Acetaminophen

Description

The product is available in three package sizes: 4 ounces, 8 ounces, and 16 ounces. Each package is designed to provide a specific volume of the formulation, ensuring appropriate dosing and usage for various applications.

Uses and Indications

This drug is indicated for the reduction of fever and the relief of minor aches and pains associated with various conditions, including the common cold, influenza, headache, sore throat, and toothache.

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.

Prior to administration, the product must be shaken well. The enclosed dosing cup, specifically designed for this product, should be utilized for accurate dosing; no other dosing devices should be employed.

The recommended dosing intervals are as follows: if necessary, the dose may be repeated every 4 hours while symptoms persist. However, it is imperative not to exceed 5 doses within a 24-hour period. Additionally, the product should not be administered for more than 5 consecutive days unless directed by a physician.

Dosage Chart:

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

• For patients weighing 24 to 35 lbs. and aged 2 to 3 years, the recommended dose is 1 teaspoon (5 mL).

• For patients weighing 36 to 47 lbs. and aged 4 to 5 years, the recommended dose is 1 ½ teaspoons (7.5 mL).

• For patients weighing 48 to 59 lbs. and aged 6 to 8 years, the recommended dose is 2 teaspoons (10 mL).

• For patients weighing 60 to 71 lbs. and aged 9 to 10 years, the recommended dose is 2 ½ teaspoons (12.5 mL).

• For patients weighing 72 to 95 lbs. and aged 11 years, the recommended dose is 3 teaspoons (15 mL).

Healthcare professionals should ensure that these guidelines are followed to promote safe and effective use of the product.

Contraindications

Use of this product is contraindicated in the following situations:

• Co-administration with any other drug containing acetaminophen, whether prescription or non-prescription, 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.

• In patients with a known allergy to acetaminophen or any of the inactive ingredients in this formulation, as this may lead to severe allergic reactions.

• Exceeding the recommended dosage is contraindicated, as it may result in serious adverse effects.

Warnings and Precautions

This product contains acetaminophen, which poses significant risks if not used according to guidelines. Severe liver damage may occur if a child exceeds five doses within a 24-hour period, which is the maximum daily amount, or if acetaminophen is taken concurrently with other medications containing acetaminophen.

Allergy Alert Acetaminophen may lead to severe skin reactions. Symptoms indicative of such reactions include skin reddening, blisters, and rash. In the event of a skin reaction, it is imperative to discontinue use immediately and seek medical assistance.

General Precautions Healthcare professionals should advise caregivers to consult a doctor prior to use if the child has a history of liver disease. Additionally, it is essential to inquire about any concurrent use of blood-thinning medications, such as warfarin, and to seek guidance from a doctor or pharmacist in such cases.

Emergency Medical Help In the event of an overdose, immediate medical attention is crucial. Caregivers should contact a Poison Control Center at 1-800-222-1222 or seek emergency medical help without delay, even if no signs or symptoms are apparent.

Monitoring and Follow-Up Caregivers should be instructed to stop the medication and consult a doctor if any of the following occur: pain worsens or persists beyond five days, fever intensifies or lasts more than three days, new symptoms develop, or if redness or swelling is observed. These symptoms may indicate a serious underlying condition that requires further evaluation.

Side Effects

Severe adverse reactions associated with this product include the potential for severe liver damage, particularly in patients who exceed the maximum daily dosage of 5 doses within a 24-hour period or who concurrently use other medications containing acetaminophen. Patients should be aware that acetaminophen may also lead to severe skin reactions, which can manifest as skin reddening, blisters, or rash. In the event of any skin reaction, it is imperative to discontinue use and seek immediate medical assistance.

Patients experiencing a severe sore throat that persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, should consult a healthcare professional promptly.

This product should not be used in conjunction with any other medications containing acetaminophen, whether prescription or non-prescription. Patients should verify the presence of acetaminophen in other medications with a healthcare provider or pharmacist if uncertain. Additionally, this product is contraindicated in patients with a known allergy to acetaminophen or any of the inactive ingredients.

Patients with liver disease should consult a doctor before using this product. Furthermore, those taking the anticoagulant warfarin should seek advice from a healthcare professional or pharmacist prior to use.

While using this product, it is crucial not to exceed the recommended dosage. Patients should discontinue use and consult a doctor if pain worsens or persists beyond 5 days, if fever worsens or lasts more than 3 days, if new symptoms arise, or if redness or swelling occurs, as these may indicate a serious condition.

In the event of an overdose, immediate medical attention is necessary. Patients should contact a Poison Control Center (1-800-222-1222) without delay, even if no signs or symptoms are apparent, as prompt medical intervention is critical.

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 toxicity. If there is uncertainty regarding the presence of acetaminophen in other medications, it is advisable to seek guidance from a healthcare provider.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 2 years of age (weighing less than 24 lbs) should consult a healthcare professional before use. Recommended dosages for children based on age and weight are as follows: for those weighing 24 to 35 lbs (ages 2 to 3 years), the dosage is 1 teaspoon (5 mL); for 36 to 47 lbs (ages 4 to 5 years), the dosage is 1 1/2 teaspoons (7.5 mL); for 48 to 59 lbs (ages 6 to 8 years), the dosage is 2 teaspoons (10 mL); for 60 to 71 lbs (ages 9 to 10 years), the dosage is 2 1/2 teaspoons (12.5 mL); and for 72 to 95 lbs (age 11 years), the dosage is 3 teaspoons (15 mL).

It is important not to exceed 5 doses within a 24-hour period and to limit use to no more than 5 days unless directed by a healthcare professional. Additionally, a healthcare professional should be consulted if the pediatric patient has liver disease or is taking the anticoagulant warfarin.

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

There are no specific warnings or precautions regarding the use of acetaminophen elixir during pregnancy. The prescribing information does not indicate whether the product is contraindicated in pregnant patients or if there are any associated risks to the fetus. Additionally, no dosage modifications or special precautions for individuals who are pregnant are provided in the insert. Healthcare professionals should consider the overall clinical context when recommending this medication to pregnant patients.

Lactation

There are no specific warnings or recommendations regarding the use of acetaminophen in lactating mothers. Additionally, the prescribing information does not provide statements concerning the potential for excretion of acetaminophen in breast milk or any associated risks to breastfed infants.

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, particularly if they have a history of liver disease. It is essential to evaluate liver function and consider potential adjustments in dosage or monitoring requirements based on the severity of the impairment. Careful assessment and ongoing monitoring may be necessary to ensure safety and efficacy in this population.

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, even in the absence of noticeable signs or symptoms. Healthcare professionals should be aware that early recognition and management of overdose can significantly impact patient outcomes.

It is essential to monitor the patient closely for any potential symptoms that may arise following an overdose. The specific manifestations can vary depending on the substance involved, and healthcare providers should be prepared to implement appropriate management strategies based on the clinical presentation.

In summary, the key actions in the case of an overdose include obtaining urgent medical help and maintaining vigilance for any developing symptoms, ensuring that the patient receives the necessary care without delay.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

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. It is important to inform patients not to use this product in conjunction with any other medications that contain acetaminophen, whether prescription or non-prescription. If patients are uncertain about the presence of acetaminophen in other medications, they should be encouraged to consult with a doctor or pharmacist.

Patients should be cautioned against using this product if their child has a known allergy to acetaminophen or any of the inactive ingredients contained in the formulation. Healthcare providers should instruct patients to discontinue use and seek medical advice if any of the following occur: pain worsens or persists for more than 5 days, fever worsens or lasts more than 3 days, new symptoms develop, or if there is any redness or swelling, as these may indicate a serious condition.

While using this product, patients must be reminded not to exceed the recommended dosage. Additionally, healthcare providers should recommend that patients consult a doctor before use if their child has liver disease. It is also advisable for patients to 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 various package configurations, with specific NDC numbers available upon request. It should be stored at room temperature, within the range of 15° to 30° C (59° to 86° F). Care must be taken to protect the product from freezing, as well as from exposure to light to ensure its integrity and efficacy.

Additional Clinical Information

No further data are available.

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)