Pain Relief

Description

Acetaminophen is formulated as a liquid dosage form containing 500 mg of acetaminophen per 15 mL. It serves as a pain reliever and fever reducer, indicated for individuals aged 12 years and older. The product is alcohol-free and features a cherry flavor. It is packaged with a tamper-evident safety seal; users are advised not to use the product if the printed safety seal around the dosage cup or under the cap is broken or missing. This product is distributed by Wal-Mart Inc., located in Bentonville, AR 72716.

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 due to arthritis, toothache, muscular aches, and premenstrual or 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 older are advised to take 30 mL every 6 hours as needed while symptoms persist. It is imperative not to exceed 4 doses within a 24-hour period and to limit the duration of use to a maximum of 10 days unless otherwise directed by a healthcare professional.

For accurate dosing, the provided dosing cup must be used; no other dosing devices should be employed. The dosing cup should be kept with the product to ensure proper measurement.

Children under 12 years of age should not use this product. It is essential to adhere strictly to these guidelines to avoid the risk of overdose.

Contraindications

Use of this product is contraindicated in patients who are concurrently taking any other medication that contains acetaminophen, whether prescription or nonprescription. The combination may lead to an increased risk of acetaminophen-related hepatotoxicity. If there is uncertainty regarding the presence of acetaminophen in other medications, consultation with a healthcare professional is advised.

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 significantly if they exceed 4,000 mg of acetaminophen within a 24-hour period, use other medications containing acetaminophen concurrently, or consume three 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 must 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 there may be potential interactions.

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

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

Side Effects

Patients using this product should be aware of the potential for serious adverse reactions, particularly related to liver health and allergic responses.

Severe liver damage may occur if patients exceed 4,000 mg of acetaminophen within a 24-hour period, use other medications containing acetaminophen concurrently, or consume three or more alcoholic drinks daily while using this product. In the event of an overdose, which is defined as taking more than the recommended dose, patients may experience liver damage. Immediate medical attention is crucial, and patients are advised to contact a Poison Control Center (1-800-222-1222) without delay, even if no symptoms are apparent.

Additionally, acetaminophen may cause severe skin reactions, which can manifest as skin reddening, blisters, or rash. Should any of these symptoms occur, patients must discontinue use and seek medical assistance promptly.

Patients are also advised to stop using the product and consult a healthcare professional if pain worsens or persists for more than 10 days, if fever intensifies or lasts longer than 3 days, if new symptoms arise, or if redness or swelling is observed, as these may indicate a serious underlying condition.

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 Pain Relief (acetaminophen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should not use this medication. For adolescents aged 12 years and older, the recommended dosage is 30 mL every 6 hours while symptoms persist, with a maximum duration of use not exceeding 10 days unless directed by a healthcare professional.

In the event of an overdose, it is crucial to seek immediate medical attention for both adults and pediatric patients, even if no signs or symptoms are apparent.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as they may have altered pharmacokinetics and pharmacodynamics. Close monitoring is recommended to ensure safety and efficacy 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 assess the potential risks and benefits, as well as any available data regarding fetal outcomes and lactation. Healthcare providers can offer guidance tailored to individual circumstances, ensuring the safety of both the patient and the developing fetus or nursing infant.

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

Patients with renal impairment have not been specifically addressed in the drug insert regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment should be advised of the potential risks associated with the use of this product, which contains acetaminophen. Severe liver damage may occur if patients exceed a dosage of 4,000 mg of acetaminophen within a 24-hour period, use other medications containing acetaminophen concurrently, or consume three or more alcoholic drinks daily while using this product.

It is recommended that patients with liver disease consult a healthcare professional prior to using this product. In cases of overdose, which may result from exceeding the recommended dosage, patients should seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222. Prompt medical attention is crucial for both adults and children, even in the absence of noticeable signs or symptoms of overdose.

Monitoring of liver function may be warranted in patients with compromised liver function to mitigate the risk of severe adverse effects.

Overdosage

Taking more than the recommended dose of this medication may lead to serious liver damage. 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.

Recommended Actions

Prompt medical attention is crucial for both adults and children, even if no signs or symptoms of overdose are apparent. Healthcare professionals should be vigilant in assessing the situation and providing appropriate interventions.

Potential Symptoms

While specific symptoms of overdose are not detailed, the risk of liver damage underscores the importance of monitoring for any signs of hepatic impairment following an overdose.

Management Procedures

Upon recognition of an overdose, healthcare providers should initiate standard emergency protocols, which may include supportive care and monitoring of liver function. Early intervention can significantly impact 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 use of the compound in question.

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 about the potential risks associated with overdose, emphasizing that taking more than the recommended dose may lead to liver damage. In the event of an overdose, patients should 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 must be cautioned against using this medication in conjunction with any other products containing acetaminophen, whether prescription or nonprescription. If patients are uncertain whether a drug contains acetaminophen, they should be encouraged to consult with a doctor or pharmacist for clarification.

Healthcare providers should instruct patients to discontinue use and consult a doctor if their pain worsens or persists for more than 10 days. Similarly, patients should be advised to stop use and seek medical advice if their fever worsens or lasts longer than 3 days, if new symptoms arise, or if they notice any redness or swelling, as these may indicate a serious condition.

Additionally, patients should be encouraged to consult a doctor before using this medication if they have a history of liver disease. It is also important to remind patients to speak with a doctor or pharmacist before use if they are currently taking the blood-thinning medication warfarin.

Storage and Handling

The product is supplied in packaging that adheres to the National Drug Code (NDC) specifications. It should be stored at a temperature range of 20-25ºC (68-77ºF) and must not be refrigerated. Additionally, it is essential to protect the product from light to maintain its integrity and efficacy. Proper handling and storage conditions are crucial to ensure the product's quality throughout its shelf life.

Additional Clinical Information

The medication is administered orally, with a recommended dosage of 30 mL every 6 hours for adults and children aged 12 years and older, not to exceed 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, patients should seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222, as prompt medical attention is crucial for both adults and children, even in the absence of symptoms.

Drug Information (PDF)

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

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