Acetaminophen

Description

No relevant information is available for SPL code 34089-3.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various conditions, including headache, backache, muscular aches, minor pain of arthritis, 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 advised to take 2 tablets every 4 to 6 hours as needed while symptoms persist. 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 without medical supervision.

For children aged 6 to 11 years, the recommended dosage is 1 tablet every 4 to 6 hours while symptoms last. The total daily intake should not surpass 5 tablets, and use should be limited to a maximum of 5 days unless directed by a physician.

For children under 6 years of age, it is recommended to consult a healthcare provider 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 non-prescription, 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 necessitates careful monitoring due to the potential for severe liver damage. The maximum daily dosage for adults is limited to 10 tablets (3,250 mg) within a 24-hour period, while for children, the maximum is 5 tablets (1,625 mg) in the same timeframe. Liver damage may occur if an adult exceeds 4,000 mg of acetaminophen in 24 hours, if a child takes more than the recommended 5 doses, if the product is used concurrently with other medications containing acetaminophen, or if an adult consumes 3 or more alcoholic beverages daily while using this product.

Healthcare professionals should be vigilant for signs of severe skin reactions associated with acetaminophen use. Symptoms may include skin reddening, blisters, or rash. Should any of these symptoms manifest, it is imperative to discontinue use immediately and seek medical assistance.

General precautions advise that individuals with liver disease should consult a healthcare provider prior to use. Additionally, it is recommended that users taking the anticoagulant warfarin or children experiencing pain due to arthritis consult with a doctor or pharmacist before administration.

In the event of an overdose, immediate medical attention is crucial. Users should 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 overt symptoms.

Patients should be instructed to discontinue use and contact their healthcare provider if the following conditions arise: worsening pain in adults lasting more than 10 days, worsening pain in children lasting more than 5 days, fever persisting or worsening beyond 3 days, presence of redness or swelling, or the emergence of any new symptoms.

Side Effects

Severe adverse reactions associated with this product include the potential for severe liver damage, particularly in adults who exceed a daily dose of 4,000 mg of acetaminophen or in children who take more than the maximum daily amount of 5 doses (1,625 mg). The risk of liver damage is further heightened when this product is taken in conjunction with other medications containing acetaminophen or when consumed by adults who regularly consume three or more alcoholic drinks daily.

Patients should be aware of the risk of severe skin reactions, which may manifest as skin reddening, blisters, or rash. In the event of any skin reaction, it is imperative to discontinue use and seek immediate medical assistance.

Participants are advised against using this product in conjunction with any other drug containing acetaminophen, whether prescription or non-prescription. Individuals with known allergies 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, individuals taking the anticoagulant warfarin or children experiencing arthritis-related pain should seek guidance from a doctor or pharmacist before use.

Patients are instructed to discontinue use and consult a healthcare provider if their pain worsens or persists beyond 10 days for adults or 5 days for children, if fever worsens or lasts more than 3 days, if redness or swelling occurs, or if any new symptoms arise.

In cases of overdose, immediate medical attention is crucial. Patients should 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 signs or symptoms.

Drug Interactions

Patients taking warfarin, a blood-thinning medication, should consult with a healthcare professional prior to using this product. The interaction between this product 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 325mg. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 6 to 11 years may take 1 tablet every 4 to 6 hours as needed for symptom relief, with a maximum of 5 tablets (1,625 mg) 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. It is important to note that exceeding 5 doses in a 24-hour period poses a risk of overdose.

Geriatric Use

There is no specific information 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.

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 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 not been specifically addressed in the drug insert regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the absence of detailed 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, which contains acetaminophen. The maximum daily dose for adults is limited to 10 tablets (3,250 mg) within a 24-hour period, while for children, the maximum is 5 tablets (1,625 mg) in the same timeframe. It is critical to note that severe liver damage may occur if the following conditions are met:

• An adult consumes more than 4,000 mg of acetaminophen within 24 hours.

• A child exceeds 5 doses in a 24-hour period, which is the established maximum daily amount.

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

• An adult consumes 3 or more alcoholic drinks daily while using this product.

Patients with liver disease are advised to consult a healthcare professional prior to using this product to assess the appropriateness of treatment and to determine any necessary dosage adjustments or monitoring requirements.

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 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 health consequences. Therefore, vigilance and timely medical evaluation are essential in managing overdose situations effectively.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

Postmarketing experience has identified that acetaminophen may be associated with severe skin reactions. Reports indicate that symptoms can include skin reddening, blisters, and rash. In the event of a skin reaction, it is advised to discontinue use and seek medical assistance immediately.

Patient Counseling

Healthcare providers should advise patients on the importance of seeking immediate medical assistance in the event of an 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 a configuration that includes an imprinted safety seal under the cap. It is essential to ensure that this seal is intact before use, as the product should not be utilized if the seal is broken or missing.

For optimal storage, the product must be kept at room temperature, specifically within the range of 20° to 25°C (68° to 77°F). Proper handling and storage conditions are crucial to maintain the integrity and efficacy of the product.

Additional Clinical Information

Adults and children aged 12 years and over are advised to take 2 tablets every 4 to 6 hours as needed for symptom relief. For children aged 6 to 11 years, the recommended dosage is 1 tablet every 4 to 6 hours while symptoms persist.

Clinicians should counsel patients to consult a health professional if they are pregnant or breastfeeding before use. It is important to keep the medication out of reach of children. In the event of an overdose, patients should seek medical assistance or contact a Poison Control Center immediately at 1-800-222-1222.

Drug Information (PDF)

This file contains official product information for Acetaminophen 325mg, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)