Acetaminophen

Description

HONEYWELL NON-ASPIRIN X STRENGTH ACETAMINOPHEN is formulated as a tablet containing 500 mg of acetaminophen. The product is identified by the National Drug Code (NDC) 022125 and is regulated under the Center for Drug Evaluation and Research (CDER). The formulation is designed to provide effective pain relief without the use of aspirin.

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, toothache, muscular aches, and premenstrual and menstrual cramps. Additionally, it is indicated for the temporary relief 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 instructed to take 2 tablets every 6 hours as needed for symptom relief. 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 specifically 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. If there is uncertainty regarding the presence of acetaminophen in a medication, 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.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen. Healthcare professionals should be aware of the following critical warnings regarding liver safety:

• Adults should not exceed 4000 mg of acetaminophen within a 24-hour period.

• For children, the maximum daily dosage is limited to 5 doses within the same timeframe.

• Caution is advised when this product is taken in conjunction with other medications containing acetaminophen.

• Patients who consume three or more alcoholic beverages daily should be particularly cautious, as this increases the risk of liver damage.

In addition to liver-related warnings, there is an allergy alert associated with acetaminophen. Severe skin reactions may occur, presenting symptoms such as skin reddening, blisters, and rash. Should any skin reaction manifest, it is imperative to discontinue use immediately and seek medical assistance.

General precautions should be observed prior to use. Patients with a history of liver disease should consult a healthcare provider before using this product. Additionally, individuals taking the anticoagulant warfarin should seek advice from a doctor or pharmacist before administration.

In the event of an overdose, immediate medical attention is crucial. Patients or caregivers should contact a Poison Control Center at 1-800-222-1222 without delay. Quick medical intervention is essential for both adults and children, even if no symptoms are initially apparent.

Patients should be advised to discontinue use and consult a healthcare professional if any of the following occur: pain worsens or persists beyond 10 days, fever intensifies or lasts more than 3 days, new symptoms arise, or if redness or swelling is observed. These signs 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, adults should not take more than 4000 mg of acetaminophen within a 24-hour period, and children should not exceed 5 doses in the same timeframe, which constitutes the maximum daily amount. The risk of liver damage is further heightened if acetaminophen is taken in conjunction with other medications containing acetaminophen or if an adult consumes 3 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 indicative of such reactions 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.

Participants in clinical settings should be advised to stop use and consult a healthcare professional if pain worsens or persists beyond 10 days, if fever intensifies or lasts more than 3 days, if new symptoms arise, or if redness or swelling is observed, as these may signal a serious underlying condition.

Patients with liver disease should consult a doctor prior to using this product. Additionally, individuals taking the blood-thinning medication warfarin are advised to seek guidance from a doctor or pharmacist before use.

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 avoid potential 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 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. It is important to note that severe liver damage may occur if a child exceeds 5 doses within a 24-hour period, which is the maximum recommended daily amount. In the event of an overdose, prompt medical attention is essential, even if the child does not exhibit any signs or symptoms.

Healthcare providers should advise caregivers to discontinue use and seek medical advice if the child's pain worsens or persists for more than 10 days, if fever intensifies or lasts longer than 3 days, if new symptoms arise, or if there is any redness or swelling. These symptoms may indicate a serious underlying condition that requires further evaluation.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The safety of this drug during pregnancy has not been established, and potential risks to fetal outcomes are not fully understood. Therefore, it is essential for women of childbearing potential to seek medical advice to weigh the benefits and risks associated with the use of this medication during pregnancy and lactation.

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 mothers.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available data 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 lack of information necessitates careful clinical judgment and monitoring.

Hepatic Impairment

Patients with hepatic impairment should be closely monitored due to the potential for severe liver damage associated with the use of this product, which contains acetaminophen. It is critical to adhere to the following guidelines to minimize the risk of hepatotoxicity.

Adults should not exceed 4000 mg of acetaminophen in a 24-hour period. For pediatric patients, the maximum daily amount is limited to 5 doses within the same timeframe. Additionally, patients must be cautious when using this product in conjunction with other medications that contain acetaminophen, as this can lead to unintentional overdose and subsequent liver damage.

Furthermore, patients with a history of alcohol consumption should be particularly vigilant. The concurrent use of this product with the consumption of 3 or more alcoholic drinks per day significantly increases the risk of severe liver damage.

It is advisable for healthcare providers to assess liver function and consider dosage adjustments or alternative therapies for patients with compromised liver function to ensure safety and efficacy. Regular monitoring of liver enzymes may be warranted in these patients to detect any early signs of hepatic injury.

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 symptoms.

Healthcare professionals should be aware that the severity of symptoms may vary, and early recognition and management are essential to mitigate potential complications. It is recommended that healthcare providers monitor the patient closely and initiate appropriate supportive care as needed.

Nonclinical Toxicology

There is currently no available information regarding teratogenic or non-teratogenic effects associated with the compound. Additionally, no data has been provided concerning nonclinical toxicology, including animal pharmacology and toxicology.

Postmarketing Experience

Acetaminophen has been associated with severe skin reactions reported in postmarketing experience. Symptoms of these reactions may include skin reddening, blisters, and rash. In cases where a skin reaction occurs, 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 and to be aware of the risks associated with overdose. In the event of an overdose, patients should seek medical help or contact a Poison Control Center immediately at 1-800-222-1222. It is important to emphasize that quick medical attention is critical for both adults and children, even if no signs or symptoms are initially present.

Patients should be informed to consult with a doctor or pharmacist before using this medication if they are taking any other drugs that contain acetaminophen, whether prescription or nonprescription. If patients are unsure whether a drug contains acetaminophen, they should be encouraged to ask a healthcare professional for clarification.

Patients with a known allergy to acetaminophen or any of the inactive ingredients in this product should be advised to avoid its use. Additionally, they should be instructed to stop using the medication and consult a doctor if their pain worsens or persists for more than 10 days, if their fever worsens or lasts more than 3 days, if new symptoms occur, or 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 medication. 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 configuration that includes specific packaging details, which are essential for proper handling and storage. It should be stored at a temperature range of 20ºC to 25ºC (68ºF to 77ºF) to maintain its integrity and efficacy.

Healthcare professionals are advised to inspect the packaging prior to use; the product should not be utilized if the printed packet is torn or punctured, as this may compromise the product's safety and effectiveness. Proper adherence to these storage and handling guidelines is crucial for ensuring optimal product performance.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients to consult a doctor prior to use if they have liver disease or are taking the blood-thinning medication warfarin. Additionally, patients who are pregnant or breastfeeding should seek guidance from a health professional before using this medication.

Drug Information (PDF)

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

View product document (PDF)