Amazon Basic Care Acetaminophen

Description

Acetaminophen Extended-Release Tablets USP are formulated to provide effective pain relief and fever reduction. Each tablet contains 650 mg of acetaminophen, designed for the management of minor muscle aches and pain. The dosage form is capsule-shaped tablets, allowing for extended release of the active ingredient for up to 8 hours of relief. This product is available in a package containing 100 caplets.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various conditions, including muscular aches, backache, minor pain of arthritis, toothache, premenstrual and menstrual cramps, headache, and discomfort related to the common cold. 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 8 hours with water. The tablets should be swallowed whole and must not be crushed, chewed, split, or dissolved. The maximum dosage should not exceed 6 tablets within a 24-hour period. Additionally, the use of this medication should not extend beyond 10 days unless directed by a healthcare professional.

For children under 12 years of age, the use of this medication is not recommended.

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 specific warnings and precautions that healthcare professionals must communicate to patients to ensure safe use.

Liver Warning Severe liver damage may occur if the patient exceeds the maximum daily dosage of 6 tablets within a 24-hour period. Caution is advised when this product is taken in conjunction with other medications containing acetaminophen. Additionally, patients should be informed that consuming 3 or more alcoholic drinks daily while using this product increases the risk of liver damage.

Allergy Alert Acetaminophen may lead to severe skin reactions. Symptoms indicative of such reactions include skin reddening, blisters, and rash. Should any of these symptoms manifest, patients must discontinue use immediately and seek medical assistance.

Emergency Medical Help In the event of an overdose, it is imperative to obtain emergency medical help or contact a Poison Control Center without delay at 1-800-222-1222.

Monitoring and Consultation Patients should be advised to stop taking the product and consult their 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 arise, or if redness or swelling is observed. These symptoms may indicate a serious underlying condition. Furthermore, pregnant or breastfeeding patients should seek guidance from a healthcare professional prior to use.

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. The product contains acetaminophen, which can lead to severe liver damage if the maximum daily dosage of 6 tablets is exceeded, if it is taken concurrently with other medications containing acetaminophen, or if consumed with three or more alcoholic drinks daily.

In addition to liver-related concerns, patients should be vigilant for signs of severe skin reactions, which may manifest as skin reddening, blisters, or rash. Should any of these symptoms occur, 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 pain worsens or persists beyond 10 days, if fever intensifies or lasts more than 3 days, if new symptoms arise, or if there is any redness or swelling. These symptoms may indicate a serious underlying condition. Furthermore, individuals who are pregnant or breastfeeding should consult a healthcare provider prior to using this product.

Drug Interactions

Patients should consult a healthcare professional prior to using this medication if they are concurrently taking warfarin, a blood-thinning agent. The combination may increase the risk of bleeding due to potential pharmacodynamic interactions.

Additionally, this medication should not be used in conjunction with any other products containing acetaminophen, whether prescription or over-the-counter. Co-administration may lead to an increased risk of acetaminophen-related hepatotoxicity. If there is uncertainty regarding the presence of acetaminophen in other medications, patients are advised to seek guidance from a healthcare provider.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 12 years of age should not use this medication. For adolescents aged 12 years and older, the recommended dosage is 2 tablets every 8 hours with water, with a maximum of 6 tablets in a 24-hour period. Treatment should not exceed 10 days unless directed by a healthcare professional.

In the event of an overdose, prompt medical attention is essential for both adults and pediatric patients, even if no signs or symptoms are immediately apparent.

Geriatric Use

Elderly patients may not have specific dosage adjustments, safety concerns, or special precautions outlined in the prescribing information. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any potential adverse effects or changes in therapeutic response, given the general considerations associated with pharmacotherapy in 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 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

There is no specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in this patient population.

Hepatic Impairment

Patients with hepatic impairment should be closely monitored when using this product, which contains acetaminophen. It is critical to adhere to the maximum daily dosage of 6 tablets within a 24-hour period to minimize the risk of severe liver damage.

Additionally, patients must be cautioned against the concurrent use of this product with other medications containing acetaminophen, as this may significantly increase the risk of liver injury.

Patients who consume three or more alcoholic drinks daily should exercise particular caution, as the combination of alcohol and acetaminophen can lead to severe liver damage. It is advisable for healthcare providers to evaluate liver function and consider alternative therapies for patients with compromised liver function to ensure safety and efficacy.

Overdosage

In cases of overdosage, significant health risks are associated with exceeding the recommended dosage of this product.

Risk of Liver Damage Taking more than 6 tablets within a 24-hour period, which is the maximum daily dosage, can lead to severe liver damage. Healthcare professionals should be vigilant in assessing patients who may have exceeded this limit.

Additionally, the concomitant use of this product with other medications containing acetaminophen poses a further risk of severe liver damage. It is crucial for healthcare providers to inquire about all medications a patient is taking to prevent potential interactions that could exacerbate liver toxicity.

Alcohol Consumption Patients who consume 3 or more alcoholic drinks daily while using this product are also at an increased risk for severe liver damage. Healthcare professionals should advise patients on the dangers of alcohol consumption during treatment and consider this factor when evaluating a patient's overall risk profile.

In the event of suspected overdosage, immediate medical attention is warranted. Monitoring liver function and providing supportive care are essential components of management.

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 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 seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 in the event of an overdose. It is important to emphasize that quick medical attention is critical for both adults and children, even if no signs or symptoms are initially apparent.

Patients should be encouraged to consult with their healthcare provider before using this medication if they have liver disease. Additionally, it is essential for patients to discuss any current medications, particularly blood thinners such as warfarin, with their doctor or pharmacist prior to use.

Healthcare providers should instruct patients to discontinue use and consult a doctor if their pain worsens or persists for more than 10 days. Similarly, patients should be advised to stop use and seek medical advice if their fever worsens or lasts longer than 3 days, if new symptoms arise, or if they notice any redness or swelling.

For patients who are pregnant or breastfeeding, it is crucial to recommend that they consult a health professional before using this medication to ensure safety for both themselves and their child.

Storage and Handling

The product is supplied in packaging that includes specific NDC numbers, which should be referenced for accurate identification. It is essential to store the product at a temperature range of 20°C to 25°C (68°F to 77°F). Care should be taken to avoid exposure to excessive heat, specifically temperatures exceeding 40°C (104°F).

Additionally, the integrity of the packaging is crucial; the product should not be used if the carton has been opened or if the foil inner seal is broken. Proper handling and storage conditions are vital to ensure the product's efficacy and safety.

Additional Clinical Information

Patients should be informed that the medication is administered orally. For adults and children aged 12 years and older, the recommended dosage is 2 tablets every 8 hours, with a maximum of 6 tablets in a 24-hour period. Tablets should be swallowed whole and not crushed, chewed, split, or dissolved. The use of this medication should not exceed 10 days unless directed by a healthcare professional.

Clinicians should counsel patients who are pregnant or breastfeeding to consult a health professional before use. Additionally, patients should be made aware of the overdose warning; in the event of an overdose, immediate medical assistance or contact with a Poison Control Center is essential, as prompt attention is critical for both adults and children, even if no symptoms are apparent.

Drug Information (PDF)

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

View product document (PDF)