Migraine Relief

Description

Caring Mill™ Migraine Relief is formulated as a combination of Acetaminophen, Aspirin (NSAID), and Caffeine, designed to provide effective relief from migraine symptoms. Each dosage form consists of capsule-shaped, coated tablets, with a total of 100 tablets per container. The product is identified by the National Drug Code (NDC) 81522-205-03 and is comparable to the active ingredients found in Excedrin® Migraine. It serves as a pain reliever and pain reliever aid, targeting the discomfort associated with migraines.

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 caplets with a full glass of water. It is essential that no more than 2 caplets are taken within a 24-hour period unless otherwise directed by a healthcare professional. In the event that symptoms persist or worsen, patients should consult their doctor for further evaluation and guidance.

For individuals under 18 years of age, it is recommended to seek advice from a healthcare provider before use. It is imperative to adhere strictly to the recommended dosage and not exceed the directed amount.

Contraindications

Use is contraindicated in patients with a history of allergic reactions to acetaminophen, aspirin, or any other pain reliever/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 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.

Acetaminophen, a component of this product, has the potential to cause severe skin reactions. Symptoms may include skin reddening, blisters, or rash. Should any skin reaction occur, the use of the product must be discontinued immediately, and medical assistance should be sought.

This product contains acetaminophen, and severe liver damage may result from exceeding the maximum daily dosage of 2 caplets within a 24-hour period, using it concurrently with other medications containing acetaminophen, or consuming three or more alcoholic beverages daily while using this product.

Additionally, the product contains a nonsteroidal anti-inflammatory drug (NSAID), which may lead to severe stomach bleeding. The risk of such complications 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 duration or dosage of the product.

Prolonged use of this product, specifically for 10 or more days per month, may exacerbate headaches. The recommended dosage contains approximately the same amount of caffeine as a cup of coffee. Therefore, it is advisable to limit the intake of other caffeine-containing medications, foods, or beverages during treatment, as excessive caffeine consumption may lead to nervousness, irritability, sleeplessness, and, in some cases, rapid heartbeat.

Individuals with a known allergy to acetaminophen, aspirin, or any other pain reliever or fever reducer should refrain from using this product. It is also crucial to avoid concurrent use with any other medications containing acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in a medication, consultation with a healthcare professional is recommended.

In the event of an overdose, immediate medical assistance should be sought, 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.

Patients should discontinue use and contact a healthcare provider if they experience any signs of an allergic reaction, symptoms indicative of stomach bleeding (such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain), if their migraine is not alleviated or worsens after the first dose, if new or unexpected symptoms arise, or if they experience 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 may occur in children and teenagers who have or are recovering from chickenpox or flu-like symptoms. If patients experience changes in behavior accompanied by nausea and vomiting while using this product, they should consult a doctor immediately, as these symptoms could indicate the onset of Reye's syndrome.

Severe skin reactions have been reported with acetaminophen, which may manifest as skin reddening, blisters, or rash. If any skin reaction occurs, patients are advised to discontinue use and seek medical assistance promptly. Additionally, aspirin may provoke severe allergic reactions, including hives, facial swelling, asthma (wheezing), and shock.

The product contains acetaminophen, and patients should be cautious as severe liver damage may occur if they 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.

Patients should also be aware that the product contains a nonsteroidal anti-inflammatory drug (NSAID), which may increase the 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 blood thinners or other NSAIDs. The risk is further heightened with excessive alcohol consumption or prolonged use beyond the recommended duration.

Medication overuse headaches may occur if this product is used for 10 or more days per month. Furthermore, the recommended dose contains caffeine equivalent to that of a cup of coffee, and patients should limit the intake of other caffeine-containing products to avoid symptoms such as nervousness, irritability, sleeplessness, and, occasionally, rapid heartbeat.

Patients are advised to stop use and consult a doctor if they experience any signs of an allergic reaction, symptoms indicative of stomach bleeding (such as feeling faint, vomiting blood, or having bloody or black stools), if their migraine is not relieved or worsens after the first dose, or if new or unexpected symptoms arise, including ringing in the ears or loss of hearing.

Before using this product, patients should seek medical advice if they have never had migraines diagnosed by a healthcare professional, if they experience headaches that differ from their usual migraines, or if they have any of the following conditions: fever and stiff neck, headaches following head injury, daily headaches, severe migraines requiring bed rest, liver disease, or a history of stomach problems. Additionally, those with high blood pressure, heart disease, liver cirrhosis, kidney disease, or who are taking diuretics should consult a doctor prior to use.

Patients taking prescription medications for diabetes, gout, or arthritis, or those under a doctor's care for any serious condition, should also seek advice before using this product. It is important to inform healthcare providers about any other medications or products containing aspirin, acetaminophen, or other pain relievers/fever reducers being taken concurrently.

Drug Interactions

Co-administration of this product with any other drug containing acetaminophen, whether prescription or nonprescription, is contraindicated due to the risk of acetaminophen overdose.

Pharmacodynamic interactions are significant when this product is used alongside anticoagulants or steroid medications. The concomitant use of these agents increases the risk of severe gastrointestinal bleeding. Similarly, the use of this product with other nonsteroidal anti-inflammatory drugs (NSAIDs), including aspirin, ibuprofen, and naproxen, also heightens the risk of severe stomach bleeding.

Patients taking prescription medications for diabetes, gout, or arthritis should consult a healthcare professional prior to using this product to ensure safe co-administration.

Caution is advised regarding the intake of caffeine-containing medications, foods, or beverages while using this product. Excessive caffeine consumption may lead to adverse effects such as nervousness, irritability, insomnia, and, in some cases, tachycardia. Monitoring of caffeine intake is recommended to mitigate these potential effects.

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

Packaging & NDC

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

Pediatric Use

Pediatric patients, including children and teenagers, should not use this product if they have or are recovering from chicken pox or flu-like symptoms. It is important to consult a doctor if any changes in behavior accompany nausea and vomiting, as these symptoms may indicate the onset of Reye’s syndrome, a rare but serious condition. For individuals under 18 years of age, it is advised to seek medical guidance prior to use.

Geriatric Use

Elderly patients, particularly those aged 60 years and older, may have an increased risk of severe stomach bleeding. It is essential for healthcare providers to exercise caution when prescribing this medication to geriatric patients.

Monitoring for signs and symptoms of gastrointestinal bleeding is advised, and dosage adjustments may be necessary based on the individual patient's health status and concurrent medications. Careful assessment of the risks versus benefits should be conducted to ensure the safety of elderly patients receiving this treatment.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to use. 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, particularly in the later stages of pregnancy.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication if they are pregnant or breastfeeding. It is particularly important to avoid the use of aspirin at 20 weeks of pregnancy or later unless specifically directed by a healthcare provider, as it may pose risks to the unborn child or lead to complications during delivery. There is no available data regarding the excretion of this medication in breast milk or its effects on breastfed infants.

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, which contains acetaminophen. Severe liver damage may occur if patients exceed the maximum daily dosage of 2 caplets within a 24-hour period. Additionally, patients should avoid concomitant use with other medications containing acetaminophen, as this may further increase the risk of liver injury.

It is also advised that patients limit alcohol consumption to fewer than 3 drinks per day while using this product, as excessive alcohol intake can exacerbate the potential for liver damage.

Before initiating treatment, patients with known liver disease should consult a healthcare professional to assess the appropriateness of this product for their condition. Regular monitoring of liver function may be warranted in these patients to ensure safety and efficacy.

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, vigilance and timely action are essential in managing overdose situations effectively.

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 reactions reported voluntarily or through surveillance programs. These include allergic reactions such as hives, facial swelling, asthma (wheezing), and shock. Severe skin reactions associated with acetaminophen have also been noted, including skin reddening, blisters, and rash. Instances of liver damage due to excessive acetaminophen intake have been reported.

Additionally, stomach bleeding has been observed, particularly in individuals over 60 years of age or those with a history of stomach ulcers or bleeding problems. Medication overuse headaches have been documented as a consequence of prolonged use. New or unexpected symptoms occurring after use have been reported, along with instances of ringing in the ears or loss of hearing.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children. In the event of an overdose, patients should be instructed to seek medical help or contact a Poison Control Center immediately at 1-800-222-1222, as prompt medical attention is crucial for both adults and children, even if no signs or symptoms are apparent.

Patients should be informed to discontinue use and consult a doctor if they experience any signs of an allergic reaction, and to seek immediate medical assistance in such cases. Additionally, they should be cautioned to stop use and contact a healthcare professional if they notice any symptoms indicative of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain.

Patients should also be advised to stop use and consult a doctor if their migraine is not alleviated or worsens after the first dose, or if they develop new or unexpected symptoms. They should be made aware that ringing in the ears or loss of hearing warrants immediate consultation with a healthcare provider.

Before using the medication, patients should be encouraged to discuss their medical history with their healthcare provider, particularly if they have never had migraines diagnosed by a health professional, if they experience headaches that differ from their usual migraines, or if they have the worst headache of their life. They should also seek medical advice if they have a fever and 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 should be advised to consult a doctor before use if they have daily headaches, a migraine so severe that it requires bed rest, liver disease, or if the stomach bleeding warning applies to them. They should also discuss any history of stomach problems, such as heartburn, and any conditions like high blood pressure, heart disease, liver cirrhosis, or kidney disease.

Furthermore, patients should be encouraged to seek medical advice before use if they are taking a diuretic, have asthma, or have experienced serious side effects from pain relievers or fever reducers. If they experience vomiting with their migraine headache, they should consult a doctor. Patients should also be advised to speak with a doctor or pharmacist before using the medication if they are taking prescription drugs for diabetes, gout, or arthritis, are under a doctor’s care for any serious condition, or are taking any other medications or products that contain aspirin, acetaminophen, or any other pain reliever or fever reducer.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers, which are essential for identification and inventory management. It is recommended to store the product at a controlled room temperature ranging from 20º to 25ºC (68º to 77ºF) to ensure its stability and efficacy.

After each use, it is crucial to close the cap tightly to maintain the integrity of the product and prevent contamination. Proper adherence to these storage and handling guidelines will help ensure optimal performance and safety.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients who are pregnant or breastfeeding to consult a healthcare 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. No further information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

Drug Information (PDF)

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

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