Pamprin Max Menstrual Pain Relief

Description

The product is a combination of acetaminophen, pamabrom, and caffeine. Acetaminophen is characterized as a white, odorless crystalline powder, while pamabrom appears as a white to off-white crystalline powder. Caffeine is also a white, odorless crystalline powder. The formulation includes several inactive ingredients: anhydrous citric acid, D&C Yellow No. 10, FD&C Red No. 40, magnesium stearate, microcrystalline cellulose, sodium bicarbonate, sodium citrate, starch, talc, titanium dioxide, and other specified ingredients.

Uses and Indications

This drug is indicated for the temporary relief of symptoms associated with menstrual periods, including cramps, headache, backache, fatigue, and bloating.

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

Dosage and Administration

Adults and children aged 12 years and over are instructed to take 2 caplets with water every 6 hours as needed. The maximum allowable dosage is 8 caplets within a 24-hour period, unless otherwise directed by a healthcare professional. It is imperative that patients do not exceed the recommended dosage.

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

Contraindications

Use is contraindicated in patients with a known allergy to aspirin or any other pain reliever or fever reducer. Additionally, concurrent use with any 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 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.

Aspirin, a component of this product, may lead to severe allergic reactions, which can manifest as hives, facial swelling, asthma (wheezing), or shock. Additionally, acetaminophen may cause severe skin reactions, including skin reddening, blisters, and 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, which poses a risk of severe liver damage if the maximum daily dosage of 8 caplets is exceeded within a 24-hour period, if it is taken concurrently with other medications containing acetaminophen, or if consumed with three or more alcoholic drinks daily.

Furthermore, the presence of an NSAID in this product raises the risk of severe stomach bleeding, particularly in individuals aged 60 or older, those with a history of stomach ulcers or bleeding problems, and those taking anticoagulants, steroids, or other NSAIDs (such as aspirin, ibuprofen, or naproxen). The risk is also heightened in individuals who consume three or more alcoholic drinks daily or who exceed the recommended dosage or duration of use.

Caution is advised regarding caffeine intake, as the recommended dose of this product contains approximately the same amount of caffeine as a cup of coffee. It is advisable to limit the use of other caffeine-containing medications, foods, or beverages to avoid potential side effects such as nervousness, irritability, sleeplessness, and, in some cases, rapid heartbeat.

Healthcare professionals should be consulted prior to use if the patient has liver disease, if the stomach bleeding warning is applicable, if there is a history of stomach problems (such as heartburn), or if the patient has high blood pressure, heart disease, liver cirrhosis, or kidney disease. Additionally, patients taking diuretics or prescription medications for gout, diabetes, or arthritis should seek advice from a doctor or pharmacist before using this product.

In the event of an overdose, immediate medical attention is crucial. Patients or caregivers should contact a Poison Control Center or seek emergency medical help without delay, as prompt intervention is essential for both adults and children, even in the absence of noticeable signs or symptoms.

Patients should discontinue use and contact a healthcare professional if any allergic reactions occur, if symptoms indicative of stomach bleeding arise (such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain), if redness or swelling develops, if new symptoms emerge, if pain worsens or persists beyond 10 days, if fever intensifies or lasts more than 3 days, 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 can be serious.

Reye’s syndrome is a rare but serious condition that may occur in children and teenagers who have or are recovering from chickenpox or flu-like symptoms. If patients exhibit 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 allergic reactions may occur, particularly in patients sensitive to aspirin. Symptoms of such reactions can include hives, facial swelling, asthma (wheezing), and shock. Additionally, acetaminophen may lead to severe skin reactions, characterized by skin reddening, blisters, and rash. If any skin reaction occurs, patients are advised to discontinue use and seek medical assistance promptly.

The product contains acetaminophen, which poses a risk of severe liver damage if patients exceed the maximum daily dosage of 8 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.

Furthermore, 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, and individuals taking blood thinners, steroids, or other NSAIDs. Patients who consume three or more alcoholic drinks daily or take the medication for longer than directed are also at increased risk.

Caffeine is another component of this product, and patients are cautioned to limit the intake of other caffeine-containing medications, foods, or beverages. Excessive caffeine consumption may lead to nervousness, irritability, sleeplessness, and, in some cases, rapid heartbeat.

Patients should stop using the product and seek medical advice 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), redness or swelling, new symptoms, worsening pain lasting more than 10 days, fever lasting more than 3 days, or ringing in the ears or loss of hearing.

Before using this product, patients with liver disease, a history of stomach problems (such as heartburn), high blood pressure, heart disease, liver cirrhosis, or kidney disease should consult a doctor. Additionally, pregnant or breastfeeding patients should seek professional advice prior to use, particularly as aspirin may pose risks to the unborn child or complications during delivery if used in the last three months of pregnancy unless specifically directed by a healthcare provider.

Drug Interactions

Concurrent use of this product with any other medication containing acetaminophen, whether prescription or nonprescription, is contraindicated due to the risk of acetaminophen overdose.

Patients taking prescription medications for gout, diabetes, or arthritis should consult a healthcare professional prior to using this product to ensure safety and efficacy.

The concomitant use of blood thinners (anticoagulants) or steroid medications may significantly elevate the risk of severe gastrointestinal bleeding. Close monitoring is advised for patients on these therapies.

Caution is recommended 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.

Additionally, the use of alcohol, sedatives, or tranquilizers in conjunction with this product may enhance drowsiness. Patients should be advised to limit or avoid these substances to prevent excessive sedation.

Packaging & NDC

Below are the non-prescription pack sizes of Pamprin Max Menstrual Pain Relief (acetaminophen and aspirin and 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, 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, children under 12 years of age should consult a doctor before use. For adults and children aged 12 years and older, the recommended dosage is 2 caplets with water every 6 hours as needed, with a maximum of 8 caplets in a 24-hour period, unless otherwise directed by a doctor. It is crucial not to exceed the recommended dosage.

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 anticoagulants or steroid medications, and patients taking other NSAIDs, whether prescription or over-the-counter, such as aspirin, ibuprofen, or naproxen.

Additionally, the risk of gastrointestinal complications may be exacerbated by the consumption of three or more alcoholic drinks daily while using this product, as well as by exceeding the recommended dosage or duration of use. Therefore, careful monitoring and consideration of these factors are essential when prescribing this medication to geriatric patients. Dose adjustments may be necessary based on individual risk profiles to ensure safety and minimize potential adverse effects.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional before using this medication. The use of aspirin during the last trimester of pregnancy is particularly cautioned against, as it may lead to adverse effects on the unborn child or complications during delivery. Therefore, it is essential 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, 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 while breastfeeding.

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, particularly if they have a history of liver disease, liver cirrhosis, high blood pressure, heart disease, or kidney disease.

This product contains acetaminophen, which may pose a risk of severe liver damage in patients with compromised liver function. It is critical for these patients to adhere to the following guidelines to minimize the risk of hepatotoxicity:

• The maximum recommended dosage is 8 caplets within a 24-hour period. Exceeding this limit may increase the risk of liver damage.

• Patients should avoid concomitant use of other medications that contain acetaminophen, as this can lead to cumulative dosing and potential toxicity.

• Consumption of three or more alcoholic drinks per day while using this product is contraindicated, as it may exacerbate the risk of liver injury.

Close monitoring of liver function is advised for patients with hepatic impairment who are prescribed this product.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Prompt medical intervention is crucial for both adults and children, even in the absence of observable 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 care as needed.

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 specific non-teratogenic effects have been identified in the available data. Additionally, there are no details regarding nonclinical toxicology or animal pharmacology and toxicology provided in the text.

Postmarketing Experience

Postmarketing experience has identified several adverse events associated with the use of this product, reported voluntarily or through surveillance programs.

Severe allergic reactions have been noted with aspirin, which may manifest as hives, facial swelling, asthma (wheezing), or shock. Acetaminophen has been associated with severe skin reactions, including symptoms such as skin reddening, blisters, and rash.

Warnings regarding liver damage indicate that severe liver injury may occur if the maximum daily dosage of more than 8 caplets is exceeded within 24 hours, if used concurrently with other acetaminophen-containing products, or if consumed with three or more alcoholic drinks daily.

The product contains an 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, and those taking anticoagulants, steroids, or other NSAIDs. The risk is also heightened with excessive alcohol consumption or prolonged use beyond the recommended duration.

Caffeine content in the recommended dose is comparable to that of a cup of coffee. Caution is advised regarding the concurrent use of other caffeine-containing medications, foods, or beverages, as excessive caffeine intake may lead to nervousness, irritability, sleeplessness, and, occasionally, rapid heartbeat.

Users are advised to discontinue use and consult a healthcare professional if an allergic reaction occurs or if any signs of stomach bleeding are experienced, such as feeling faint, vomiting blood, having bloody or black stools, or persistent stomach pain. Additional symptoms warranting medical attention include redness or swelling, new symptoms, worsening pain lasting more than 10 days, fever lasting more than 3 days, or any ringing in the ears or loss of hearing.

Drowsiness may occur with the use of this product; therefore, users are cautioned to avoid alcoholic beverages and to exercise caution when driving or operating machinery. Excitability has been reported, particularly in children.

Patient Counseling

Healthcare providers should advise patients about the importance of seeking immediate medical assistance in the event of an overdose. Patients should be informed to contact a Poison Control Center or seek medical help right away, as prompt attention is crucial for both adults and children. It is essential to emphasize that even in the absence of noticeable signs or symptoms, medical evaluation is necessary to ensure safety and appropriate care.

Storage and Handling

The product is supplied in a container that must be kept tightly closed to maintain its integrity. It should be stored at room temperature, away from direct light exposure to protect its efficacy. Additionally, it is essential to keep the product out of reach of children. Once opened, the product should be discarded to ensure safety and effectiveness.

Additional Clinical Information

Adults and children aged 12 years and over are advised to take 2 caplets with water every 6 hours as needed, with a maximum of 8 caplets in a 24-hour period unless otherwise directed by a healthcare professional. It is crucial to adhere to the recommended dosage to avoid potential risks.

Patients should be counseled on the possibility of drowsiness when using this product and are advised to avoid alcoholic beverages, as well as sedatives and tranquilizers, which may enhance drowsiness. Caution is recommended when driving or operating machinery. Additionally, excitability may occur, particularly in children.

Drug Information (PDF)

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

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