Careall Non Aspirin

Description

No description information is available for the drug.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various conditions, including the common cold, headache, toothache, muscular aches, backache, minor pains of arthritis, and menstrual and premenstrual 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 advised to take 2 caplets every 4 to 6 hours as needed for symptom relief. The maximum dosage should not exceed 6 caplets within a 24-hour period. Continuous use beyond 10 days is not recommended unless directed by a healthcare professional.

For children under 12 years of age, it is essential to consult a doctor before administration.

Contraindications

There are no contraindications associated with the use of this product. It is deemed safe for use in the absence of specific conditions or situations that would warrant avoidance.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen. Healthcare professionals should advise patients to avoid exceeding 4000 mg of acetaminophen within a 24-hour period, to refrain from using other medications that contain acetaminophen concurrently, and to limit alcohol consumption to fewer than three drinks per day while using this product.

Acetaminophen has been associated with severe skin reactions, which may manifest as skin reddening, blisters, or rash. Should any of these symptoms occur, patients must discontinue use immediately and seek medical assistance.

This product should not be used in conjunction with any other medications containing acetaminophen, whether prescription or nonprescription. Patients uncertain about the acetaminophen content of their medications should be encouraged to consult a healthcare provider. Additionally, individuals with a known allergy to acetaminophen or any inactive ingredients in this formulation should avoid its use.

Prior to administration, it is essential for healthcare professionals to inquire about the patient's medical history, particularly regarding liver disease. Furthermore, patients taking the anticoagulant warfarin should consult with a doctor or pharmacist before using this product.

Patients should be instructed to discontinue use and consult a healthcare provider if pain worsens or persists for more than 10 days, if fever intensifies or lasts longer than 3 days, if new symptoms arise, or if there is any redness or swelling, as these may indicate a serious condition.

In the event of an overdose, immediate medical attention is crucial. Patients should be advised to contact emergency medical services or the Poison Control Center at 1-800-222-1222 without delay, as prompt intervention is vital for both adults and children, even in the absence of noticeable symptoms.

Side Effects

Severe liver damage may occur in patients who exceed 4000 mg of acetaminophen within a 24-hour period, use other medications containing acetaminophen, or consume three or more alcoholic drinks daily while using this product.

Patients should be aware that acetaminophen may cause 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 and seek medical assistance immediately.

This product should not be used in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription. Patients uncertain about the presence of acetaminophen in their medications are advised to consult a doctor or pharmacist. Additionally, individuals with a known allergy to acetaminophen or any inactive ingredients in this product should refrain from its use.

Before using this product, patients with liver disease should consult a doctor. Furthermore, it is recommended that patients taking the blood-thinning medication warfarin seek advice from a doctor or pharmacist prior to use.

Patients are advised to stop using the product and consult a doctor if pain worsens or persists for more than 10 days, if fever worsens or lasts longer than 3 days, if new symptoms arise, or if redness or swelling occurs, as these may indicate a serious condition.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there are no known interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Careall Non Aspirin (acetaminophen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional before use. For adolescents aged 12 years and older, the recommended dosage is 2 caplets every 4 to 6 hours as needed, with a maximum of 6 caplets in a 24-hour period. Treatment should not exceed 10 days unless directed by a healthcare provider.

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 adults and children aged 12 years and older, the recommended dosage is 2 caplets every 4 to 6 hours as needed, with a maximum of 6 caplets in a 24-hour period. It is advised that this medication not be used for more than 10 consecutive days unless directed by a healthcare professional.

For children under 12 years of age, it is essential to consult a doctor before administration. Careful monitoring and adherence to these guidelines are crucial to ensure the safety of elderly 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 maternal health. 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 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 not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring.

Hepatic Impairment

Patients with hepatic impairment should exercise caution when using this product, as it contains acetaminophen, which can lead to severe liver damage under certain conditions. Specifically, patients should not exceed 4000 mg of acetaminophen within a 24-hour period. Additionally, the concurrent use of other medications containing acetaminophen is contraindicated, as this may further increase the risk of liver injury.

Patients with compromised liver function are advised to consult a healthcare professional prior to using this product, particularly if they have a history of liver disease. Furthermore, it is recommended that patients limit alcohol consumption to fewer than three alcoholic drinks per day while using this product to mitigate the risk of liver damage. Regular monitoring of liver function may be warranted in patients with significant hepatic impairment to ensure safety and efficacy during treatment.

Overdosage

In cases of overdosage, it is critical to recognize the potential for severe liver damage associated with excessive intake of acetaminophen. Specifically, the risk of significant hepatic injury increases when the total daily dosage exceeds 4000 mg within a 24-hour period.

Recommended Actions

Healthcare professionals should promptly assess the patient's condition and consider the following management procedures:

1. Immediate Evaluation: Conduct a thorough clinical assessment to determine the extent of the overdose and the time of ingestion.

2. Supportive Care: Initiate supportive measures as necessary, including monitoring vital signs and providing symptomatic treatment.

3. Antidote Administration: If an acetaminophen overdose is confirmed, the administration of N-acetylcysteine (NAC) should be considered as it is the specific antidote for acetaminophen toxicity. The timing of NAC administration is crucial; it is most effective when given within 8 hours of ingestion.

Potential Symptoms

Patients may present with a range of symptoms that can vary in severity. Initial symptoms may include nausea, vomiting, loss of appetite, confusion, and jaundice, which can progress to more severe manifestations of liver failure if not addressed promptly.

In summary, vigilance in monitoring acetaminophen intake and awareness of the signs of overdose are essential for preventing severe hepatic complications. Immediate medical intervention is critical in managing acetaminophen overdosage effectively.

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.

In the event of an overdose, it is crucial for patients to seek medical help immediately or contact the Poison Control Center at 1-800-222-1222. Healthcare providers should emphasize that prompt medical attention is essential for both adults and children, even if no signs or symptoms of overdose are apparent.

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 caplets every 4 to 6 hours as needed, not exceeding 6 caplets in a 24-hour period, and should not use the product for more than 10 days unless directed by a physician. For children under 12 years of age, consultation with a doctor is recommended prior to use.

Clinicians should counsel patients to keep the medication out of reach of children and to seek immediate medical assistance in the event of an overdose, as prompt attention is crucial for both adults and children. Patients should be informed of the liver warning associated with acetaminophen, emphasizing that severe liver damage may occur if the daily limit of 4000 mg is exceeded, particularly when combined with other acetaminophen-containing products or excessive alcohol consumption. Additionally, patients should be alerted to the potential for severe skin reactions and advised to discontinue use and seek medical help if such symptoms arise. It is also important to consult a healthcare professional before use if the patient has liver disease, is taking warfarin, or is pregnant or breastfeeding. Patients should be instructed to stop use and consult a doctor if pain worsens or persists beyond 10 days, if fever worsens or lasts more than 3 days, or if new symptoms or signs of redness or swelling occur, as these may indicate a serious condition.

Drug Information (PDF)

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

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