Pain Relief

Description

Meijer® is a regular strength pain reliever and fever reducer indicated for individuals aged 6 years and over. Each tablet contains 325 mg of acetaminophen as the active ingredient. The product is designed for the relief of pain and reduction of fever, and it is comparable to Tylenol®. The package contains 100 tablets, providing a convenient dosage form for users.

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, minor pain of arthritis, backache, muscular aches, toothache, 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 older are advised to take 2 tablets every 4 to 6 hours as needed while symptoms persist. The maximum dosage should not exceed 10 tablets within a 24-hour period. Continuous use beyond 10 days is not recommended unless directed by a healthcare professional.

For children aged 6 to 11 years, the recommended dosage is 1 tablet every 4 to 6 hours while symptoms last. The total daily intake should not surpass 5 tablets, and use should not extend beyond 5 days unless specifically instructed by a physician.

For children under 6 years of age, it is essential to consult a doctor before administration.

Contraindications

Use of this product is contraindicated in the following situations:

• Co-administration with any other drug containing acetaminophen, whether prescription or nonprescription, 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.

• In individuals with a history of allergic reactions to this product or any of its ingredients, as this may lead to severe hypersensitivity reactions.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen, under the following circumstances: if an adult consumes more than 4,000 mg of acetaminophen within a 24-hour period, if a child takes more than 5 doses in 24 hours, if it is taken concurrently with other medications containing acetaminophen, or if an adult consumes 3 or more alcoholic drinks daily while using this product.

Acetaminophen may also cause severe skin reactions, which can manifest as skin reddening, blisters, or rash. In the event of a skin reaction, it is imperative to discontinue use immediately and seek medical assistance.

Healthcare professionals should advise patients to consult a doctor prior to use if they have liver disease or if a child is experiencing pain due to arthritis. Additionally, it is recommended that patients consult a doctor or pharmacist before using this product if they are concurrently taking the anticoagulant warfarin.

Patients should be instructed to stop taking the product and contact their healthcare provider if any of the following occur: pain worsens or persists for more than 10 days in adults or 5 days in children, fever worsens or lasts for more than 3 days, new symptoms arise, or if redness or swelling is observed. These symptoms may indicate a serious underlying condition that requires further evaluation.

Side Effects

Severe liver damage may occur in patients who exceed the recommended dosage of acetaminophen, specifically if an adult takes more than 4,000 mg within a 24-hour period, or if a child takes more than 5 doses in the same timeframe. The risk of liver damage is further increased when acetaminophen is taken in conjunction with other medications containing acetaminophen or if an adult consumes three or more alcoholic drinks daily while using this product.

Patients should be aware of the potential for severe skin reactions associated with acetaminophen use. Symptoms may include skin reddening, blisters, and rash. In the event of a skin reaction, it is imperative to discontinue use and seek medical assistance immediately.

Acetaminophen should not be used in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription. Patients uncertain about the presence of acetaminophen in their medications are advised to consult a doctor or pharmacist. Additionally, individuals with a history of allergic reactions to acetaminophen or any of its ingredients should refrain from using this product.

Before using acetaminophen, patients should consult a doctor if they have liver disease or if a child is experiencing pain due to arthritis. Furthermore, it is recommended that patients taking the blood-thinning medication warfarin seek advice from a doctor or pharmacist prior to use.

Patients are advised to discontinue use and consult a doctor if pain worsens or persists beyond 10 days for adults or 5 days for children, if fever worsens or lasts more than 3 days, if new symptoms arise, or if redness or swelling is observed. These symptoms 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, it is advised that this medication not be taken 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 toxicity. Monitoring for signs of liver damage is recommended in such cases.

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 aged 6 years and older may use this medication. For children aged 6 to 11 years, the recommended dosage is 1 tablet every 4 to 6 hours as needed for symptom relief, with a maximum of 5 tablets in a 24-hour period. Treatment should not exceed 5 consecutive days unless directed by a healthcare professional.

For children under 6 years of age, it is advised to consult a doctor before use.

Geriatric Use

There is no specific information available 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 individual responses may vary. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is essential to evaluate the potential risks and benefits associated with its use during pregnancy and lactation.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. 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 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 patients 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 consult a healthcare professional prior to use. It is essential for individuals with liver disease to seek medical advice to determine the appropriateness of treatment and any necessary adjustments to dosage or monitoring requirements.

Overdosage

In cases of overdosage, significant health risks are associated with the consumption of acetaminophen.

Adult Overdosage An adult who ingests more than 4,000 mg of acetaminophen within a 24-hour period is at risk of experiencing severe liver damage. It is crucial for healthcare professionals to monitor patients for symptoms of liver impairment, which may include jaundice, abdominal pain, and altered mental status.

Pediatric Overdosage For pediatric patients, the risk of severe liver damage arises if a child takes more than five doses of acetaminophen within a 24-hour timeframe. Healthcare providers should be vigilant in assessing the child's dosage history and any accompanying symptoms indicative of liver distress.

Drug Interactions The concomitant use of acetaminophen with other medications that also contain acetaminophen can exacerbate the risk of severe liver damage. It is essential for healthcare professionals to review all medications a patient is taking to prevent unintentional overdose.

Alcohol Consumption Adults who consume three or more alcoholic drinks daily while using acetaminophen are also at an increased risk for severe liver damage. Clinicians should advise patients on the dangers of combining alcohol with acetaminophen and consider alternative pain management strategies for those with a history of alcohol use.

In the event of suspected overdosage, immediate medical intervention is recommended. Healthcare professionals should initiate appropriate management protocols, which may include supportive care and monitoring of liver function tests.

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 understanding of potential risks associated with the compound in nonclinical settings.

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 to keep this medication out of reach of children to prevent accidental ingestion. It is important to inform patients not to use this product in conjunction with any other medications that contain acetaminophen, whether prescription or nonprescription. If patients are uncertain about the presence of acetaminophen in their other medications, they should be encouraged to consult with a doctor or pharmacist.

Patients should be cautioned against using this product if they have a history of allergic reactions to it or any of its ingredients. They should be instructed to discontinue use and seek medical advice if their pain worsens or persists beyond 10 days for adults or 5 days for children. Additionally, if a fever worsens or lasts more than 3 days, or if new symptoms arise, patients should be advised to stop use and consult a doctor.

Healthcare providers should also inform patients to seek medical attention if they notice any redness or swelling, as these may indicate a serious condition. It is essential to recommend that patients consult a doctor before using this medication if they have liver disease or if they are children experiencing pain due to arthritis. Furthermore, patients taking the blood-thinning medication warfarin should be advised to speak with a doctor or pharmacist prior to using this product.

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, specifically within the range of 20°C to 25°C (68°F to 77°F). It is essential to protect the product from light exposure to ensure its efficacy. Additionally, the product should be kept out of reach of children, and any unused portion should be discarded after opening to prevent potential safety risks.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. Additionally, it is important to keep the medication out of reach of children to ensure safety. No further information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

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.

View product document (PDF)