Acetaminophen 325 mg

Description

This product is identified by NDC 69618-010-01 and is classified as a Regular Strength formulation. Each tablet contains 325 mg of Acetaminophen USP, which serves as a pain reliever and fever reducer. The product is packaged in a bottle containing 100 tablets. It is formulated to provide relief comparable to the active ingredient found in Regular Strength TYLENOL®.

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 or 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 over are instructed to take 2 tablets every 4 to 6 hours as needed for symptom relief, with a maximum dosage of 12 tablets within a 24-hour period.

For children aged 6 to 11 years, the recommended dosage is 1 tablet every 4 to 6 hours while symptoms persist, not exceeding 5 tablets in a 24-hour timeframe.

The use of this medication is not recommended for children under 6 years of age.

Contraindications

Use of this product is contraindicated in patients who are concurrently taking any other medication that contains acetaminophen, whether prescription or nonprescription. This is due to the potential risk of acetaminophen overdose, which can lead to severe liver damage. If there is uncertainty regarding the presence of acetaminophen in other medications, consultation with a healthcare professional is advised.

Warnings and Precautions

This product contains acetaminophen, which poses significant risks for liver damage under certain conditions. Healthcare professionals should be aware of the following critical warnings and precautions to ensure safe use.

Liver Warning Severe liver damage may occur if an adult exceeds 4,000 mg of acetaminophen in a 24-hour period, which is the maximum daily dosage. For children, the maximum daily amount is limited to 5 tablets. The risk of liver damage is heightened if this product is taken concurrently with other medications containing acetaminophen or if an adult consumes three or more alcoholic drinks while using this product.

Overdose Warning Taking more than the recommended dose can lead to overdose and potential liver damage. In the event of an overdose, it is imperative to seek medical assistance or contact a Poison Control Center immediately. Prompt medical attention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

General Precautions Healthcare providers should advise patients not to use this product in conjunction with any other medications containing acetaminophen, whether prescription or over-the-counter. If there is uncertainty regarding the presence of acetaminophen in other medications, consultation with a doctor or pharmacist is recommended. Additionally, patients with liver disease should consult a healthcare professional before use. Caution is also advised for individuals taking the anticoagulant warfarin; they should seek guidance from a doctor or pharmacist prior to using this product.

Stop Taking and Call Your Doctor Patients should be instructed to discontinue use and consult a healthcare provider if any of the following occur: pain worsens or persists for more than 10 days in adults, pain lasts more than 5 days in children, fever worsens or lasts more than 3 days, new symptoms arise, or if there is any redness or swelling, as these may indicate a serious condition.

Get Emergency Medical Help In cases of overdose, immediate medical help should be sought, or a Poison Control Center should be contacted without delay. Quick medical intervention is essential for both adults and children, regardless of the presence of symptoms.

Side Effects

Patients using this product should be aware of the potential for serious adverse reactions, particularly related to liver health. The product contains acetaminophen, and severe liver damage may occur if an adult exceeds 4,000 mg in a 24-hour period, which is the maximum recommended daily amount. Additionally, children should not take more than 5 tablets in a 24-hour period. The risk of liver damage is further heightened if the product is taken in conjunction with other medications containing acetaminophen or if an adult consumes 3 or more alcoholic drinks while using this product.

Patients are advised to stop use and consult a doctor if pain worsens or persists for more than 10 days in adults or more than 5 days in children. A fever that worsens or lasts more than 3 days, the emergence of new symptoms, or the presence of redness or swelling may indicate a serious condition and warrants medical attention.

Before using this product, individuals with liver disease should seek medical advice. Furthermore, patients taking the blood-thinning medication warfarin should consult a doctor or pharmacist prior to use to avoid potential interactions.

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 this medication is used in conjunction with warfarin, a blood-thinning agent. It is recommended that patients consult with a healthcare professional, such as a doctor or pharmacist, prior to using this medication if they are currently taking warfarin. Monitoring of coagulation parameters may be necessary to ensure patient safety and to adjust dosages accordingly.

Packaging & NDC

Below are the non-prescription pack sizes of Acetaminophen 325 mg (acetaminophen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 6 years of age should not use this medication. For children aged 6 to 11 years, the recommended dosage is 1 tablet every 4 to 6 hours as needed, with a maximum of 5 tablets in a 24-hour period. In contrast, adults and children aged 12 years and older may take 2 tablets every 4 to 6 hours, not exceeding 12 tablets in 24 hours.

Healthcare professionals should advise caregivers to discontinue use and consult a doctor if a child's pain worsens or persists for more than 5 days, or if a child's fever worsens or lasts more than 3 days. Additionally, it is important to note that quick medical attention is critical in cases of overdose in children, even if no signs or symptoms are immediately apparent.

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.

In the event of an overdose, prompt medical attention is essential for elderly patients, as well as for children, even if no immediate signs or symptoms are apparent. This precaution underscores the importance of monitoring and managing the health of geriatric patients when using this medication.

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, as well as any available data regarding fetal outcomes and lactation. Healthcare providers can offer guidance tailored to individual circumstances, ensuring the safety of both the patient and the developing fetus or nursing 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 not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the overall clinical context when prescribing to patients with renal impairment, as the lack of specific guidance necessitates individualized assessment and monitoring.

Hepatic Impairment

Patients with hepatic impairment should be closely monitored when using this product, which contains acetaminophen. Severe liver damage may occur if the following conditions are met:

• An adult consumes more than 4,000 mg of acetaminophen within a 24-hour period, which is the maximum daily dosage.

• A child takes more than 5 tablets in a 24-hour period, which is also the maximum daily dosage for pediatric patients.

• The product is taken concurrently with other medications that contain acetaminophen.

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

Due to the potential for increased risk of liver damage, it is recommended that patients with compromised liver function adhere strictly to the prescribed dosage and avoid the use of additional acetaminophen-containing products. Regular monitoring of liver function tests may be warranted in these patients to ensure safety and prevent adverse effects.

Overdosage

In cases of overdosage, significant health risks are associated with the consumption of this product beyond the recommended limits.

Adult Overdosage Severe liver damage may occur if an adult ingests more than 4,000 mg of the active ingredient within a 24-hour period, which is established as the maximum daily dosage. Additionally, the risk of liver damage is heightened if the product is taken concurrently with other medications containing acetaminophen. Furthermore, the consumption of three or more alcoholic beverages while using this product can also lead to severe liver damage.

Pediatric Overdosage For pediatric patients, severe liver damage may occur if a child takes more than five tablets within a 24-hour timeframe, which is the maximum daily amount for this demographic.

Healthcare professionals are advised to monitor patients closely for symptoms of liver damage in cases of suspected overdosage and to initiate appropriate management procedures as necessary.

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 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 keep this medication out of reach of children to prevent accidental ingestion. It is important to inform patients about the risks associated with overdose, emphasizing that taking more than the recommended dose may lead to liver damage. In the event of an overdose, patients should seek medical help or contact a Poison Control Center immediately, as prompt medical attention is crucial for both adults and children, even if no signs or symptoms are apparent.

Patients should be cautioned against using this medication in conjunction with any other drug that contains 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 for clarification.

Healthcare providers should instruct patients to discontinue use and seek medical advice if any of the following occur: pain worsens or persists for more than 10 days in adults, pain worsens or lasts more than 5 days in children, fever worsens or lasts more than 3 days, new symptoms arise, or if there is any redness or swelling. These symptoms may indicate a serious condition that requires further evaluation.

Additionally, patients should be advised to consult a doctor before using this medication if they have a history of liver disease. It is also recommended that patients taking the blood-thinning medication warfarin discuss their use of this medication with a doctor or pharmacist prior to starting treatment.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at a temperature range of 15° to 30°C (59° to 86°F) to maintain its efficacy and stability. Proper container requirements should be adhered to, ensuring that the product is kept in a suitable environment. Special handling needs must be observed to prevent any compromise to the product's integrity during storage and transportation.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

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