Acetaminophen

Description

HONEYWELL NON-ASPIRIN ACETAMINOPHEN TABLET is formulated to contain 325 mg of acetaminophen per tablet. This medication is designed for oral administration and is presented in a tablet dosage form. The product is identified by the code 022125 and is regulated under the Center for Drug Evaluation and Research (CDER).

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 advised to take 2 tablets every 4 to 6 hours as needed for symptom relief. The maximum dosage should not exceed 10 tablets within a 24-hour period unless otherwise directed by a healthcare professional. Additionally, this medication should not be used for more than 10 consecutive days unless specifically instructed by a doctor.

For children aged 6 years to under 12 years, the recommended dosage is 1 tablet every 4 to 6 hours while symptoms persist. The total daily intake should not exceed 5 tablets, and the duration of use should not exceed 5 days unless directed by a healthcare provider.

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

Contraindications

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

Additionally, this product should not be used concurrently with any other medication that contains acetaminophen, whether prescribed or over-the-counter. If there is uncertainty regarding the presence of acetaminophen in another medication, consultation with a healthcare professional is advised.

Warnings and Precautions

This product contains acetaminophen, which carries significant warnings regarding liver health. The maximum daily dosage for adults is limited to 10 tablets (3,250 mg) within a 24-hour period, while for children, it is restricted to 5 tablets (1,625 mg) in the same timeframe. Severe liver damage may occur under the following circumstances:

• Adults exceeding 4,000 mg of acetaminophen in a 24-hour period.

• Children taking more than 5 doses within 24 hours, which is the maximum recommended amount.

• Concurrent use with other medications containing acetaminophen.

• Adults consuming three or more alcoholic beverages daily while using this product.

In addition to liver-related warnings, there is an allergy alert associated with acetaminophen. It may lead to severe skin reactions, which can manifest as skin reddening, blisters, or rash. Should any of these symptoms occur, it is imperative to discontinue use immediately and seek medical assistance.

General precautions should be observed prior to use. Individuals with liver disease should consult a healthcare professional before using this product. Additionally, those 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. Users are advised to contact a Poison Control Center (1-800-222-1222) without delay, as prompt intervention is essential for both adults and children, even in the absence of noticeable symptoms.

Patients should also discontinue use and consult a physician if any of the following occur:

• Pain worsens or persists beyond 10 days.

• Fever intensifies or lasts more than 3 days.

• New symptoms develop.

• Redness or swelling is observed.

These signs may indicate a serious underlying condition that requires medical 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 10 tablets (3,250 mg) for adults or 5 tablets (1,625 mg) for children may lead to severe liver damage. This risk is heightened if adults consume more than 4,000 mg of acetaminophen in 24 hours, if children take more than the maximum daily amount, if the product is used in conjunction with other medications containing acetaminophen, or if adults consume three or more alcoholic drinks daily while using this product.

Additionally, patients should be alert to the possibility of severe skin reactions associated with acetaminophen. Symptoms may include skin reddening, blisters, and rash. Should any of these symptoms occur, patients are advised to discontinue use immediately and seek medical assistance.

In the event of an overdose, it is crucial for patients to obtain medical help or contact a Poison Control Center promptly (1-800-222-1222). Quick medical attention is essential for both adults and children, even if symptoms are not immediately apparent.

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 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.

Before using this product, patients with liver disease should consult a doctor. Furthermore, individuals taking the blood-thinning medication warfarin should seek advice from a healthcare provider or pharmacist prior to use.

Drug Interactions

Patients taking the anticoagulant warfarin should consult with a healthcare professional prior to using this medication. 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 Acetaminophen. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 6 years to under 12 years may take 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, consultation with a doctor is advised prior to use. The maximum daily dose for pediatric patients is limited to 5 doses within a 24-hour timeframe.

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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in 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 on the excretion of this drug in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

There is no information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution and consider the lack of specific guidance when prescribing to patients with reduced kidney function.

Hepatic Impairment

Patients with hepatic impairment should be closely monitored when using this product, which contains acetaminophen. Due to the potential for severe liver damage, it is critical to adhere to the following guidelines regarding dosage and administration.

The maximum daily dose for adults is limited to 10 tablets (3,250 mg) within a 24-hour period. For children, the maximum daily dose is restricted to 5 tablets (1,625 mg) in 24 hours. It is essential to note that severe liver damage may occur if the following conditions are met:

• Adults exceed a total of 4,000 mg of acetaminophen in a 24-hour period.

• Children take more than 5 doses in a 24-hour period, which is the established maximum daily amount.

• The product is taken concurrently with other medications containing acetaminophen.

• Adults consume 3 or more alcoholic drinks daily while using this product.

Given these considerations, healthcare providers should exercise caution and consider alternative therapies for patients with compromised liver function. Regular monitoring of liver function tests may be warranted to ensure patient safety and to mitigate the risk of hepatotoxicity.

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 remain vigilant and prepared to assess the patient's condition thoroughly, as timely treatment can significantly influence outcomes.

In summary, any suspected overdose warrants urgent medical evaluation, and healthcare professionals should ensure that patients and caregivers are informed about the importance of rapid response in such situations.

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

Acetaminophen has been associated with severe skin reactions reported in postmarketing experience. Symptoms of these reactions may 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 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 apparent.

Patients should be informed to consult with a healthcare professional if they are unsure whether any other medications they are taking contain acetaminophen, whether prescription or nonprescription. They should also be cautioned against using this product if they have a known allergy to acetaminophen or any of the inactive ingredients.

Patients 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 develop, or if they notice any redness or swelling, as these may indicate a serious condition.

Additionally, patients should be advised to seek medical advice before using this medication if they have liver disease. It is also important for patients to consult 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 various package configurations, with specific NDC numbers available upon request. It is essential to store the product at a controlled temperature range of 20ºC to 25ºC (68ºF to 77ºF) to maintain its efficacy and stability. Proper container requirements should be adhered to, ensuring that the product is kept in its original packaging to prevent exposure to environmental factors. Special handling needs should be observed to avoid any conditions that may compromise the integrity of the product.

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

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)