Henry Schein Acetaminophen

Description

Acetaminophen is presented in a dosage form of 500 mg.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various conditions, including headache, muscular aches, minor pain of arthritis, backache, the common cold, 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 instructed to take 2 tablets orally every 4 to 6 hours as needed while symptoms persist. It is imperative not to exceed 6 tablets within a 24-hour period unless specifically 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.

Healthcare professionals should emphasize the importance of adhering to the prescribed dosage and administration guidelines to avoid potential overdose.

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 another medication, consultation with a healthcare professional is advised.

• This product should not be used in individuals with a known allergy to acetaminophen or any of the inactive ingredients contained in the formulation.

Warnings and Precautions

This product contains acetaminophen, which carries significant risks for liver damage. Healthcare professionals should advise patients that severe liver injury may occur if they exceed 4,000 mg in a 24-hour period, which is the maximum recommended daily dosage. Additionally, the risk of liver damage increases if acetaminophen is taken concurrently with other medications containing acetaminophen or if the patient consumes three or more alcoholic beverages daily while using this product.

Patients should also be made aware of the potential for severe skin reactions associated with acetaminophen. Symptoms of such reactions may include skin reddening, blisters, and rash. In the event of a skin reaction, patients must discontinue use immediately and seek medical assistance.

General precautions should be taken into account. Patients with a history of liver disease should consult a healthcare provider prior to using this product. Furthermore, individuals taking the anticoagulant warfarin should seek advice from a doctor or pharmacist before use, as interactions may occur.

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

Patients should be instructed to stop taking the product and consult a healthcare professional if any of the following occur: pain worsens or persists for more than 10 days, fever intensifies or lasts longer than 3 days, new symptoms develop, or if redness or swelling is observed. These signs may indicate a serious underlying condition that requires medical evaluation.

Side Effects

Severe liver damage may occur in patients who exceed the maximum daily dosage of 4,000 mg within a 24-hour period, particularly when combined with other medications containing acetaminophen or when consuming three or more alcoholic drinks daily while using this product.

Patients should be aware of the potential for severe skin reactions associated with acetaminophen, which may 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.

It is contraindicated to use this product in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription. Patients who are allergic to acetaminophen or any inactive ingredients in this product should also refrain from use.

Prior to using this product, patients with liver disease should consult a healthcare professional. Additionally, those taking the anticoagulant warfarin should seek advice from a doctor or pharmacist before use.

Patients are advised to stop using the product and consult a healthcare provider if pain worsens or persists for more than 10 days, if fever intensifies or lasts longer than 3 days, if new symptoms arise, or if redness or swelling occurs, as these may indicate a serious condition.

In the case of an overdose, it is crucial to seek 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 if no signs or symptoms are apparent.

Drug Interactions

Acetaminophen has been shown to enhance the anticoagulant effects of warfarin, which may result in an elevated risk of bleeding. It is recommended that the International Normalized Ratio (INR) be monitored closely in patients who are receiving both acetaminophen and warfarin concurrently to ensure safe therapeutic levels and to mitigate the risk of adverse effects.

No additional drug interactions or interactions with laboratory tests have been identified.

Packaging & NDC

Below are the non-prescription pack sizes of Henry Schein Acetaminophen (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 patients aged 12 years and older, the recommended dosage is 2 tablets every 4 to 6 hours as needed, with a maximum of 6 tablets in a 24-hour period unless otherwise directed by a physician. Treatment should not exceed 10 days without medical advice.

In cases of overdose, prompt medical attention is essential for both adults and pediatric patients, even if no signs or symptoms are immediately apparent.

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, 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. It is important to evaluate the potential risks and benefits associated with the use of this drug during pregnancy and lactation. Healthcare providers should consider the available data and individual patient circumstances when advising on the use of this medication in these populations.

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 drug insert regarding dosage adjustments, special monitoring, or safety considerations. As such, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, given the absence of detailed guidance on its use in this population. Regular monitoring of renal function may be prudent in these patients, although specific recommendations are not provided.

Hepatic Impairment

Patients with hepatic impairment should exercise caution when using this product, as it contains acetaminophen, which is associated with the risk of severe liver damage. It is critical that patients do not exceed the maximum daily dosage of 4,000 mg, as taking more than this amount within a 24-hour period significantly increases the risk of liver injury. Additionally, patients should avoid concurrent use of other medications containing acetaminophen, as this can further elevate the risk of hepatotoxicity.

Patients with compromised liver function are advised to consult a healthcare professional prior to using this product, particularly if they have a history of liver disease. Furthermore, it is recommended that patients limit alcohol consumption to fewer than three alcoholic drinks per day while using this product, as alcohol can exacerbate the potential for liver damage. Regular monitoring of liver function may be warranted in patients with existing liver conditions to ensure safety and efficacy during treatment.

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 signs or symptoms.

Healthcare professionals should be aware that the presentation of symptoms may vary, and vigilance is necessary to ensure appropriate management. The potential for serious complications underscores the importance of rapid response in overdose situations.

Management procedures should include a thorough assessment of the patient's condition, monitoring vital signs, and providing supportive care as needed. It is essential to follow established protocols for overdose management, which may involve decontamination, administration of antidotes if applicable, and symptomatic treatment.

In summary, the key to effective management of an overdose lies in swift action and comprehensive care, ensuring the safety and well-being of the affected individual.

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 these contexts.

Postmarketing Experience

Postmarketing experience has identified severe skin reactions associated with acetaminophen use. Reported symptoms include skin reddening, blisters, and rash. These events have been documented through voluntary reports and surveillance programs.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. In the event of an overdose, it is crucial to seek medical help immediately or contact a Poison Control Center at 1-800-222-1222, as prompt medical attention is essential for both adults and children, even if no signs or symptoms are apparent.

Patients should be informed not to use this medication in conjunction with any other drug that contains acetaminophen, whether prescription or nonprescription. If patients are uncertain about the presence of acetaminophen in any other medications they are taking, they should be encouraged to consult with a doctor or pharmacist.

It is important to instruct patients to discontinue use and consult a doctor if their pain worsens or persists for more than 10 days, if their fever worsens or lasts longer than 3 days, if they experience new symptoms, or if they notice any redness or swelling, as these may indicate a serious condition.

Patients with a history of liver disease should be advised to consult a doctor before using this medication. Additionally, 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 tamper-evident sealed packets to ensure integrity and safety. It is essential to store the packets at room temperature, specifically within the range of 59º-86ºF (15º-30ºC). Healthcare professionals should ensure that any opened or torn packets are not used, as this may compromise the product's quality and efficacy.

Additional Clinical Information

Adults and children aged 12 years and older are advised to take 2 tablets every 4 to 6 hours as needed for symptom relief, with a maximum of 6 tablets in a 24-hour period unless otherwise directed by a healthcare professional. The use of this medication should not exceed 10 days without medical guidance. For children under 12 years, consultation with a doctor is recommended prior to use.

Clinicians should counsel patients to seek advice from a health professional if they are pregnant or breastfeeding. It is important to keep the medication out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center contacted at 1-800-222-1222, as prompt attention is crucial for both adults and children, even in the absence of symptoms.

Drug Information (PDF)

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

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