Acetaminophen

Description

This product is identified by SPL Code 34089-3 and is classified as a maximum strength pain reliever. It is formulated without aspirin and is designed to provide temporary relief from minor aches and pains. The product is packaged in a total of 250 tablets, with 2 tablets per packet. It is marketed under The Provision First Aid Line™ and is produced by Wildman.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with headache, toothache, muscular aches, common cold, minor arthritis pain, and menstrual cramps. Additionally, it is indicated for the reduction of fever.

There are no teratogenic or nonteratogenic effects mentioned in the available data.

Dosage and Administration

Adults and children aged 12 years and over are instructed to take 2 tablets every 6 hours while symptoms persist, or as directed by a healthcare professional. The maximum dosage should not exceed 6 tablets within a 24-hour period unless otherwise directed by a physician. Additionally, this medication should not be used for more than 10 consecutive days unless advised by a healthcare provider.

For children under 12 years of age, it is recommended to consult a doctor for appropriate dosing and administration 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.

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

Warnings and Precautions

This product contains acetaminophen, which poses a significant risk of severe liver damage if not used according to the specified guidelines. Healthcare professionals should advise patients to avoid exceeding 4,000 mg of acetaminophen within a 24-hour period. Additionally, patients should not use this product in conjunction with other medications containing acetaminophen, nor should they consume three or more alcoholic drinks daily while using this product.

Allergy Alert Acetaminophen may induce skin reactions, which can manifest as skin reddening, blisters, or rash. In the event of a skin reaction, patients must discontinue use immediately and seek medical assistance.

Contraindications This product should not be used in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription. Patients uncertain about the acetaminophen content of their medications should consult a healthcare provider. Furthermore, individuals with a known allergy to acetaminophen or any inactive ingredients in this formulation should refrain from using this product.

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

Monitoring and Discontinuation Patients are advised to stop using this product and consult a healthcare provider if any of the following occur: pain worsens or persists beyond 10 days, fever intensifies or lasts more than 3 days, new symptoms develop, or if redness or swelling is observed. These symptoms may indicate a serious underlying condition.

In the event of an accidental overdose, immediate medical attention is essential. Patients should contact a Poison Control Center at 1-800-222-1222 without delay, as prompt intervention is critical for both adults and children, even in the absence of noticeable signs or symptoms.

Side Effects

Severe liver damage may occur in patients taking this product containing acetaminophen if they exceed 4,000 mg in 24 hours, 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 allergic reactions, which may manifest as skin reactions including skin reddening, blisters, and 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 with liver disease should consult a doctor prior to using this product. Furthermore, those taking the blood-thinning medication warfarin should seek advice from a doctor or pharmacist before 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 occurs, as these may indicate a serious condition.

Drug Interactions

Co-administration of this medication with any other drug containing acetaminophen, whether prescription or nonprescription, is contraindicated due to the risk of acetaminophen overdose, which can lead to severe liver damage.

Additionally, caution is advised when using this medication in conjunction with warfarin, a blood-thinning agent. Patients should consult a healthcare professional, such as a doctor or pharmacist, prior to use if they are currently taking warfarin, as this combination may increase the risk of bleeding. Monitoring of coagulation parameters may be warranted in such cases to ensure patient safety.

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. For adolescents aged 12 years and older, the recommended dosage is 2 tablets every 6 hours while symptoms persist, not to exceed 6 tablets in a 24-hour period unless directed by a physician. The medication should not be used for more than 10 days without medical advice.

In the event of an accidental overdose, it is crucial to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222. Prompt medical attention is essential for both adults and children, even if no signs or symptoms are apparent.

Geriatric Use

Elderly patients should consult a healthcare provider prior to use if they have liver disease. For adults and children aged 12 years and older, the recommended dosage is 2 tablets every 6 hours while symptoms persist, with a maximum of 6 tablets in a 24-hour period, unless otherwise directed by a physician. It is important for geriatric patients to avoid using this medication for more than 10 days unless specifically instructed by a healthcare professional.

In the event of an accidental overdose, it is crucial for elderly patients to seek immediate medical assistance or contact a Poison Control Center. Prompt medical attention is essential for all patients, including the elderly, even if no signs or symptoms of overdose are apparent. Careful monitoring and adherence to dosing guidelines are advised to ensure safety in this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is important to assess the potential risks and benefits associated with its use during pregnancy and lactation. The safety of this medication in pregnant women has not been established, and caution is advised to ensure the well-being of both the mother and the fetus.

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

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 lack of data 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 for patients to adhere to the following guidelines to minimize the risk of hepatotoxicity:

• Patients should not exceed a maximum dosage of 4,000 mg of acetaminophen within a 24-hour period.

• Concurrent use with other medications containing acetaminophen is contraindicated, as this may lead to unintentional overdose and increased risk of liver damage.

• Consumption of three or more alcoholic drinks per day while using this product is not recommended, as it may exacerbate the risk of liver injury.

Additionally, patients with a history of liver disease are advised to consult a healthcare professional prior to using this product to ensure safe and appropriate use. Regular monitoring of liver function may be warranted in patients with compromised liver function to detect any potential adverse effects promptly.

Overdosage

In the event of an accidental overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222. Prompt intervention is crucial 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 adverse effects. Therefore, it is essential to monitor the patient closely and provide appropriate medical care as needed.

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 on the importance of seeking immediate medical assistance in the event of an accidental overdose. Patients should be informed to contact a Poison Control Center at 1-800-222-1222 without delay. It is crucial to emphasize that prompt medical attention is necessary for both adults and children, even if they do not exhibit any signs or symptoms of overdose. This proactive approach can significantly impact the outcome in such situations.

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 59ºF to 86ºF (15ºC to 30ºC). Care should be taken to avoid using any packets that are opened or torn, as this may compromise the product's quality and efficacy.

Additional Clinical Information

No further data are available.

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)