Muscle Pain Relief

Description

This product contains acetaminophen 650 mg as the active ingredient, serving as an extended-release pain reliever and fever reducer. It is formulated in the form of caplets, which are capsule-shaped bi-layer tablets designed to provide relief for up to 8 hours from minor muscle aches and pain. This product is comparable to the active ingredient found in Tylenol® 8 HR Muscle Aches & Pain; however, it is not manufactured or distributed by McNeil Consumer Healthcare, the distributor of Tylenol® 8 HR Muscle Aches & Pain.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various conditions, including muscular aches, backache, minor pain of arthritis, toothache, premenstrual and menstrual cramps, headache, and discomfort related to the common cold. 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 8 hours with water. The caplets should be swallowed whole and must not be crushed, chewed, split, or dissolved. The maximum dosage should not exceed 6 caplets within a 24-hour period. Additionally, the use of this medication should not extend beyond 10 days unless directed by a healthcare professional.

For individuals under 18 years of age, it is recommended to consult a doctor prior to use.

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. If there is uncertainty regarding the presence of acetaminophen in another medication, 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.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen. Healthcare professionals should advise patients that the risk of liver injury increases if they exceed the maximum daily dosage of 6 caplets within a 24-hour period, use other medications containing acetaminophen concurrently, or consume 3 or more alcoholic beverages daily while taking this product.

Acetaminophen may also lead to severe skin reactions, which can manifest as skin reddening, blisters, or rash. In the event of any skin reaction, patients should be instructed to discontinue use immediately and seek medical assistance.

It is essential for patients to consult a healthcare provider prior to using this product if they have a history of liver disease. Additionally, patients taking the anticoagulant warfarin should seek advice from a doctor or pharmacist before use, as potential interactions may occur.

In cases of overdose, immediate medical attention is crucial. Patients should be directed to contact a Poison Control Center (1-800-222-1222) or seek emergency medical help without delay, regardless of the presence of symptoms.

Patients should also be advised to discontinue use and consult a healthcare professional if any of the following occur: worsening pain that persists beyond 10 days, fever that worsens or lasts more than 3 days, the emergence of new symptoms, or the presence of redness or swelling. These signs may indicate a serious underlying condition that requires further evaluation.

Side Effects

Patients using this product should be aware of several important warnings and potential adverse reactions.

Severe liver damage may occur with the use of this product, particularly if patients exceed the maximum daily dosage of 6 caplets within a 24-hour period, use other medications containing acetaminophen concurrently, or consume three or more alcoholic drinks daily while using this product.

Additionally, there is an allergy alert associated with acetaminophen, which may lead to severe skin reactions. Symptoms of such reactions can include skin reddening, blisters, and rash. If any of these symptoms occur, patients are advised to discontinue use immediately and seek medical assistance.

Patients should not use this product in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription. It is also contraindicated for individuals who are allergic to acetaminophen or any of the inactive ingredients present in the formulation.

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

Patients are advised to stop using the product and consult a healthcare provider 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 is observed, as these may indicate a serious condition.

In the event of an overdose, it is critical to seek medical help or contact a Poison Control Center immediately, as prompt medical attention is essential for both adults and children, even if no signs or symptoms are initially apparent.

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. Patients are advised to verify the presence of acetaminophen in other medications by consulting a healthcare provider or pharmacist to avoid unintentional overdose and associated adverse effects.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 18 years of age should consult a doctor before use. For children aged 12 years and older, the recommended dosage is 2 caplets every 8 hours with water, not to exceed 6 caplets in a 24-hour period. The medication should not be used for more than 10 days unless directed by a healthcare professional. In the event of an overdose, prompt medical attention is essential for both adults and children, even if no signs or symptoms are apparent.

Geriatric Use

Elderly patients may not have specific dosage adjustments, safety concerns, or special precautions outlined in the prescribing information. Therefore, healthcare providers should exercise clinical judgment when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any potential adverse effects or changes in therapeutic response, given the variability in pharmacokinetics and pharmacodynamics that can occur with aging.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is important to assess the potential risks and benefits associated with its use during pregnancy and lactation. The safety of this medication in pregnant women has not been established, and caution is advised to ensure the well-being of both the mother and the fetus.

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 drug in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data necessitates careful clinical judgment.

Hepatic Impairment

Patients with hepatic impairment should exercise caution when using this product, as it contains acetaminophen, which is associated with the risk of severe liver damage. It is critical that patients do not exceed the maximum daily dosage of 6 caplets within a 24-hour period. Additionally, patients must avoid concurrent use with other medications containing acetaminophen, as this can further increase the risk of liver injury.

Patients with compromised liver function are advised to consult a healthcare professional prior to using this product, particularly if they have a history of liver disease. Furthermore, consumption of three or more alcoholic drinks per day while using this product is strongly discouraged, as it may exacerbate the risk of liver damage. Regular monitoring of liver function may be warranted in patients with existing liver conditions to ensure safety and efficacy during treatment.

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 medical intervention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Healthcare professionals should be aware that the severity of symptoms may vary depending on the specific substance involved in the overdose. Therefore, a thorough assessment and monitoring of the patient are essential.

Management procedures should include the following steps:

1. Assessment: Evaluate the patient's clinical status, including vital signs and level of consciousness.

2. Supportive Care: Provide supportive care as needed, which may include airway management, oxygen supplementation, and intravenous fluids.

3. Decontamination: If appropriate and within the timeframe, consider decontamination methods such as activated charcoal, following established protocols.

4. Symptomatic Treatment: Administer treatment for specific symptoms as they arise, based on the clinical presentation.

It is critical to maintain a high index of suspicion for potential overdose, as early recognition and intervention can significantly improve patient outcomes.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the assessment of potential risks associated with the compound in these areas.

Postmarketing Experience

Postmarketing experience has identified that acetaminophen may be associated with severe skin reactions. Reports indicate that symptoms can include skin reddening, blisters, and rash. In the event of a skin reaction, it is advised to discontinue use immediately and seek medical assistance.

Patient Counseling

Healthcare providers should advise patients on the importance of seeking immediate medical assistance in the event of an overdose. Patients should be informed to contact a Poison Control Center at 1-800-222-1222 without delay. It is crucial to emphasize that prompt medical attention is necessary for both adults and children, even if they do not exhibit any signs or symptoms of overdose. This proactive approach can significantly impact the outcome in such situations.

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 controlled temperature range of 20-25°C (68-77°F) to maintain its integrity and efficacy. Proper storage conditions should be ensured to prevent exposure to extreme temperatures, which may compromise the product's quality.

Additional Clinical Information

Patients aged 12 years and older are advised to take 2 caplets orally every 8 hours with water, ensuring they swallow the caplets whole without crushing, chewing, splitting, or dissolving them. The maximum dosage should not exceed 6 caplets within a 24-hour period, and use should not extend beyond 10 days unless directed by a healthcare professional.

Clinicians should counsel patients to consult a health professional if they are pregnant or breastfeeding. It is essential to keep the medication out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center (1-800-222-1222) should be contacted, as prompt medical attention is crucial for both adults and children, even if no symptoms are apparent.

Drug Information (PDF)

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

View product document (PDF)