Acetaminophen

Description

34089-3 is identified by the SPL code and is associated with the product labeled as 340R-CVS, which is available in a dosage form of 100 count. The product is packaged with a corresponding label indicating its specifications and usage.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various conditions, including headache, muscular aches, backache, 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 instructed 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 without medical advice.

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 must not exceed 5 tablets, and use should be limited to a maximum of 5 days unless directed by a physician.

In the case of children under 6 years of age, it is advised to consult a doctor for appropriate dosing recommendations.

Contraindications

Use of this product is contraindicated in the following situations:

Patients should not use this product in conjunction with any other medication containing acetaminophen, whether prescription or nonprescription, 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.

Additionally, this product is contraindicated 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 carries significant risks for 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. Severe liver damage may occur under the following circumstances:

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

• A child exceeds 5 doses in 24 hours, which is the maximum daily allowance.

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

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

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

General precautions should be observed prior to use. Patients with a history of liver disease should consult a physician before using this product. Additionally, individuals taking the anticoagulant warfarin should seek advice from a healthcare provider or pharmacist before use.

In the event of an overdose, immediate medical attention is crucial. Patients or caregivers should contact a Poison Control Center at 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 be advised to discontinue use and consult a physician if any of the following occur:

• Pain worsens or persists beyond 10 days in adults.

• Pain worsens or lasts more than 5 days in children under 12 years.

• Fever worsens or lasts more than 3 days.

• New symptoms arise.

• Redness or swelling is observed.

These signs may indicate a serious underlying condition that requires further evaluation.

Side Effects

Patients using this product should be aware of the potential for serious adverse reactions, particularly related to liver health and allergic skin responses.

Severe liver damage may occur if adults exceed a maximum daily dose of 4,000 mg of acetaminophen or if children take more than the recommended maximum of 5 doses (1,625 mg) in 24 hours. The risk of liver damage is further increased if the product is taken in conjunction with other medications containing acetaminophen or if the adult consumes three or more alcoholic drinks daily while using this product.

In addition to liver-related warnings, patients should be alert for severe skin reactions associated with acetaminophen. Symptoms of such reactions may include skin reddening, blisters, and rash. If any of these symptoms occur, patients are advised to discontinue use immediately and seek medical assistance.

Patients with pre-existing liver disease should consult a healthcare professional before using this product. Furthermore, individuals taking the anticoagulant warfarin should also seek advice from a doctor or pharmacist prior to use.

Patients are advised to stop using the product and consult a healthcare provider if any of the following occur: pain worsens or persists beyond 10 days in adults or 5 days in children under 12 years, fever worsens or lasts more than 3 days, new symptoms arise, or if redness or swelling is observed. These symptoms may indicate a serious underlying condition that requires medical evaluation.

Drug Interactions

Patients taking warfarin, a blood-thinning medication, should consult with a healthcare professional prior to using this drug. The interaction between this medication 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. 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 (1,625 mg) in a 24-hour period. It is advised that this medication not be used for more than 5 consecutive days unless directed by a healthcare professional.

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

Geriatric Use

Elderly patients should consult a healthcare provider prior to use if they have liver disease, as this may affect the safety and efficacy of the medication. Additionally, it is important for geriatric patients to seek advice from a doctor or pharmacist if they are concurrently taking the anticoagulant warfarin, due to potential interactions that could increase the risk of bleeding.

For elderly patients, it is crucial to adhere to the recommended dosage guidelines. The maximum dosage should not exceed 10 tablets within a 24-hour period unless specifically directed by a healthcare professional. Furthermore, the use of this medication should not extend beyond 10 days unless advised by a doctor, to mitigate the risk of adverse effects and ensure appropriate monitoring of the patient's condition.

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, 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 24 hours, 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 known liver disease are advised to consult a healthcare professional prior to using this product to assess the potential risks and determine appropriate usage. Regular monitoring of liver function may be warranted in these patients to prevent adverse effects.

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 severity of symptoms may vary depending on the specific substance involved in the overdose. Therefore, a thorough assessment and monitoring of the patient are essential.

Management of an overdose may include supportive care and symptomatic treatment, tailored to the individual’s clinical presentation. Continuous evaluation and appropriate interventions should be initiated as necessary to mitigate potential complications associated with the overdose.

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 compound in these areas.

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 immediately and seek medical assistance.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. Patients should be informed not to use this product in conjunction with any other medications that contain acetaminophen, whether prescription or nonprescription. If patients are uncertain whether a medication contains acetaminophen, they should be encouraged to consult with a doctor or pharmacist.

It is crucial to inform patients not to use this product if they have a known allergy to acetaminophen or any of the inactive ingredients present in the formulation. Patients should be instructed to discontinue use and seek medical advice if their pain worsens or persists for more than 10 days in adults, or for more than 5 days in children under 12 years of age. Additionally, if a patient experiences a fever that worsens or lasts more than 3 days, they should stop using the medication and consult a doctor.

Patients should also be made aware that the emergence of new symptoms, or the presence of redness or swelling, warrants immediate medical consultation, as these may indicate a serious condition. It is important to advise patients to seek medical advice before using this product if they have liver disease. Furthermore, patients taking the blood-thinning medication warfarin should be encouraged to consult with a doctor or pharmacist prior to using this product.

Storage and Handling

The product is supplied in packaging that includes specific NDC numbers. It should be stored at a controlled room temperature of 25°C (77°F), with permissible excursions between 15°C and 30°C (59°F to 86°F). It is essential to adhere to the expiration date indicated on the package to ensure product efficacy and safety.

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)