Sohmed Extra Strength

Description

SohMed™ is an extra strength formulation containing acetaminophen as the active ingredient, providing effective pain relief and fever reduction. Each caplet contains 500 mg of acetaminophen and is designed for individuals seeking a non-aspirin option for pain management. The product is available in a package containing 24 caplets. This formulation is comparable to the active ingredient found in Extra Strength Tylenol® Caplets.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various conditions, including the common cold, headache, backache, minor pain of arthritis, toothache, muscular aches, and premenstrual and menstrual cramps. Additionally, it is indicated for the temporary reduction of fever.

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 every 6 hours as needed while symptoms persist. The maximum allowable dosage is 6 caplets within a 24-hour period, unless otherwise directed by a healthcare professional. Additionally, the use of this medication should not exceed 10 days unless specifically advised by a doctor.

For children under 12 years of age, it is recommended to consult a healthcare professional for appropriate dosing guidance.

Contraindications

Use of this product is contraindicated in the following situations:

• Co-administration with any other drug containing acetaminophen, whether prescription or nonprescription, is prohibited due to the risk of acetaminophen overdose. If there is uncertainty regarding the presence of acetaminophen in other medications, consultation with a healthcare professional is advised.

• This product should not be used in individuals with a known allergy to acetaminophen or any of the inactive ingredients contained in the formulation, as this may lead to severe allergic reactions.

Warnings and Precautions

This product contains acetaminophen, and it is crucial to adhere to the recommended dosage to prevent severe liver damage. The maximum daily dose is 6 caplets (3,000 mg) within a 24-hour period. Taking more than 4,000 mg of acetaminophen in 24 hours, using other medications that contain acetaminophen concurrently, or consuming three or more alcoholic drinks daily while using this product significantly increases the risk of liver damage.

Although rare, serious skin reactions may occur with acetaminophen use. Symptoms of these reactions can include rash, blisters, and, in severe cases, extensive damage to the skin's surface. If a rash or any other skin reaction develops while taking this product, it is imperative to discontinue use immediately and seek medical attention.

Healthcare professionals should advise patients to consult a doctor prior to use if they have a history of liver disease. Additionally, patients taking the anticoagulant warfarin should seek guidance from a doctor or pharmacist before using this product, as interactions may occur.

In the event of an overdose, immediate medical assistance is essential. Patients should contact a Poison Control Center at 1-800-222-1222 or seek emergency medical help without delay, even if no symptoms are apparent, as prompt intervention is critical for both adults and children.

Patients should also be instructed to stop using this product and consult a doctor if any of the following occur: pain worsens or persists for more than 10 days, fever intensifies or lasts longer than 3 days, new symptoms arise, or if there is any redness or swelling, as these may indicate a serious condition.

Side Effects

Patients using this product should be aware of the potential for serious adverse reactions, particularly related to liver health. The product contains acetaminophen, and exceeding the maximum daily dose of 6 caplets (3,000 mg) can lead to severe liver damage. This risk increases significantly if patients take more than 4,000 mg of acetaminophen in 24 hours, use other medications containing acetaminophen, or consume three or more alcoholic drinks daily while using this product.

In rare instances, patients may experience serious skin reactions associated with acetaminophen use. Symptoms may include rash, blisters, and, in severe cases, widespread damage to the skin's surface. Should any skin reaction occur, patients are advised to discontinue use immediately and seek medical attention.

Patients should not use this product in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription, and should consult a healthcare professional if uncertain about the presence of acetaminophen in other medications. Additionally, individuals with known allergies to acetaminophen or any inactive ingredients in this product should avoid its use.

Before using this product, patients with liver disease should consult a doctor. Furthermore, those taking the blood-thinning medication warfarin should seek advice from a healthcare professional prior to use.

Patients are advised to stop using the product and consult a doctor if pain worsens or persists for more than 10 days, if fever worsens or lasts more than 3 days, if new symptoms arise, or if redness or swelling occurs, as these may indicate a serious condition.

In the event of an overdose, which may result in liver damage, immediate medical assistance should be sought. Patients are encouraged to 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 present.

Drug Interactions

Patients should consult a healthcare professional prior to using this medication if they are concurrently taking warfarin, a blood-thinning agent. The combination may increase the risk of bleeding due to potential pharmacodynamic interactions.

Additionally, this medication should not be used in conjunction with any other products containing acetaminophen, whether prescription or over-the-counter. Co-administration may lead to an increased risk of acetaminophen-related hepatotoxicity. If there is uncertainty regarding the presence of acetaminophen in other medications, patients are advised to seek guidance from a healthcare provider.

Packaging & NDC

Below are the non-prescription pack sizes of Sohmed Extra Strength (acetaminophen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional before use. For adolescents aged 12 years and older, the recommended dosage is 2 caplets every 6 hours as needed for symptom relief, with a maximum of 6 caplets in a 24-hour period. Treatment should not exceed 10 days unless directed by a healthcare provider.

Geriatric Use

Elderly patients should consult a healthcare provider prior to using this medication, particularly if they have liver disease, as this may affect the drug's metabolism and safety profile. Additionally, it is important for geriatric patients to inform their doctor or pharmacist if they are concurrently taking the anticoagulant warfarin, due to potential interactions that could increase the risk of bleeding.

Furthermore, this medication should not be used for more than 10 days unless specifically directed by a healthcare professional. Prolonged use in elderly patients may necessitate careful monitoring for adverse effects and efficacy, given the increased likelihood of comorbidities and polypharmacy in this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is important to evaluate the potential risks and benefits associated with the use of this drug during pregnancy and lactation. Healthcare providers should consider the available data and individual patient circumstances when advising on the use of this medication in these populations.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data regarding the excretion of this medication in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

There is no specific information regarding renal impairment, dosage adjustments, special monitoring, or safety considerations for patients with reduced kidney function provided in the drug insert. Healthcare professionals should exercise caution when prescribing this medication to patients with renal impairment, as the absence of data necessitates careful clinical judgment and monitoring.

Hepatic Impairment

Patients with hepatic impairment should consult a healthcare professional prior to using this product. It is important to note that exceeding the recommended dosage may lead to liver damage. Specifically, severe liver damage can occur if a patient ingests more than 4,000 mg of acetaminophen within a 24-hour period. Additionally, the risk of severe liver damage increases if acetaminophen is taken concurrently with other medications that also contain acetaminophen.

Patients with compromised liver function should be particularly cautious if they consume three or more alcoholic beverages daily while using this product, as this may further elevate the risk of liver damage. Monitoring of liver function may be warranted in these patients to ensure safety and prevent potential adverse effects.

Overdosage

In the event of an overdose, the potential for liver damage increases significantly when the recommended dose is exceeded. It is imperative that healthcare professionals recognize the seriousness of this situation and act promptly.

Immediate medical assistance is crucial. In cases of suspected overdose, individuals should seek medical help or contact a Poison Control Center without delay. The national Poison Control Center can be reached at 1-800-222-1222.

It is important to note that quick medical attention is essential for both adults and children, even in the absence of noticeable signs or symptoms. Early intervention can be critical in mitigating the effects of an overdose and preventing serious complications.

Nonclinical Toxicology

Pregnant or breastfeeding individuals are advised to consult a health professional prior to using this product due to potential teratogenic effects.

While non-teratogenic effects are rare, there have been reports of serious skin reactions associated with the consumption of acetaminophen. These reactions may manifest as rash, blisters, and in severe cases, extensive damage to the skin's surface. Individuals experiencing any skin reactions while using this product should discontinue use immediately and seek medical attention.

No specific information is available regarding nonclinical toxicology or animal pharmacology and toxicology in the provided insert.

Postmarketing Experience

Reports from postmarketing surveillance indicate that, although rare, serious skin reactions have been associated with the consumption of acetaminophen. These reactions may manifest as symptoms including rash, blisters, and, in severe cases, extensive damage to the skin's surface. Patients are advised to discontinue use of the product and seek medical attention if they experience any rash or other skin reactions while taking acetaminophen.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. Patients should be informed not to use this product in conjunction with any other medications that contain acetaminophen, whether prescription or nonprescription. If patients are uncertain whether a medication contains acetaminophen, they should be encouraged to consult with a doctor or pharmacist.

It is crucial to inform patients that they should not use this product if they have a known allergy to acetaminophen or any of the inactive ingredients present in the formulation. Patients should be instructed to discontinue use and seek medical advice if their pain worsens or persists for more than 10 days, or if their fever worsens or lasts longer than 3 days. Additionally, patients should be advised to stop using the medication and consult a doctor if they experience new symptoms, or if they notice any redness or swelling, as these may indicate a serious condition.

Patients with liver disease should be encouraged to consult a doctor before using this medication. Furthermore, those taking the blood-thinning medication warfarin should be advised to speak with a doctor or pharmacist prior to use to ensure safety and avoid potential interactions.

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 temperature range of 20°-25°C (68°-77°F) to maintain its efficacy. For proper inventory management, users should refer to the end flap of the packaging for the expiration date and lot number, ensuring that the product is used within its designated shelf life.

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 as needed, with a maximum of 6 caplets in a 24-hour period, unless otherwise directed by a physician. Use should not exceed 10 days without medical advice. For children under 12 years, consultation with a doctor is advised prior to use.

Clinicians should counsel patients to seek professional advice if they are pregnant or breastfeeding. Additionally, patients with liver disease or those taking the anticoagulant warfarin should consult a healthcare provider before use.

Drug Information (PDF)

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

View product document (PDF)