Extra Strength Headache, Lil Drug Store

Description

Extra Strength Headache Relief is a formulation manufactured by Lil' Drug Store, designed for the effective relief of headache pain. Each caplet contains 250 mg of acetaminophen, 250 mg of aspirin, and 65 mg of caffeine, collectively functioning as pain relievers and pain reliever aids. The product is presented in a caplet dosage form, with a total quantity of 50 caplets packaged in 25 pouches, each containing 2 caplets. The actual size of the caplets is indicated in the product specifications.

Uses and Indications

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

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

Dosage and Administration

Patients should adhere strictly to the recommended dosage. Each dose should be taken with a full glass of water to ensure proper administration.

For adults and children aged 12 years and older, the recommended dosage is 2 caplets every 6 hours as needed, with a maximum limit of 8 caplets within a 24-hour period.

For children under 12 years of age, it is advised to consult a physician for appropriate dosing guidance.

The medication is intended for oral administration in the form of caplets, and the frequency of administration is every 6 hours as required.

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, a rare but serious illness. If any changes in behavior accompanied by nausea and vomiting occur while using this product, it is imperative to consult a healthcare professional immediately.

Acetaminophen, a component of this product, may lead to severe skin reactions, including symptoms such as skin reddening, blisters, and rash. Should any skin reaction manifest, the use of the product must be discontinued, and medical assistance should be sought without delay.

Aspirin, classified as a nonsteroidal anti-inflammatory drug (NSAID), may provoke severe allergic reactions characterized by hives, facial swelling, asthma (wheezing), or shock. Immediate medical attention is warranted if such symptoms occur.

This product contains acetaminophen, and caution is advised due to the potential for severe liver damage. This risk is heightened if the maximum daily dosage of 8 caplets is exceeded, if other medications containing acetaminophen are taken concurrently, or if the individual consumes three or more alcoholic drinks daily while using this product.

The presence of an NSAID in this formulation raises concerns regarding stomach bleeding, particularly in individuals aged 60 or older, those with a history of stomach ulcers or bleeding disorders, or those concurrently using blood thinners or steroids. The risk is also increased with the use of other NSAIDs (including aspirin, ibuprofen, or naproxen) or if the product is taken in excess or for an extended duration. Alcohol consumption of three or more drinks daily while using this product further elevates this risk.

Caffeine is also present in the recommended dosage of this product, which is comparable to that found in a cup of coffee. It is advisable to 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.

Healthcare professionals should advise patients to consult a doctor prior to use if they have liver disease, if the stomach bleeding warning is applicable, or if they have a history of stomach issues such as heartburn. Additionally, individuals with high blood pressure, heart disease, liver cirrhosis, kidney disease, or those taking diuretics or who have asthma should seek medical advice before using this product. Patients should also 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.

In the event of an overdose, immediate medical assistance should be sought, or contact with a Poison Control Center (1-800-222-1222) is recommended. 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 healthcare professional if they experience any allergic reactions or any of the following signs indicative of stomach bleeding: feeling faint, vomiting blood, having bloody or black stools, experiencing persistent stomach pain, or if there is ringing in the ears or loss of hearing. Additionally, if a painful area becomes red or swollen, if pain worsens or lasts longer than 10 days, if fever intensifies or persists beyond three days, or if any new symptoms arise, medical consultation is necessary, as these may signify a serious condition.

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 against using this product under these circumstances. If changes in behavior accompanied by nausea and vomiting occur, it is essential to consult a healthcare professional, as these may be early signs of Reye's syndrome.

Severe allergic reactions may occur, particularly in patients sensitive to acetaminophen or aspirin (NSAIDs). Symptoms of severe skin reactions associated with acetaminophen may include skin reddening, blisters, and rash. In the event of a skin reaction, patients should discontinue use and seek medical assistance immediately. Aspirin may cause severe allergic reactions characterized by hives, facial swelling, asthma (wheezing), and shock.

This product contains acetaminophen, and patients should be cautioned that severe liver damage may occur if they exceed the maximum daily amount of 8 caplets in 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 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 blood thinners, steroids, or other NSAIDs. Patients should be advised to avoid consuming three or more alcoholic drinks daily while using this product and to adhere strictly to the recommended dosage.

Common Adverse Reactions Patients may also experience less severe but notable reactions. 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, occasionally, rapid heartbeat.

Patients should be instructed to stop use and consult 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 persistent stomach pain), ringing in the ears or loss of hearing, redness or swelling in a painful area, worsening pain lasting more than 10 days, fever lasting more than 3 days, or any new symptoms. These could indicate a serious condition requiring medical evaluation.

Drug Interactions

Co-administration of this product with other medications containing acetaminophen, whether prescription or nonprescription, may result in severe liver damage. It is advisable to avoid the concurrent use of these agents to mitigate this risk.

The concomitant use of this product with anticoagulants or steroid medications may significantly increase the risk of severe gastrointestinal bleeding. Close monitoring for signs of bleeding is recommended, and dosage adjustments may be necessary based on clinical judgment.

Additionally, the use of this product alongside other nonsteroidal anti-inflammatory drugs (NSAIDs), including aspirin, ibuprofen, and naproxen, may elevate the risk of stomach bleeding. Caution is warranted, and it is recommended to limit the use of NSAIDs during treatment.

Patients are also advised to limit the intake of caffeine-containing medications, foods, or beverages while using this product to prevent excessive caffeine consumption.

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

Packaging & NDC

Below are the non-prescription pack sizes of Extra Strength Headache, Lil Drug Store (extra strenght headache relief- acetaminophen, aspirin, caffeine tablet). 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 may be early signs of Reye's syndrome.

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

This product should be kept out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center (1-800-222-1222) without delay, as prompt medical attention is critical for both adults and children, even if no signs or symptoms are apparent.

Geriatric Use

Elderly patients, particularly those aged 60 and older, are at an increased risk of severe stomach bleeding when using this product, which contains a nonsteroidal anti-inflammatory drug (NSAID). This risk is further heightened in individuals with a history of stomach ulcers or bleeding problems, those who are concurrently using blood thinners (anticoagulants) or steroid medications, and patients taking other NSAIDs, whether prescription or over-the-counter, such as aspirin, ibuprofen, or naproxen.

Healthcare providers should exercise caution when prescribing this product to geriatric patients, especially if they consume three or more alcoholic drinks daily while using the medication. It is essential to monitor these patients closely for any signs of gastrointestinal bleeding and to consider dose adjustments or alternative therapies as necessary. Additionally, patients should be advised to adhere strictly to the recommended dosage and duration of use to minimize the risk of adverse effects.

Pregnancy

Pregnant patients and those 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, it may lead to adverse effects on fetal outcomes or complications during delivery. Therefore, it is crucial that pregnant patients only use aspirin under the guidance of a qualified 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 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 consult a healthcare professional prior to using this product. It is important to note that this product contains acetaminophen, which carries a risk of severe liver damage under certain conditions. Specifically, patients should be aware that exceeding the maximum daily dosage of 8 caplets within a 24-hour period may lead to significant liver injury.

Additionally, the concurrent use of other medications containing acetaminophen is contraindicated, as this can further increase the risk of hepatotoxicity. Patients who consume three or more alcoholic beverages daily should exercise caution and seek medical advice before using this product, as alcohol can exacerbate the potential for liver damage when combined with acetaminophen.

Monitoring of liver function may be warranted in patients with compromised liver function who are considering the use of 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 intervention is essential for both adults and children, even in the absence of noticeable signs or symptoms.

Healthcare professionals should be aware that the timely administration of appropriate medical care can significantly influence the outcome of an overdose situation. Monitoring and supportive care may be necessary, depending on the specific circumstances and the substance involved. It is crucial to remain vigilant and proactive in managing potential overdose cases to ensure patient safety and effective treatment.

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 is available regarding non-teratogenic effects. Additionally, there is no relevant information provided concerning nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions associated with the use of acetaminophen and aspirin (NSAIDs). Reports indicate occurrences of severe skin reactions, which include skin reddening, blisters, and rash linked to acetaminophen. Additionally, severe allergic reactions have been reported in association with aspirin, manifesting as hives, facial swelling, asthma (wheezing), and shock. These events were reported voluntarily or through surveillance programs and are documented in the postmarketing safety database.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. In the event of an overdose, patients must be instructed to seek medical help immediately or contact a Poison Control Center 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 medical assistance without delay. Additionally, they should be made aware of the signs of potential stomach bleeding, which include feeling faint, vomiting blood, having bloody or black stools, experiencing persistent stomach pain, noticing ringing in the ears or loss of hearing, observing redness or swelling in a painful area, or if pain worsens or lasts longer than 10 days. Patients should also be advised to seek medical attention if a fever worsens or lasts more than 3 days, or if any new symptoms arise, as these could indicate a serious condition.

Before initiating use, patients should be encouraged to consult a doctor if they have liver disease, a history of stomach problems such as heartburn, or if the stomach bleeding warning applies to them. It is also important for patients to discuss their medical history with a healthcare provider if they have high blood pressure, heart disease, liver cirrhosis, or kidney disease. Patients taking diuretics, those with asthma, or individuals on prescription medications for diabetes, gout, or arthritis should also be advised to consult a doctor or pharmacist prior to use. Furthermore, patients should be reminded to inform their healthcare provider about any other medications they are taking or if they are under care for any serious condition.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at a temperature range of 68°-77°F (20°-25°C). Temporary excursions are permissible between 59°-86°F (15°-30°C).

Care should be taken to avoid exposure to excessive heat and humidity to maintain product integrity. Proper storage conditions are crucial for ensuring the efficacy and safety 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 caplets every 6 hours as needed, not exceeding 8 caplets in a 24-hour period. For children under 12 years, it is advised to consult a doctor for appropriate dosing.

Clinicians should counsel patients on the importance of consulting a health professional if they are pregnant or breastfeeding, particularly regarding the use of aspirin after 20 weeks of pregnancy due to potential risks to the unborn child and complications during delivery. Patients should also be informed to keep the medication out of reach of children and to seek immediate medical assistance or contact a Poison Control Center in the event of an overdose, as prompt attention is crucial for both adults and children, even in the absence of symptoms.

Drug Information (PDF)

This file contains official product information for Extra Strength Headache, Lil Drug Store, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)