Henry Schein Acetaminophen

Description

No description information is available for the drug.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with headache, common cold, muscular aches, toothache, minor arthritis pain, and menstrual cramps. Additionally, it is indicated for the 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 every 4 to 6 hours as needed. It is imperative that the total dosage does not exceed 12 tablets within a 24-hour period.

For children under 12 years of age, this medication is contraindicated and should not be administered.

Contraindications

Use of this product is contraindicated in the following situations:

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

Additionally, the product should not be used for pain relief for more than 10 days unless directed by a physician. For fever management, it should not be used for more than 3 days unless specifically instructed by a healthcare provider.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen. Healthcare professionals should advise patients that the risk of liver injury increases significantly if they exceed the maximum daily dosage of 12 tablets within a 24-hour period, combine this product with other medications containing acetaminophen, or consume three or more alcoholic beverages daily while using this product.

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

It is essential for patients to consult a healthcare provider prior to using this product if they have a history of liver disease. Additionally, patients taking the anticoagulant warfarin should seek advice from a doctor or pharmacist before use, as interactions may occur.

In cases of accidental overdose, immediate medical attention is crucial. Patients should be instructed to contact a Poison Control Center or seek emergency medical help without delay, regardless of whether symptoms are present, as prompt intervention is vital for both adults and children.

Patients should also be advised to discontinue use and consult a healthcare professional if symptoms do not improve, if new symptoms arise, if pain or fever persists or worsens, or if there is any redness or swelling.

Side Effects

Severe liver damage may occur in patients taking this product containing acetaminophen if they exceed the maximum daily amount of 12 tablets within a 24-hour period, use it in conjunction with other drugs containing acetaminophen, or consume 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.

Patients are advised to stop using the product and consult a healthcare professional if symptoms do not improve, new symptoms arise, pain or fever persists or worsens, or if redness or swelling is observed.

It is recommended that patients consult a doctor prior to use if they have liver disease. Additionally, patients taking the blood-thinning medication warfarin should seek advice from a healthcare provider or pharmacist before using this product.

In cases of accidental overdose, it is crucial to obtain medical help or contact a Poison Control Center without delay, as prompt medical attention is essential for both adults and children, even if no signs or symptoms are immediately apparent.

Drug Interactions

Patients taking the anticoagulant warfarin should consult a healthcare professional prior to initiating treatment with 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 warfarin may be required based on the clinical judgment of the healthcare provider.

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 not be administered this medication. For adolescents aged 12 years and older, the recommended dosage is 2 tablets every 4 to 6 hours as needed, with a maximum of 12 tablets in a 24-hour period.

In the event of an accidental overdose, it is crucial to seek medical assistance or contact a Poison Control Center immediately. Prompt medical attention is essential for both adults and pediatric patients, even if no signs or symptoms are 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. The potential risks and benefits must be carefully considered in these populations to ensure the safety of both the mother and the fetus or 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 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 absence of 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 is associated with the risk of severe liver damage. It is critical that patients do not exceed the maximum daily dosage of 12 tablets within a 24-hour period. Additionally, patients must avoid concurrent use with other medications containing acetaminophen, as this can further increase the risk of liver injury.

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 to mitigate the risk of 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 accidental overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Prompt medical attention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Overdosage can lead to severe liver damage, particularly if the intake exceeds 12 tablets within a 24-hour period, which is the established maximum daily dosage. Healthcare professionals should be vigilant in monitoring patients for any signs of liver impairment and initiate appropriate management protocols as necessary.

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 understanding of potential risks associated with the compound in nonclinical settings.

Postmarketing Experience

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

Patient Counseling

Healthcare providers should advise patients to consult a health professional if they are pregnant or breastfeeding before using the medication. It is important for patients to understand the potential risks and benefits associated with the use of the medication during these periods.

In the event of an accidental overdose, healthcare providers should instruct patients to seek medical help or contact a Poison Control Center immediately. Emphasize that prompt medical attention is critical for both adults and children, even if no signs or symptoms of overdose are apparent. This information is vital for ensuring patient safety and effective management of any potential overdose situation.

Storage and Handling

The product is supplied in tamper-evident sealed packets to ensure integrity and safety. It is essential to avoid using any packets that are opened or torn.

For optimal storage, the product should be maintained at room temperature, specifically within the range of 59°F to 86°F (15°C to 30°C). Proper adherence to these storage conditions is crucial to preserve the product's efficacy and safety.

Additional Clinical Information

Adults and children aged 12 years and older are advised to take 2 tablets every 4 to 6 hours as needed, with a maximum of 12 tablets in a 24-hour period. For children under 12 years of age, the medication should not be administered.

Clinicians should counsel patients to consult a health professional if they are pregnant or breastfeeding before use. In the event of an accidental overdose, it is crucial to seek medical assistance or contact a Poison Control Center immediately, as prompt attention is essential for both adults and children, regardless of the presence 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.

View product document (PDF)