Careall Acetaminophen

Description

No description information is available for the specified drug.

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 from 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 12 years of age and older are instructed 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, the use of this medication should not extend beyond 10 days unless specifically advised by a doctor.

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 must not surpass 5 tablets, and the duration of use should not exceed 5 days unless directed by a healthcare provider.

For children under 6 years of age, it is advised to consult a doctor before administration.

Contraindications

There are no contraindications associated with the use of this product. It is not classified as a controlled substance, and there are no identified risks of abuse, misuse, or dependence. Therefore, no specific instructions regarding avoidance or non-use are necessary.

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, it is restricted to 5 tablets (1,625 mg) in the same timeframe.

Liver Warning Severe liver damage may occur under the following circumstances:

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

• A child takes more than 5 doses in 24 hours.

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

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

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

General Precautions This product should not be used in conjunction with any other medications containing acetaminophen, whether prescription or nonprescription. Individuals with a known allergy to acetaminophen should also refrain from using this product. Prior to use, it is advisable to consult a healthcare professional if the user has liver disease. Additionally, consultation with a doctor or pharmacist is recommended if the user is taking the anticoagulant warfarin or if the user is a child experiencing pain associated with arthritis.

Emergency Medical Help In the event of an overdose, immediate medical attention is required. Contact a Poison Control Center at 1-800-222-1222 without delay. Prompt medical intervention is crucial for both adults and children, even if no signs or symptoms are apparent.

Discontinuation of Use Users should stop taking this product and consult a healthcare provider if:

• An adult's pain worsens or persists for more than 10 days.

• A child's pain worsens or lasts longer than 5 days.

• Fever worsens or continues for more than 3 days.

• New symptoms develop.

• Redness or swelling is observed.

Side Effects

Severe liver damage may occur in patients who exceed the recommended dosage of acetaminophen. Specifically, adults should not take more than 4,000 mg in a 24-hour period, and children should not take more than 5 doses within the same timeframe. The risk of liver damage is heightened if acetaminophen is taken in conjunction with other medications containing acetaminophen or if an adult consumes 3 or more alcoholic drinks daily while using this product.

Patients should be aware of the potential for severe skin reactions associated with acetaminophen, which may manifest as skin reddening, blisters, or rash. In the event of a skin reaction, it is imperative to discontinue use and seek medical assistance immediately.

Acetaminophen should not be used in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription. Additionally, individuals with a known allergy to acetaminophen should avoid its use.

Before using this product, patients with liver disease should consult a healthcare professional. Furthermore, individuals taking the blood-thinning medication warfarin or children experiencing pain from arthritis should also seek advice from a doctor or pharmacist prior to use.

Patients are advised to discontinue use and consult a healthcare provider if their pain worsens or persists for more than 10 days in adults or more than 5 days in children. Additionally, if fever worsens or lasts for more than 3 days, or if new symptoms arise, medical consultation is recommended. Signs of redness or swelling should also prompt a discussion with a healthcare professional.

In cases of overdose, which may occur if the recommended dose is exceeded, patients should seek immediate medical help or contact a Poison Control Center (1-800-222-1222). Prompt medical intervention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Drug Interactions

Acetaminophen has been shown to enhance the anticoagulant effect of warfarin, which may result in an elevated risk of bleeding complications. It is recommended that the International Normalized Ratio (INR) be monitored closely in patients receiving both acetaminophen and warfarin to ensure safe and effective management of anticoagulation therapy.

No additional drug interactions or interactions with laboratory tests have been identified.

Packaging & NDC

Below are the non-prescription pack sizes of Careall Acetaminophen (acetaminophen). 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 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.

The maximum daily dose for pediatric patients is limited to 5 doses within a 24-hour timeframe. It is essential to seek immediate medical attention in the event of an overdose, even if the child exhibits no signs or symptoms, due to potential safety concerns.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. 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 efficacy, given the lack of targeted data for 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 the use of this drug during pregnancy and lactation. Healthcare providers can offer guidance based on individual circumstances and the latest clinical data.

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 mothers.

Renal Impairment

Patients with renal impairment may not have specific information regarding dosage adjustments, special monitoring, or safety considerations outlined in the prescribing information. 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 and monitoring of these patients.

Hepatic Impairment

Patients with hepatic impairment should consult a healthcare professional prior to use, particularly if they have a history of liver disease. It is important to note that exceeding the recommended dosage may lead to liver damage, underscoring the necessity for careful adherence to dosing guidelines in this population. Monitoring of liver function may be warranted in patients with compromised liver function to ensure safety and efficacy of treatment.

Overdosage

In the event of an overdose, defined as the ingestion of more than the recommended dose, there is a significant risk of liver damage. It is imperative that healthcare professionals recognize the seriousness of this situation and act swiftly.

Immediate medical assistance is crucial. In cases of suspected overdose, individuals should seek medical help or contact a Poison Control Center at 1-800-222-1222 without delay. This action is essential for both adults and children, as prompt intervention can mitigate potential harm, even in the absence of noticeable signs or symptoms.

Healthcare providers should remain vigilant and ensure that patients and caregivers are aware of the importance of quick medical response in the event of an 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 understanding of potential risks associated with the compound in these areas.

Postmarketing Experience

Acetaminophen has been associated with severe skin reactions in postmarketing experience. Reports indicate that symptoms may include skin reddening, blisters, or 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 the medication out of reach of children to prevent accidental ingestion. It is essential to emphasize the importance of safety in the home environment, particularly for families with young children.

In the event of an overdose, healthcare providers should instruct patients to contact a doctor or the Poison Control Center immediately. They should stress that quick medical attention is critical for both adults and children, even if no signs or symptoms of overdose are apparent. This proactive approach can help ensure timely intervention and mitigate potential health risks associated with overdose.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers, which should be referenced for accurate identification. It is essential to store the product at room temperature, maintaining a range of 20°C to 25°C (68°F to 77°F).

To ensure the integrity of the product, it must be protected from light exposure. Additionally, it is crucial to keep the product out of reach of children to prevent accidental ingestion. Once opened, the product should be discarded to ensure safety and efficacy.

Additional Clinical Information

Adults and children aged 12 years and older are advised to take 2 tablets every 4 to 6 hours as needed, with a maximum of 10 tablets in a 24-hour period unless directed otherwise by a physician. This medication should not be used for more than 10 days without medical guidance. For children aged 6 to 11 years, the recommended dosage is 1 tablet every 4 to 6 hours, not exceeding 5 tablets in 24 hours, and should not be used for more than 5 days unless directed by a healthcare provider. For children under 6 years of age, consultation with a doctor is recommended prior to use.

Clinicians should counsel patients to seek advice from a healthcare professional if they are pregnant or breastfeeding. An overdose warning is in place, as exceeding the recommended dosage may lead to liver damage. In the event of an overdose, immediate medical assistance should be sought, and contacting a Poison Control Center (1-800-222-1222) is advised, as prompt action is crucial for both adults and children, regardless of the presence of symptoms.

Drug Information (PDF)

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

View product document (PDF)