Pain Relief

Description

Acetaminophen Coated Tablets are formulated as a pain reliever and fever reducer, each tablet containing 500 mg of acetaminophen. The tablets are sweet coated, designed for adult use. The product is supplied in a bottle containing 100 tablets, with each tablet delivering the specified dosage of 500 mg.

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 tablets every 6 hours as needed while symptoms persist. The tablets should be swallowed whole and must not be crushed, chewed, or dissolved. The maximum dosage should not exceed 6 tablets within a 24-hour period unless otherwise directed by a healthcare professional. Additionally, the use of this medication should not extend beyond 10 days unless 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.

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

Warnings and Precautions

This product contains acetaminophen, which poses a risk of severe liver damage if the following conditions are met: exceeding 4,000 mg of acetaminophen within a 24-hour period, concomitant use with other medications containing acetaminophen, or consumption of three or more alcoholic beverages daily while using this product.

Acetaminophen is also associated with the potential for severe skin reactions. Symptoms indicative of such reactions may include skin reddening, blisters, and rash. Should any of these symptoms occur, it is imperative to discontinue use immediately and seek medical assistance.

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

In the event of an overdose, it is crucial to obtain emergency medical help or contact a Poison Control Center immediately at 1-800-222-1222. Prompt medical attention is essential for both adults and children, even in the absence of noticeable signs or symptoms.

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

Side Effects

Severe liver damage may occur in patients who exceed 4,000 mg of acetaminophen within a 24-hour period, use it in conjunction with other medications containing acetaminophen, or consume three or more alcoholic drinks daily while using this product.

Patients should be aware that acetaminophen may 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 and seek medical assistance immediately.

This product should not be used in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription. Patients who are unsure if a drug contains acetaminophen are advised to consult a doctor or pharmacist. Additionally, individuals with a known allergy to acetaminophen or any of the inactive ingredients in this product should refrain from 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 is observed, as these may indicate a serious condition.

It is recommended that patients with liver disease consult a doctor prior to use. Furthermore, individuals taking the blood-thinning medication warfarin should seek advice from a doctor or pharmacist before using this product.

Drug Interactions

Patients taking warfarin, a blood-thinning medication, should consult with a healthcare professional prior to using this drug. The interaction between this drug and warfarin may necessitate careful monitoring of coagulation parameters to ensure therapeutic efficacy and minimize the risk of adverse effects. Adjustments to the dosage of either medication may be required based on clinical judgment and patient response.

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

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 individual responses may vary. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy, given the lack of targeted clinical data in this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure the safety of both the mother 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 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 exercise caution when using this product, as it contains acetaminophen, which can lead to severe liver damage under certain conditions. Specifically, patients should not exceed 4,000 mg of acetaminophen within a 24-hour period, nor should they use this product in conjunction with other medications that contain acetaminophen. Additionally, consumption of three or more alcoholic drinks daily while using this product may further increase the risk of liver damage.

It is recommended that patients with liver disease consult a healthcare professional prior to using this product to assess the appropriateness of treatment and to discuss potential risks associated with acetaminophen use. Monitoring of liver function may be warranted in these patients to ensure safety and efficacy.

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 health consequences. Therefore, vigilance and timely action 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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

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 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 known allergy to acetaminophen or any of the inactive ingredients included 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, or if their fever intensifies or lasts longer than 3 days. Additionally, patients should be advised to stop using the medication and consult a healthcare professional if they experience new symptoms, or if they notice any redness or swelling, as these may indicate a serious condition.

Healthcare providers should also recommend that patients with liver disease consult a doctor before using this medication. Furthermore, patients taking the blood-thinning medication warfarin should be advised to speak with a doctor or pharmacist prior to using this product 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. There are no additional details available regarding laboratory tests, abuse information, patient counseling, or postmarketing experience.

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)