Acetaminophen

Description

CAREONE ACETAMINOPHEN is formulated as a pain reliever and fever reducer, containing 325 mg of acetaminophen per softgel. This product is available in a package of 40 softgels. The National Drug Code (NDC) for this formulation is 41520-982-25. CAREONE ACETAMINOPHEN is comparable to the active ingredient found in TYLENOL® Regular Strength.

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 advised to take 2 softgels every 4 to 6 hours as needed for symptom relief. The maximum allowable dosage is 10 softgels within a 24-hour period. Continuous use should not exceed 10 days unless directed by a healthcare professional.

For children aged 6 to 11 years, the recommended dosage is 1 softgel every 4 to 6 hours while symptoms persist. The total daily intake should not exceed 5 softgels, and usage should not extend beyond 5 days unless specifically instructed by a physician.

For children under 6 years of age, it is recommended to consult a healthcare provider for appropriate dosing guidance.

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 poses significant risks for liver damage if not used according to the specified guidelines. The maximum daily dosage for adults is limited to 10 softgels (3,250 mg) within a 24-hour period, while for children, the maximum is 5 softgels (1,625 mg) in the same timeframe. Severe liver damage may occur if an adult exceeds 4,000 mg of acetaminophen in 24 hours, if a child takes more than the recommended 5 doses, if the product is taken concurrently with other medications containing acetaminophen, or if an adult consumes 3 or more alcoholic beverages daily while using this product.

In addition to the liver warning, there is an allergy alert associated with acetaminophen. It may lead to severe skin reactions, which can manifest as skin reddening, blisters, or rash. Should any of these symptoms occur, it is imperative to discontinue use immediately and seek medical assistance.

General precautions should be observed prior to use. Individuals with liver disease should consult a healthcare professional before using this product. Furthermore, it is advisable for patients taking the anticoagulant warfarin to consult with a doctor or pharmacist before use.

In the event of an overdose, immediate medical attention is crucial. Users should contact a Poison Control Center (1-800-222-1222) or seek emergency medical help without delay, regardless of the presence of symptoms.

Users are advised 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 under 12 years, fever worsens or lasts more than 3 days, new symptoms arise, or if redness or swelling is observed. These signs may indicate a serious underlying condition that requires medical evaluation.

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, while children should not exceed 5 doses within the same timeframe, which constitutes the maximum daily amount. The risk of liver damage is further heightened if acetaminophen is taken in conjunction with other medications containing acetaminophen or if an adult consumes three or more alcoholic drinks daily while using this product.

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

Patients are advised to stop using acetaminophen and consult a healthcare professional if pain worsens or persists beyond 10 days in adults, or if pain lasts more than 5 days in children under 12 years. Additionally, if fever worsens or lasts more than 3 days, or if new symptoms arise, medical advice should be sought. The presence of redness or swelling may indicate a serious condition, warranting immediate medical evaluation.

It is recommended that patients consult a doctor prior to using acetaminophen if they have a history of liver disease. Furthermore, individuals taking the blood-thinning medication warfarin should seek guidance from a healthcare provider or pharmacist before using acetaminophen.

Drug Interactions

Patients taking warfarin, a blood-thinning medication, should consult a healthcare professional prior to using this product. The interaction between this product and warfarin may alter the anticoagulant effect, necessitating careful monitoring of INR levels and potential dosage adjustments of warfarin to maintain therapeutic efficacy and safety.

Packaging & NDC

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

Pediatric Use

Pediatric patients may use this medication with specific dosing considerations. For children aged 6 to 11 years, the recommended dosage is 1 softgel every 4 to 6 hours as needed, with a maximum of 5 softgels (1,625 mg) in a 24-hour period. It is advised that this age group does not use the medication for more than 5 consecutive days unless directed by a healthcare professional.

For children under 6 years of age, it is essential to consult a doctor before use to ensure safety and appropriateness of treatment.

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 crucial for both elderly patients and children. Monitoring for signs of overdose and ensuring immediate access to medical care can significantly impact outcomes in these populations.

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 drug insert regarding dosage adjustments, special monitoring, or safety considerations. 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. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment should consult a healthcare professional prior to use. It is essential for individuals with liver disease to seek medical advice to determine the appropriateness of treatment and any necessary adjustments to dosage or monitoring requirements.

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 based on the specific substance involved in the overdose. Therefore, a thorough assessment and monitoring of the patient are essential.

Management procedures 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

Patients should be advised to keep this medication out of reach of children to prevent accidental ingestion. It is important to inform patients that they should not use this product in conjunction with any other medication containing acetaminophen, whether prescription or nonprescription. If patients are uncertain whether a drug contains acetaminophen, they should be encouraged to consult with a doctor or pharmacist.

Patients must be cautioned against using this medication if they have a known allergy to acetaminophen or any of the inactive ingredients present in the product. They 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, patients should be advised to stop use and consult a doctor if their fever worsens or lasts more than 3 days, if new symptoms arise, or if they notice any redness or swelling, as these may indicate a serious condition.

Patients with liver disease should be encouraged to consult a doctor before using this medication. Furthermore, it is essential to advise patients to speak with a doctor or pharmacist prior to use if they are currently taking the blood-thinning medication warfarin.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It should be stored at room temperature, within the range of 15° to 30°C (59° to 86°F). Care should be taken to ensure that the product is kept in a suitable container to maintain its integrity. Special handling requirements should be observed to prevent exposure to extreme temperatures or conditions that may compromise the product's quality.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. No additional information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

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)