Acetaminophen

Description

Acetaminophen Oral Suspension is formulated to deliver 80 mg of acetaminophen per 2.5 mL dose. This medication is intended for oral use only and is designed for hospital use exclusively. The product is alcohol-free, aspirin-free, gluten-free, and ibuprofen-free. It should be stored at a temperature range of 20-25°C (68-77°F). The packaging is provided by Precision Dose, Inc., located in South Beloit, IL 61080.

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

Healthcare professionals should administer the medication as directed. It is imperative not to exceed the recommended dosage, as an overdose may occur. Prior to administration, the solution must be shaken well.

Dosing should be determined using the chart provided below, with weight being the preferred method for dosing. If weight is not available, age may be used as an alternative. The medication may be repeated every 4 hours as needed while symptoms persist, but it should not be taken more than 5 times within a 24-hour period.

Dosage Chart:

• Weight (lb): Under 24 Age (yr): Under 2 years Dose (mL): Consult a doctor

• Weight (lb): 24-35 Age (yr): 2-3 years Dose (mL): 5 mL

• Weight (lb): 36-47 Age (yr): 4-5 years Dose (mL): 7.5 mL

• Weight (lb): 48-59 Age (yr): 6-8 years Dose (mL): 10 mL

• Weight (lb): 60-71 Age (yr): 9-10 years Dose (mL): 12.5 mL

• Weight (lb): 72-95 Age (yr): 11 years Dose (mL): 15 mL

• Weight (lb): Over 96 Age (yr): Adults and children 12 years and over Dose (mL): 20 mL

Contraindications

Use of this product is contraindicated in the following situations:

• Concurrent use with any other drug 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.

• In patients with a history of allergic reactions to this product or any of its ingredients.

Additionally, if pain worsens or persists beyond 10 days in adults or 5 days in children, if fever worsens or lasts more than 3 days, if new symptoms arise, or if redness or swelling is observed, the use of this product should be discontinued and a healthcare professional should be consulted. This product should not be administered to children for pain associated with arthritis unless specifically directed by a physician.

Exceeding the recommended dosage is contraindicated, as it may lead to overdose.

Warnings and Precautions

This product contains acetaminophen, which poses a risk of severe liver damage under certain conditions. Adults should not exceed 4,000 mg of acetaminophen within a 24-hour period. For children, the maximum is 5 doses in the same timeframe. Caution is advised when this product is taken in conjunction with other medications containing acetaminophen. Additionally, adults consuming three or more alcoholic drinks daily while using this product are at increased risk for liver damage.

Severe skin reactions have been 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 immediately and seek medical assistance.

Healthcare professionals should advise patients to consult a doctor if a sore throat is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting.

General precautions include advising patients to seek medical advice prior to use if they have liver disease. Furthermore, individuals taking the anticoagulant warfarin should consult a doctor or pharmacist before using this product. It is essential that users do not exceed the recommended dosage.

In cases of overdose, immediate medical attention is crucial. Patients should contact a Poison Control Center at 1-800-222-1222 without delay, regardless of the presence of symptoms.

Patients should discontinue use and consult a doctor if any of the following occur: pain worsens or persists beyond 10 days for adults or 5 days for children; fever worsens or lasts more than 3 days; new symptoms arise; or if redness or swelling is observed. It is also advised not to administer this product to children for arthritis pain unless specifically directed by a healthcare professional.

Side Effects

Severe adverse reactions associated with this product include significant liver damage, which may occur if an adult consumes more than 4,000 mg of acetaminophen within a 24-hour period, if a child takes more than five doses in 24 hours, if the product is used concurrently 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, which may 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.

Participants are advised to stop use and consult a healthcare professional if pain worsens or persists beyond 10 days for adults or 5 days for children, if fever intensifies or lasts more than 3 days, if new symptoms arise, or if redness or swelling is observed, as these may indicate a serious underlying condition. It is also recommended that this product not be administered to children for the treatment of arthritis pain unless specifically directed by a physician.

Prior to use, individuals should consult a healthcare provider if they have a history of liver disease. Additionally, it is advisable to seek guidance from a doctor or pharmacist if the patient is concurrently taking the anticoagulant medication warfarin.

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 should not be given this product for arthritis pain unless directed by a healthcare professional. Dosing varies by weight and age, as follows:

• For patients under 24 lb (under 2 years), consult a doctor for appropriate dosing.

• For patients weighing 24-35 lb (2-3 years), the recommended dose is 5 mL.

• For patients weighing 36-47 lb (4-5 years), the recommended dose is 7.5 mL.

• For patients weighing 48-59 lb (6-8 years), the recommended dose is 10 mL.

• For patients weighing 60-71 lb (9-10 years), the recommended dose is 12.5 mL.

• For patients weighing 72-95 lb (11 years), the recommended dose is 15 mL.

• For patients over 96 lb, including adults and children 12 years and older, the recommended dose is 20 mL.

If pain worsens or persists for more than 5 days, or if fever worsens or lasts more than 3 days, parents or caregivers should consult a doctor promptly. In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center, as quick medical attention is critical for both children and adults, even if no signs or symptoms are present.

Geriatric Use

Elderly patients should consult a healthcare provider prior to using this product, particularly if they have a history of liver disease. Additionally, it is advisable for geriatric patients to seek guidance from a doctor or pharmacist if they are concurrently taking the anticoagulant warfarin, as interactions may occur.

It is crucial for elderly patients to adhere strictly to the recommended dosage and not exceed it. In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay. Prompt medical attention is essential for adults, including geriatric patients, even if no signs or symptoms of overdose are apparent.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure the safety of both the mother 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 mothers.

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 patients 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 receive appropriate guidance regarding the use of this medication, as compromised liver function may affect the drug's metabolism and overall safety profile. Monitoring of liver function may be necessary to ensure the safe administration of the medication 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 intervention is essential for both adults and children, even in the absence of noticeable signs or symptoms.

Healthcare professionals should be aware that the timely administration of appropriate medical care can significantly influence the outcome of an overdose situation. Therefore, vigilance and swift action are crucial components in the management of potential overdose cases.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to use. Acetaminophen has been associated with severe skin reactions, which may manifest as skin reddening, blisters, or rash.

No specific information regarding nonclinical toxicology or animal pharmacology and toxicology is provided in the insert.

Postmarketing Experience

Postmarketing experience has identified that acetaminophen may be associated with severe skin reactions. Reported symptoms of these reactions 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 product 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 containing acetaminophen, whether prescription or nonprescription. If patients are uncertain whether a medication contains acetaminophen, they should be encouraged to consult a doctor or pharmacist.

Patients should be cautioned against using this product if they have a history of allergic reactions to it or any of its ingredients. They should be instructed to stop using the product and seek medical advice if their pain worsens or persists beyond 10 days for adults or 5 days for children. Additionally, if a fever worsens or lasts more than 3 days, or if new symptoms arise, patients should be advised to discontinue use and consult a healthcare professional.

Healthcare providers should also inform patients to stop using the product and seek medical attention if they notice any redness or swelling, as these may indicate a serious condition. It is crucial to advise against administering this product to children for arthritis pain unless specifically directed by a doctor.

Patients must be reminded not to exceed the recommended dosage, as this could lead to overdose. Furthermore, it is essential to recommend that patients consult a doctor before using this product if they have liver disease. Lastly, patients taking the blood-thinning medication warfarin should be advised to speak with a doctor or pharmacist prior to using this product.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It should be stored at a controlled room temperature of 20-25°C (68-77°F). Care should be taken to ensure that the product is kept in its original container to maintain stability and 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

Patients should use the medication as directed by their healthcare professional, with a recommended repeat dose every 4 hours while symptoms persist, not exceeding 5 doses within a 24-hour period.

Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. It is essential to keep the medication out of reach of children. In the event of an overdose, patients must seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222, as prompt medical attention is crucial for both adults and children, even if no symptoms are apparent.

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)