Acetaminophen Solution

Description

Acetaminophen is presented as an oral solution, conforming to the United States Pharmacopeia (USP) standards. Each 5 mL of the solution contains 160 mg of acetaminophen. This formulation is alcohol-free and is intended for institutional use only.

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

For adults and children aged 12 years and over, the recommended dose is 20.3 mL (equivalent to 650 mg) administered every 4 to 6 hours, with a maximum of 6 doses within a 24-hour period.

For children aged 6 to under 12 years, the appropriate dose is 10.15 mL (325 mg) every 4 hours, not to exceed 5 doses in a 24-hour period.

In children aged 4 to under 6 years, the dosage is 7.5 mL (240 mg) every 4 hours, with a maximum of 5 doses allowed in a 24-hour period.

For children aged 2 to under 4 years, the recommended dose is 5 mL (160 mg) every 4 hours, also not to exceed 5 doses in a 24-hour period.

For children under 2 years of age, it is advised to consult a doctor for appropriate dosing recommendations.

Contraindications

Use of this product is contraindicated in the following situations:

• Co-administration 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.

• Prolonged use for pain exceeding 10 days, unless specifically directed by a healthcare provider, to prevent potential adverse effects associated with extended use.

• Use for fever lasting more than 3 days, unless directed by a healthcare professional, to mitigate the risk of masking underlying conditions.

• Known allergy to acetaminophen or any inactive ingredients in this product, as this may lead to severe allergic reactions.

Warnings and Precautions

This product contains acetaminophen, which poses significant risks if not used according to guidelines. Severe liver damage may occur under the following circumstances: if an adult exceeds 6 doses within a 24-hour period or takes more than 4000 mg of acetaminophen, which is the maximum daily limit; if a child takes more than 5 doses in 24 hours; if it is used concurrently with other medications containing acetaminophen; or if consumed alongside three or more alcoholic beverages daily while using this product.

Acetaminophen may also lead to 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 immediately and seek medical assistance. Additionally, if a sore throat is severe, persists beyond two days, or is accompanied by fever, headache, rash, nausea, or vomiting, prompt consultation with a healthcare provider is advised.

Overdose of acetaminophen can result in liver damage. In such cases, it is crucial to seek medical help or contact a Poison Control Center immediately at 1-800-222-1222. Quick medical attention is essential for both adults and children, even if no signs or symptoms are apparent.

General precautions should be observed. Patients with liver disease should consult a physician prior to use. Furthermore, individuals taking the anticoagulant warfarin should seek advice from a healthcare professional or pharmacist before using this product.

Patients are advised to stop taking the product and consult a doctor if symptoms do not improve, if new symptoms arise, if pain or fever persists or worsens, or if redness or swelling is observed.

Side Effects

Severe liver damage may occur in patients taking this product containing acetaminophen if an adult exceeds 6 doses in 24 hours or takes more than 4000 mg of acetaminophen, the maximum daily amount. For children, taking more than 5 doses in 24 hours poses a similar risk. The likelihood of liver damage increases when this product is used in conjunction with other medications containing acetaminophen or when consumed with three or more alcoholic drinks daily.

Patients may experience severe skin reactions associated with acetaminophen, which can manifest as skin reddening, blisters, or rash. In the event of a skin reaction, it is imperative that patients discontinue use and seek medical assistance immediately.

Sore throat is another potential adverse reaction. If a patient experiences a severe sore throat that persists for more than two days, or if it is accompanied or followed by fever, headache, rash, nausea, or vomiting, they should consult a healthcare professional promptly.

Patients are advised against using this product in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in another medication, patients should consult a doctor or pharmacist. Additionally, this product should not be used for more than 10 days for pain or more than 3 days for fever unless directed by a healthcare provider. Patients with a known allergy to acetaminophen or any inactive ingredients in this product should refrain from its use.

Patients should stop using the product and consult a doctor if symptoms do not improve, if new symptoms arise, or if pain or fever persists or worsens. The presence of redness or swelling should also prompt a consultation with a healthcare professional.

An overdose warning is critical, as taking more than the recommended dose may lead to liver damage. In the event of an overdose, patients should seek medical help or contact a Poison Control Center immediately at 1-800-222-1222. Quick medical attention is essential for both adults and children, even if no signs or symptoms are initially apparent.

Drug Interactions

Patients taking warfarin, a blood-thinning medication, should consult with a healthcare professional prior to using this drug. The interaction between this medication and warfarin may necessitate careful monitoring of coagulation parameters to avoid potential adverse effects. Adjustments to the dosage of either drug may be required based on clinical judgment and patient response.

Packaging & NDC

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

Pediatric Use

Pediatric patients aged 6 to under 12 years may receive a dosage of 10.15 mL (325 mg) every 4 hours, with a maximum of 5 doses in a 24-hour period. For children aged 4 to under 6 years, the recommended dosage is 7.5 mL (240 mg) every 4 hours, also not to exceed 5 doses in a 24-hour period. Children aged 2 to under 4 years should be administered 5 mL (160 mg) every 4 hours, adhering to the same maximum dosing limit.

For children under 2 years of age, it is advised to consult a doctor prior to administration. It is critical to note that exceeding 5 doses within a 24-hour period may result in severe liver damage. Additionally, caregivers should ensure that the medication is kept out of reach of children, as prompt medical attention is essential in cases of overdose, even if no immediate signs or symptoms are present.

Geriatric Use

Elderly patients should consult a healthcare provider prior to use if they have liver disease, as this may impact the safety and efficacy of the treatment.

In the event of an overdose, it is crucial for elderly patients to seek immediate medical attention, regardless of whether they exhibit any signs or symptoms. Prompt intervention is essential to address potential complications associated with overdose in this population.

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 considered in these populations to ensure the safety of both the mother and the fetus or 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 using this product. It is important to note that severe liver damage may occur under certain conditions, including but not limited to:

• Adults exceeding 6 doses within a 24-hour period or taking more than 4000 mg of acetaminophen, which is the maximum daily amount.

• Children taking more than 5 doses in a 24-hour period.

• Concurrent use with other medications containing acetaminophen.

• Consumption of 3 or more alcoholic drinks daily while using this product.

Patients are advised that taking more than the recommended dose may lead to liver damage. In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center without delay. Prompt medical attention is crucial for both adults and children, even if no signs or symptoms of overdose are present.

Overdosage

Taking more than the recommended dose may lead to significant liver damage. It is imperative that healthcare professionals remain vigilant regarding the potential consequences of overdosage.

In the event of an overdose, immediate medical assistance should be sought. Healthcare providers are advised to contact a Poison Control Center without delay; the national hotline can be reached at 1-800-222-1222. Prompt intervention is crucial, as quick medical attention is essential for both adults and children, even in the absence of noticeable signs or symptoms.

Monitoring and management of the patient should be initiated as soon as possible to mitigate the risk of severe complications associated with liver damage.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to use. There are no specific non-teratogenic effects reported. Additionally, no specific nonclinical toxicology details or animal pharmacology and toxicology information have been provided.

Postmarketing Experience

Severe skin reactions have been reported in postmarketing experience with acetaminophen. Symptoms associated with these reactions may include skin reddening, blisters, and rash. In the event of a skin reaction, it is advised to discontinue use immediately and seek medical assistance. Additionally, serious side effects can be reported through the designated contact number.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. Patients should be informed not to use this product in conjunction with any other medications that contain acetaminophen, whether prescription or nonprescription. If patients are uncertain about the presence of acetaminophen in their other medications, they should be encouraged to consult with a doctor or pharmacist.

It is important to instruct patients not to use this medication for more than 10 days for pain or more than 3 days for fever unless directed by a healthcare professional. Patients should be made aware that they should discontinue use and seek medical advice if their symptoms do not improve, if new symptoms arise, or if pain or fever persists or worsens. Additionally, patients should be advised to stop use and consult a doctor if they experience any redness or swelling.

Patients with a known allergy to acetaminophen or any of the inactive ingredients in this product should be cautioned against its use. Furthermore, healthcare providers should recommend that patients with liver disease consult a doctor before using this medication. 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 a configuration that ensures optimal integrity and efficacy. It should be stored at a temperature range of 20° to 25°C (68° to 77°F), in accordance with USP Controlled Room Temperature guidelines.

To maintain the quality of the product, it is essential to keep the container tightly closed and to protect it from light exposure. Additionally, the product should not be used if the foil on the cup is missing or torn, as this may compromise its safety and effectiveness.

Additional Clinical Information

Patients should be advised to consult a health professional if they are pregnant or breastfeeding prior to use. Additionally, it is important for patients with liver disease to seek medical advice before using the product. Those taking the blood-thinning medication warfarin should also consult a doctor or pharmacist before use to ensure safety and avoid potential interactions.

Drug Information (PDF)

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

View product document (PDF)