Pain Reliever

Description

Acetaminophen is a non-aspirin analgesic and antipyretic agent. Each tablet contains 325 mg of acetaminophen, and the product is supplied in a bottle containing 100 tablets.

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 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:

The product should not be used in conjunction with any other medication containing acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in other medications, consultation with a healthcare professional is advised.

Additionally, this product is contraindicated in individuals with a known allergy to acetaminophen or any of the inactive ingredients contained within the formulation.

Warnings and Precautions

This product contains acetaminophen, and it is crucial for healthcare professionals to be aware of the associated risks and recommended precautions to ensure safe usage.

Warnings The maximum daily dose for adults is 10 tablets (3,250 mg) within a 24-hour period, while for children, it is limited to 5 tablets (1,625 mg) in the same timeframe. Severe liver damage may occur under the following circumstances: if an adult consumes more than 4,000 mg of acetaminophen in 24 hours; if a child exceeds 5 doses in 24 hours; if this product is taken concurrently with other medications containing acetaminophen; or if an adult consumes 3 or more alcoholic beverages daily while using this product.

General Precautions Healthcare professionals should advise patients to consult a doctor prior to use if they have a history of liver disease. Additionally, it is recommended that patients taking the anticoagulant warfarin seek guidance from a doctor or pharmacist before using this product.

Emergency Medical Help Instructions In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted at 1-800-222-1222. Prompt medical attention is essential for both adults and children, even if no signs or symptoms are initially apparent.

Stop Taking and Call Your Doctor Instructions Patients should discontinue use and consult a doctor if any of the following occur: pain worsens or persists for more than 10 days in adults; pain worsens or lasts more than 5 days in children under 12 years; fever worsens or lasts more than 3 days; new symptoms develop; or if redness or swelling is observed. 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. The product contains acetaminophen, and exceeding the maximum daily dose of 4,000 mg for adults or 5 doses (1,625 mg) for children may lead to severe liver damage. This risk is heightened if the product is taken in conjunction with other medications containing acetaminophen or if the patient consumes three or more alcoholic drinks daily while using this product.

Patients are advised not to use this product if they are allergic to acetaminophen or any of the inactive ingredients. Additionally, it is important to avoid concurrent use with any other drug containing acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in other medications, consultation with a healthcare professional is recommended.

Before using this product, patients with liver disease should seek medical advice. Furthermore, individuals taking the anticoagulant warfarin should consult a doctor or pharmacist prior to use.

Patients should discontinue use and consult a healthcare provider if they experience worsening pain that lasts more than 10 days in adults or more than 5 days in children under 12 years, if fever worsens or persists for more than 3 days, if new symptoms arise, or if there is any redness or swelling, as these may indicate a serious condition.

In the event of an overdose, it is critical to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222. Prompt medical attention is essential for both adults and children, even if no signs or symptoms are immediately 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. If there is uncertainty regarding the presence of acetaminophen in other medications, it is advisable to seek guidance from a healthcare provider or pharmacist to avoid potential overdose and associated adverse effects.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 6 years of age should consult a doctor before use. For children aged 6 to 11 years, the recommended dosage is 1 tablet every 4 to 6 hours as needed, with a maximum of 5 tablets in a 24-hour period. Use should not exceed 5 days unless directed by a healthcare professional.

In adolescents aged 12 years and older, the dosage is 2 tablets every 4 to 6 hours as needed, with a maximum of 10 tablets in a 24-hour period. Use should not exceed 10 days unless directed by a healthcare professional.

Healthcare providers should be aware of warning signs in pediatric patients, including worsening pain lasting more than 5 days in children under 12 years, fever that worsens or lasts more than 3 days, the occurrence of new symptoms, or the presence of redness or swelling. These symptoms may indicate a serious condition requiring medical attention.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, as the prescribing information does not provide any age considerations, dosage adjustments, safety concerns, or special precautions for this population.

Healthcare providers should exercise clinical judgment when prescribing this medication to geriatric patients, considering the absence of data specific to this demographic. Monitoring for efficacy and safety in elderly patients is advised, given the general considerations associated with pharmacotherapy in this age group.

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 therefore, caution is advised.

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 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. 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 using this product. It is important to note that severe liver damage may occur if an adult exceeds a dosage of 4,000 mg of acetaminophen within a 24-hour period. Additionally, patients who consume three or more alcoholic drinks daily while using this product are at an increased risk for severe liver damage. Therefore, careful consideration and monitoring of liver function are essential for patients with compromised liver function to prevent potential adverse effects.

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 intervention is essential for both adults and children, even in the absence of noticeable 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 medical evaluation are crucial in managing overdose situations effectively.

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

No postmarketing experience details are available in the insert text.

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 whether a medication contains acetaminophen, they should be encouraged to consult with a doctor or pharmacist.

Patients should be made aware that this product should not be used if they have a known allergy to acetaminophen or any of the inactive ingredients present in the formulation. They should be instructed to discontinue use and seek medical advice if their pain worsens or persists for more than 10 days in adults, or for more than 5 days in children under 12 years of age. 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 healthcare professional.

It is crucial to inform patients to seek medical attention if they notice any redness or swelling, as these may indicate a serious condition. Patients with liver disease should be advised to consult a doctor before using this product. Furthermore, those taking the blood-thinning medication warfarin should be encouraged 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 a carton that should be retained for complete product information. It is essential to store the product at a temperature range of 20-25°C (68-77°F) to ensure its stability and efficacy. Proper handling and storage conditions must be adhered to in order to maintain the integrity of the product.

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. No additional information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

Drug Information (PDF)

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

View product document (PDF)