Non-Aspirin

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with headache, sore throat, flu, toothache, and 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

This product is intended for use in pediatric patients, and healthcare professionals should refer to the dosage chart to determine the appropriate dose based on the patient's weight or age. It is essential to adhere to the following guidelines for administration:

• The recommended dosing intervals are every 4 hours as needed while symptoms persist. However, the total number of doses should not exceed 5 times within a 24-hour period.

• Treatment should not extend beyond 5 consecutive days unless directed by a physician.

• For optimal administration, tablets must be chewed or crushed completely before swallowing; they should not be swallowed whole.

Dosage Chart:

• For patients weighing under 24 lb or under 2 years of age, consultation with a doctor is advised.

• For patients weighing 24-35 lb (2-3 years): administer 1 chewable tablet.

• For patients weighing 36-47 lb (4-5 years): administer 1 ½ chewable tablets.

• For patients weighing 48-59 lb (6-8 years): administer 2 chewable tablets.

• For patients weighing 60-71 lb (9-10 years): administer 2 ½ chewable tablets.

• For patients weighing 72-95 lb (11 years): administer 3 chewable tablets.

Dosage may be adjusted as directed by a healthcare professional. It is crucial to ensure that the patient does not exceed the maximum recommended doses to avoid potential adverse effects.

Contraindications

Use of this product is contraindicated in the following situations:

• Co-administration with any other drug containing acetaminophen, whether prescription or nonprescription, is prohibited. If there is uncertainty regarding the presence of acetaminophen in other medications, consultation with a healthcare professional is advised.

• This product should not be administered to children with a known allergy to acetaminophen or any of the inactive ingredients contained in the formulation.

• Exceeding the recommended dosage is contraindicated.

Warnings and Precautions

This product contains acetaminophen, which poses a risk of severe liver damage if the maximum daily dosage is exceeded. Specifically, healthcare professionals should advise caregivers that no more than five doses should be administered within a 24-hour period. Additionally, caution is warranted when this product is used concurrently with other medications containing acetaminophen, as this may further increase the risk of liver injury.

Severe skin reactions have been associated with acetaminophen use. Symptoms indicative of such reactions may include skin reddening, blisters, and rash. In the event of any skin reaction, it is imperative to discontinue use immediately and seek medical assistance.

Healthcare providers should also be vigilant regarding sore throat symptoms. If a child presents with a severe sore throat that persists for more than two days, or if it is accompanied by fever, headache, rash, nausea, or vomiting, prompt consultation with a physician is recommended.

Before administering this product, it is advisable to consult a healthcare professional if the child has a history of liver disease. Furthermore, caregivers should seek guidance from a doctor or pharmacist if the child is concurrently taking warfarin, a blood-thinning medication, to avoid potential interactions.

In cases of overdose, immediate medical attention is crucial. Caregivers should be instructed to contact a Poison Control Center or seek emergency medical help without delay, regardless of whether any signs or symptoms are apparent.

Healthcare professionals should advise caregivers to discontinue use and consult a physician if any of the following occur: worsening pain that lasts more than five days, a fever that worsens or persists beyond three days, the emergence of new symptoms, or the presence of redness or swelling. These may indicate a serious underlying condition that requires further evaluation.

Side Effects

Patients using this product should be aware of several important warnings and potential adverse reactions.

Severe liver damage may occur in patients who exceed the maximum daily dosage of acetaminophen, which is five doses within a 24-hour period. Additionally, the risk of liver damage increases if the product is taken concurrently with other medications containing acetaminophen.

Patients should also be alert for severe skin reactions associated with acetaminophen use. Symptoms of such reactions may include skin reddening, blisters, and rash. If any of these symptoms occur, patients are advised to discontinue use immediately and seek medical assistance.

In cases where a sore throat is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, patients should consult a healthcare professional promptly.

Patients are advised to stop using the product and seek medical advice if pain worsens or lasts longer than five days, if fever worsens or lasts more than three days, if new symptoms develop, or if there is any redness or swelling present. These symptoms may indicate a serious underlying condition that requires medical evaluation.

Drug Interactions

Co-administration of this medication with any other drug containing acetaminophen, whether prescription or nonprescription, is contraindicated. Patients should be advised to consult a healthcare professional if there is uncertainty regarding the presence of acetaminophen in other medications.

In pediatric patients, caution is advised when considering the use of this medication in conjunction with warfarin, a blood-thinning agent. It is recommended that a healthcare provider be consulted prior to use to assess potential interactions and the need for monitoring.

Additionally, it is important to seek medical advice before administering this medication to children with liver disease, as the safety and efficacy may be affected in this population.

Packaging & NDC

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

Pediatric Use

Pediatric patients should not exceed the recommended dosage of this product. The appropriate dose can be determined using the dosage chart provided, which recommends dosing based on weight when possible; otherwise, age may be used. The following dosing guidelines apply:

• Under 24 lb (Under 2 years): Consult a doctor.

• 24-35 lb (2-3 years): 1 tablet.

• 36-47 lb (4-5 years): 1 1/2 tablets.

• 48-59 lb (6-8 years): 2 tablets.

• 60-71 lb (9-10 years): 2 1/2 tablets.

• 72-95 lb (11 years): 3 tablets.

Tablets should be chewed or crushed completely before swallowing; they must not be swallowed whole. Doses may be repeated every 4 hours as needed, but should not exceed 5 doses in a 24-hour period or be administered for more than 5 consecutive days unless directed by a physician.

Caution is advised regarding liver health, as severe liver damage may occur if the maximum daily amount of 5 doses is exceeded or if used concurrently with other medications containing acetaminophen. Parents should not administer this product if their child has a known allergy to acetaminophen or any inactive ingredients. Consultation with a healthcare provider is recommended if the child has liver disease or is taking the anticoagulant warfarin.

This product should be kept out of reach of children. In the event of an overdose, immediate medical assistance should be sought, and contacting a Poison Control Center is essential, as prompt attention is critical for both children and adults, even in the absence of symptoms.

Geriatric Use

Elderly patients should be aware that this product does not contain specific directions or complete warnings for adult use. It is crucial for geriatric patients to adhere strictly to the recommended dosage and not exceed it.

In the event of an overdose, it is imperative to seek medical assistance or contact a Poison Control Center immediately. Prompt medical attention is essential for adults, including elderly patients, even if no signs or symptoms of overdose are apparent. Careful monitoring and adherence to dosage guidelines are recommended to ensure the safety and well-being of geriatric patients.

Pregnancy

Pregnant patients should be advised against the use of this product in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription. It is essential for healthcare providers to counsel women of childbearing potential to consult a doctor or pharmacist if there is uncertainty regarding the presence of acetaminophen in other medications.

In cases where the pregnant patient has a history of liver disease, it is imperative to seek medical advice prior to using this product. Additionally, if the patient is taking anticoagulants such as warfarin, consultation with a healthcare professional is recommended before use.

While using this product, pregnant patients must adhere to the recommended dosage and should not exceed it. They should be instructed to discontinue use and seek medical attention if pain worsens or persists beyond 5 days, if fever intensifies or lasts more than 3 days, if new symptoms arise, or if there is any presence of redness or swelling, as these may indicate a serious underlying condition.

Lactation

There are no specific statements regarding the use of this medication in nursing mothers or its effects on lactation. Additionally, there is no available data on the excretion of this medication in breast milk or its potential effects on breastfed infants. Healthcare professionals should consider the absence of information when advising lactating mothers about the use of this medication.

Renal Impairment

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data 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 be closely monitored when using this product, as it contains acetaminophen, which is associated with the risk of severe liver damage. It is critical to adhere to the maximum daily dosage of 5 doses within a 24-hour period to mitigate the risk of hepatotoxicity.

Before administration, it is advised to consult a healthcare professional if the patient has a history of liver disease. This precaution is essential to ensure the safe use of the product and to evaluate the need for any dosage adjustments or additional monitoring based on the severity of the hepatic impairment.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. 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 lack of immediate symptoms does not preclude the potential for serious health consequences. Therefore, it is essential to monitor the patient closely and provide appropriate care as needed.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects were identified in the available data. Additionally, there are no details regarding nonclinical toxicology or animal pharmacology and toxicology provided in the text.

Postmarketing Experience

No specific postmarketing experience details have been reported. As such, there are no additional adverse events or rare case reports to summarize at this time.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center in the event of an overdose, as prompt medical attention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Patients should be informed not to use this product in conjunction with any other medications that contain acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in another medication, patients are encouraged to consult with a doctor or pharmacist.

It is essential to inform patients that this product should not be used if their child has a known allergy to acetaminophen or any of the inactive ingredients contained in the formulation.

Patients should be instructed to discontinue use and consult a doctor if pain worsens or persists for more than five days. Similarly, they should stop use and seek medical advice if fever intensifies or lasts longer than three days, if new symptoms arise, or if there is any redness or swelling, as these may indicate a serious condition.

When using this product, patients must be cautioned against exceeding the recommended dosage. Additionally, healthcare providers should advise patients to consult a doctor before use if their child has liver disease. It is also important to recommend that patients speak with a doctor or pharmacist prior to use if their child is currently taking the blood-thinning medication warfarin.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers, which can be found on the packaging. It should be stored at a controlled room temperature of 25ºC (77ºF), with permissible excursions between 15ºC and 30ºC (59ºF to 86ºF). Care should be taken to avoid high humidity conditions during storage. For reference, the expiration date and lot number are located on the end flap of the packaging.

Additional Clinical Information

Patients should be advised on the proper administration of the medication, which includes repeating doses every 4 hours while symptoms persist, with a maximum of 5 doses within a 24-hour period. The medication should not be used for more than 5 consecutive days unless directed by a healthcare professional.

In the event of an overdose, it is crucial for patients to seek immediate medical assistance or contact a Poison Control Center, as prompt attention is essential for both adults and children, even if no symptoms are apparent.

Drug Information (PDF)

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

View product document (PDF)