Sohmed Pain Reliever

Description

SohMed™ is a combination analgesic formulation containing 250 mg of acetaminophen, 250 mg of aspirin (a nonsteroidal anti-inflammatory drug), and 65 mg of caffeine. This product is indicated for the relief of minor aches and pains. Each package contains 24 caplets. SohMed™ is comparable to the active ingredients found in Excedrin®.

Uses and Indications

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

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

Dosage and Administration

Patients should adhere strictly to the recommended dosage and not exceed the directed amount. 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, with a maximum 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 recommendations.

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 medication containing acetaminophen, whether prescription or nonprescription. 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 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.

Although rare, serious skin reactions may occur with the consumption of acetaminophen, including three distinct skin diseases characterized by rash, blisters, and potentially extensive skin damage. Should a rash or any other skin reaction develop while using this product, it is crucial to discontinue use immediately and seek medical attention.

This product contains acetaminophen, and severe liver damage may result from exceeding the following limits: adults should not take more than 8 caplets in a 24-hour period, while children should not exceed 5 caplets in the same timeframe. Additionally, liver damage may occur if this product is taken concurrently with other medications containing acetaminophen, or if the user consumes three or more alcoholic drinks daily while using this product.

The presence of an NSAID in this product raises the risk of severe stomach bleeding, particularly 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.

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 while using this product, as excessive caffeine consumption may lead to symptoms such as nervousness, irritability, sleeplessness, and, in some cases, rapid heartbeat.

Healthcare professionals should advise patients to consult a physician prior to use if they have liver disease, if the stomach bleeding warning is applicable, if they have not been adequately hydrating, if they have a history of gastrointestinal issues such as heartburn, or if they have conditions such as high blood pressure, heart disease, liver cirrhosis, or kidney disease. Patients taking diuretics, those with asthma, or individuals who have experienced significant fluid loss due to vomiting or diarrhea should also seek medical advice before use.

Furthermore, patients should consult a doctor or pharmacist before using this product if they are currently taking any other NSAIDs (whether prescription or over-the-counter), anticoagulants, steroid medications, or prescription drugs for diabetes, gout, or arthritis, or if they are under medical care for any serious condition.

In the event of an overdose, immediate medical assistance should be sought, or a poison control center should be contacted without delay. Prompt medical attention is critical for both adults and children, even in the absence of noticeable signs or symptoms.

Patients should discontinue use and contact a physician if they experience any allergic reactions, or if they exhibit signs of stomach bleeding, which may include feeling faint, vomiting blood, passing bloody or black stools, experiencing persistent stomach pain, or noticing ringing in the ears or loss of hearing. Additionally, if a painful area becomes red or swollen, if pain worsens or persists beyond 10 days, or if fever intensifies or lasts more than 3 days, medical consultation is warranted.

Side Effects

Patients using this product may experience a range of adverse reactions, some of which can be serious.

Serious adverse reactions include the potential for Reye's syndrome, particularly in children and teenagers who have or are recovering from chickenpox or flu-like symptoms. Symptoms such as changes in behavior accompanied by nausea and vomiting may indicate the onset of this rare but serious illness, and medical consultation is advised if these symptoms occur. Additionally, although rare, serious skin reactions may occur with acetaminophen use, manifesting as rash, blisters, or, in severe cases, widespread skin damage. Patients should discontinue use immediately and seek medical attention if any skin reactions develop.

Allergic reactions to aspirin can also be severe, presenting as hives, facial swelling, asthma (wheezing), or shock. Patients experiencing any signs of an allergic reaction should seek medical help promptly.

The product contains acetaminophen, which carries a risk of severe liver damage if the maximum daily dosage is exceeded—more than 8 caplets for adults or 5 caplets for children within 24 hours, or if taken in conjunction with other acetaminophen-containing products. The risk is further heightened in individuals consuming three or more alcoholic drinks daily while using this product.

Stomach bleeding is another serious risk associated with the nonsteroidal anti-inflammatory drug (NSAID) component of this product. The likelihood of severe stomach bleeding increases 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 should be vigilant for signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain.

Common adverse reactions may include nervousness, irritability, sleeplessness, and, occasionally, rapid heartbeat due to caffeine content. Patients are advised to limit the use of other caffeine-containing medications, foods, or beverages while using this product.

Patients should discontinue use and consult a doctor if they experience any of the following: signs of an allergic reaction, symptoms of stomach bleeding, ringing in the ears or loss of hearing, worsening pain lasting more than 10 days, or fever lasting more than 3 days.

It is important to note that this product should not be used by individuals with a known allergy to acetaminophen, aspirin, or any other pain reliever/fever reducer. Prior to use, patients should consult a doctor if they have liver disease, a history of stomach problems, high blood pressure, heart disease, liver cirrhosis, kidney disease, or if they are taking diuretics or other medications that may interact with this product.

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 significantly increases the likelihood of severe gastrointestinal bleeding. Close monitoring for signs of bleeding is recommended in patients receiving these combinations.

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 should be exercised, and the use of multiple NSAIDs should be avoided.

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 Sohmed Pain Reliever (acetaminophen, aspirin, and 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. It is important to consult a healthcare professional if any changes in behavior accompanied by nausea and vomiting occur, as these may be early indicators of Reye's syndrome.

For dosing, the maximum daily amount for children is limited to 5 caplets within a 24-hour period. For children under 12 years of age, it is advised to consult a doctor prior to use. In contrast, for adolescents aged 12 years and older, the recommended dosage is 2 caplets every 6 hours, with a maximum of 8 caplets in a 24-hour period.

Geriatric Use

Elderly patients, particularly those aged 60 and older, may have an increased risk of stomach bleeding associated with the use of this medication. It is essential for healthcare providers to exercise caution when prescribing this treatment to geriatric patients, especially those with a history of gastrointestinal issues, such as heartburn or other stomach problems.

Before initiating therapy, healthcare providers should inquire about any prior gastrointestinal conditions in elderly patients. If the stomach bleeding warning is applicable, a thorough evaluation and consideration of alternative treatment options may be warranted. Close monitoring for signs of gastrointestinal bleeding is recommended in this population to ensure patient safety.

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 fetal development and 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 healthcare professional before using this medication. It is particularly important to avoid the use of aspirin during the last three months of pregnancy unless explicitly 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 in lactating individuals.

Renal Impairment

Patients with renal impairment should consult a healthcare professional prior to use, particularly if they have a history of 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. The presence of acetaminophen in this formulation necessitates caution, as severe liver damage may occur under certain conditions.

For adults, the maximum recommended dosage is 8 caplets within a 24-hour period. Exceeding this limit can significantly increase the risk of liver injury. In pediatric patients, the maximum dosage is limited to 5 caplets in a 24-hour period.

Additionally, patients should be advised against the concurrent use of other medications containing acetaminophen, as this can further elevate the risk of hepatotoxicity. Consumption of 3 or more alcoholic beverages daily while using this product is also contraindicated, as it may exacerbate the potential for severe liver damage. Regular monitoring of liver function may be warranted in patients with compromised liver function who require acetaminophen-containing products.

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

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 current information.

Postmarketing Experience

Postmarketing experience has identified several serious adverse reactions associated with the use of this product. Although rare, serious skin diseases have been reported, characterized by symptoms such as rash and blisters, which can lead to extensive damage to the skin's surface. Users are advised to discontinue use and seek medical attention if any skin reactions occur.

Additionally, there is an allergy alert indicating that aspirin may trigger severe allergic reactions, including hives, facial swelling, asthma (wheezing), and shock.

Severe liver damage has been noted in cases where individuals exceed the maximum recommended dosage of 8 caplets in 24 hours, or if a child consumes more than 5 caplets in the same timeframe. The risk of liver damage is also heightened when acetaminophen is taken in conjunction with other medications containing acetaminophen or when combined with the consumption of 3 or more alcoholic drinks daily.

The product contains a nonsteroidal anti-inflammatory drug (NSAID), which may lead to severe stomach bleeding. The risk is increased 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 likelihood of stomach bleeding is also elevated in individuals who consume 3 or more alcoholic drinks daily while using the product or who exceed the recommended duration or dosage.

In the event of an overdose, it is crucial to seek immediate medical assistance or contact a poison control center, as prompt medical attention is essential for both adults and children, even in the absence of noticeable signs or symptoms.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. Patients must be informed not to use the medication if they have ever experienced an allergic reaction to acetaminophen, aspirin, or any other pain reliever or fever reducer.

It is crucial to instruct patients not to use this medication in conjunction with any drug containing acetaminophen, whether prescription or nonprescription. If patients are uncertain whether a drug contains acetaminophen, they should be encouraged to consult a doctor or pharmacist for clarification.

Patients should be advised to stop using the medication and seek medical attention immediately if they experience any signs of an allergic reaction. Additionally, they should be informed to discontinue use and consult a doctor 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. Other concerning symptoms include ringing in the ears or loss of hearing, redness or swelling in a painful area, worsening pain lasting more than 10 days, or a fever that worsens or lasts more than 3 days.

Healthcare providers should recommend that patients consult a doctor before using this medication if they have liver disease or if the stomach bleeding warning applies to them. Patients should also be advised to seek medical advice if they have not been adequately hydrating, have a history of stomach problems such as heartburn, or have conditions such as high blood pressure, heart disease, liver cirrhosis, or kidney disease.

Furthermore, patients should be encouraged to consult a doctor before use if they are taking a diuretic, have asthma, or have lost significant fluids due to vomiting or diarrhea. It is also important to advise patients to speak with a doctor or pharmacist before using this medication if they are taking any other drug containing a nonsteroidal anti-inflammatory drug (NSAID), a blood-thinning (anticoagulant) or steroid drug, or a prescription medication for diabetes, gout, or arthritis. Lastly, patients should be reminded to consult a doctor or pharmacist if they are taking any other medications or are under a doctor's care for any serious condition.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers, which can be found on the packaging. It is essential to store the product at a controlled room temperature ranging from 20° to 25°C (68° to 77°F).

Healthcare professionals should refer to the end flap of the packaging for the expiration date and lot number to ensure proper tracking and usage. Special handling requirements are not specified; however, maintaining the recommended temperature range is crucial for product integrity.

Additional Clinical Information

The medication is administered orally. For adults and children aged 12 years and older, the recommended dosage is 2 caplets every 6 hours, 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 regarding appropriate dosing.

There is no additional information available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

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

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