionally, any occurrence of ringing in the ears or loss of hearing should be reported to a doctor.

Additional Adverse Reactions or Important Notes Before using this product, patients should consult a doctor if they have never had migraines diagnosed by a healthcare professional, experience headaches that differ from their usual migraines, or have the worst headache of their life. Other concerning symptoms include fever and stiff neck, headaches following head injury, exertion, coughing, or bending, first headaches occurring after age 50, daily headaches, or migraines severe enough to require bed rest. Patients with liver disease, a history of stomach problems, high blood pressure, heart disease, liver cirrhosis, kidney disease, or those taking diuretics or experiencing serious side effects from pain relievers or fever reducers should also seek medical advice prior to use.

Drug Interactions

Concurrent use of this product with other medications containing acetaminophen is contraindicated due to the potential for hepatotoxicity. Additionally, the use of this product alongside other prescription or nonprescription nonsteroidal anti-inflammatory drugs (NSAIDs), such as aspirin, ibuprofen, or naproxen, is not recommended, as it may increase the risk of gastrointestinal bleeding and other adverse effects.

Patients taking anticoagulants or steroid medications should consult a healthcare professional prior to using this product to ensure safe co-administration and to evaluate the need for dosage adjustments or enhanced monitoring.

Furthermore, it is advisable to limit the intake of caffeine-containing medications, foods, or beverages while using this product to avoid potential overstimulation and related side effects.

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

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

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, a rare but serious illness. If any changes in behavior accompanied by nausea and vomiting occur while using this product, it is essential to consult a healthcare professional, as these may be early signs of Reye’s syndrome.

This product should be kept out of reach of children. Quick medical attention is critical for both adults and pediatric patients, even in the absence of noticeable signs or symptoms. For individuals 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 this medication to geriatric patients to mitigate potential risks and optimize therapeutic outcomes.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional before using this medication. It is particularly important to avoid the use of aspirin at 20 weeks of gestation or later unless explicitly directed by a physician, as it may pose risks to the developing fetus and lead to complications during delivery. Healthcare providers should carefully evaluate the potential benefits and risks when considering the use of this medication in pregnant patients.

Lactation

Lactating mothers are advised to consult a health professional before using this medication. It is particularly important to avoid the use of aspirin at 20 weeks of pregnancy 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 its use during lactation.

Renal Impairment

Patients with renal impairment may require careful consideration regarding dosing adjustments and monitoring. In individuals with reduced kidney function, particularly those with high blood pressure, heart disease, liver cirrhosis, or kidney disease, it is essential to assess renal function prior to initiating treatment. Regular monitoring of renal parameters is recommended to ensure safety and efficacy. Adjustments to the dosing regimen may be necessary based on the degree of renal impairment to mitigate the risk of adverse effects and optimize therapeutic outcomes.

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 geltabs within a 24-hour period. Additionally, patients must avoid concurrent use with other medications containing acetaminophen and limit alcohol consumption to fewer than 3 alcoholic drinks per day while using this product.

Before initiating treatment, patients with liver disease or any history of liver dysfunction should consult a healthcare professional. This recommendation extends to individuals with high blood pressure, heart disease, liver cirrhosis, or kidney disease, as these conditions may further complicate the safe use of this product. Regular monitoring of liver function may be warranted in patients with compromised liver health to prevent potential adverse effects.

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 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, it is essential to monitor the patient closely and provide appropriate medical care as needed.

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 relevant information regarding non-teratogenic effects, carcinogenicity, mutagenicity, or animal pharmacology and toxicology has been extracted.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions associated with the use of this product. Severe skin reactions, including skin reddening, blisters, rash, hives, and facial swelling, have been reported in association with acetaminophen. Additionally, severe allergic reactions linked to aspirin may manifest as asthma (wheezing) and shock.

The use of this product, which contains a nonsteroidal anti-inflammatory drug (NSAID), has been associated with stomach bleeding. Medication overuse headache has also been reported, particularly in individuals using the product for 10 or more days per month, which may exacerbate the condition.

Other reported events include new or unexpected symptoms occurring after use, as well as tinnitus or hearing loss. Symptoms indicative of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, and persistent stomach pain, have been noted. Liver damage has been associated with acetaminophen use, and headaches may worsen or remain unresolved after the initial dose.

It is important to seek immediate medical attention for both adults and children in the event of an overdose, even if no signs or symptoms are present.

Patient Counseling

Healthcare providers should advise patients on the importance of seeking immediate medical assistance in the event of an overdose. Patients should be informed to contact a Poison Control Center at 1-800-222-1222 without delay.

It is crucial for patients to understand that quick medical attention is essential for both adults and children, even if they do not exhibit any noticeable signs or symptoms of overdose. Emphasizing this point can help ensure timely intervention and potentially mitigate serious health risks.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers, which should be referenced for accurate identification. It is essential to store the product at a controlled temperature range of 20°-25°C (68°-77°F) to maintain its efficacy and safety.

After each use, the cap must be closed 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

The medication is administered orally. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. It is particularly crucial to avoid the use of aspirin after 20 weeks of pregnancy unless explicitly 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 Dg Health Migraine Relief, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)