Acetaminophen

Description

Acetaminophen is an oral solution formulated as 160 mg per 5 mL. It is alcohol-free, dye-free, and sugar-free, with a grape flavor.

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, sore throat, flu, the common cold, toothache, and premenstrual and menstrual cramps. It is also indicated for the relief of minor pain from arthritis and for the 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 older, the recommended dosage is 20 mL (equivalent to 640 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 dosage is 10 mL (320 mg) every 4 hours, not to exceed 5 doses in a 24-hour period.

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

For children aged 2 to under 4 years, the dosage is 5 mL (160 mg) every 4 hours, also limited to 5 doses in a 24-hour period.

For children under 2 years of age, it is advised to consult a doctor before administration.

The product should be administered using the single dose cup provided with the packaging to ensure accurate dosing.

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 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 should not be used in individuals with a known allergy to acetaminophen or any of the inactive ingredients contained in this formulation, as this may lead to severe allergic reactions.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen. Healthcare professionals should advise patients that the risk of liver injury increases under the following circumstances:

• An adult should not exceed 6 doses within a 24-hour period, as this represents the maximum daily amount.

• A child should not take more than 5 doses in a 24-hour period.

• Caution is advised when this product is taken concurrently with other medications containing acetaminophen.

• Adults consuming 3 or more alcoholic beverages daily while using this product are at heightened risk for liver damage.

In addition to liver concerns, healthcare providers should be aware of the potential for severe skin reactions associated with acetaminophen. Symptoms indicative of such reactions may include skin reddening, blisters, and rash. Should any of these symptoms manifest, it is imperative to discontinue use immediately and seek medical assistance.

Healthcare professionals should also be vigilant regarding patients presenting with severe sore throat symptoms. If a sore throat is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, prompt consultation with a physician is recommended.

In the event of any adverse reactions, including skin reactions, patients should be instructed to stop taking the product and contact their healthcare provider without delay.

Side Effects

Severe liver damage may occur in patients who exceed the recommended dosage of this product. Specifically, adults should not take more than 6 doses within a 24-hour period, while children should not exceed 5 doses in the same timeframe. The risk of liver damage is further increased if the product is taken in conjunction with other medications containing acetaminophen or if the adult consumes 3 or more alcoholic drinks daily while using this product.

Patients should be aware of the potential for severe skin reactions associated with acetaminophen. 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.

Additionally, 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.

Overdose of this product can lead to liver damage. Patients are advised to seek medical help or contact a Poison Control Center immediately if they suspect an overdose, even if no signs or symptoms are present. Quick medical attention is critical for both adults and children in such cases.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there are no known interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

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 should consult a doctor before use. For children aged 2 to under 4 years, the recommended dosage is 5 mL (160 mg) every 4 hours, with a maximum of 5 doses in a 24-hour period. Children aged 4 to under 6 years may receive 7.5 mL (240 mg) every 4 hours, also not to exceed 5 doses in a 24-hour period. For those aged 6 to under 12 years, the dosage increases to 10 mL (320 mg) every 4 hours, with the same maximum of 5 doses in a 24-hour period.

In contrast, adults and children 12 years of age and older may take 20 mL (640 mg) every 4 to 6 hours, not exceeding 6 doses in a 24-hour period. Caution is advised regarding liver health; if a child takes more than 5 doses in 24 hours, a liver warning applies. Additionally, it is recommended to consult a doctor if the child is experiencing pain from arthritis. If the child's pain worsens or persists for more than 5 days, use should be discontinued, and a doctor should be consulted.

Geriatric Use

There is no specific information available regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. Monitoring for potential adverse effects and therapeutic efficacy is recommended 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 individuals.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the drug insert text 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 and monitoring of these patients.

Hepatic Impairment

Patients with hepatic impairment should be closely monitored when using this product, which contains acetaminophen. Severe liver damage may occur under certain conditions, particularly in individuals with compromised liver function.

For adults, it is critical to adhere to the maximum daily dosage of 6 doses within a 24-hour period. Exceeding this limit significantly increases the risk of liver damage. In pediatric patients, the maximum is limited to 5 doses in a 24-hour period.

Additionally, patients should be advised against the concurrent use of other medications containing acetaminophen, as this can further elevate the risk of hepatotoxicity.

Patients with a history of alcohol consumption should exercise caution; specifically, those who consume 3 or more alcoholic drinks daily are at an increased risk of liver damage while using this product.

Regular monitoring of liver function is recommended for patients with hepatic impairment to ensure safety and mitigate potential adverse effects.

Overdosage

In the event of an overdose, it is crucial to recognize that exceeding the recommended dosage may lead to significant liver damage. Healthcare professionals should advise patients to seek immediate medical assistance or contact a Poison Control Center without delay. Prompt medical intervention is essential for both adults and children, even in the absence of noticeable signs or symptoms.

Severe liver damage is particularly concerning if an adult consumes more than six doses within a 24-hour period, which represents the maximum allowable daily dosage. It is imperative for healthcare providers to monitor patients closely and initiate appropriate management procedures in cases of suspected overdose to mitigate potential complications.

Nonclinical Toxicology

If pregnant or breast-feeding, it is advised to consult a health professional before use due to potential teratogenic effects.

Acetaminophen has been associated with severe skin reactions, which may manifest as skin reddening, blisters, or rash, indicating non-teratogenic effects that warrant caution.

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

Postmarketing Experience

Postmarketing experience has identified that acetaminophen may be associated with severe skin reactions. Reported symptoms 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. It is important to inform patients that they should not use this product in conjunction with any other medication that contains acetaminophen, whether prescription or nonprescription. If patients are uncertain about whether a drug contains acetaminophen, they should be encouraged to consult with a doctor or pharmacist for clarification.

Patients should be cautioned against using this medication if they have a known allergy to acetaminophen or any of the inactive ingredients present in the product. Additionally, healthcare providers should recommend that patients seek medical advice before using this medication if they have liver disease, as this may affect the safety and efficacy of the treatment.

For pediatric patients, particularly those experiencing pain related to arthritis, it is essential to advise them to consult a doctor prior to use. Furthermore, patients taking the blood-thinning medication warfarin should be instructed to speak with a doctor or pharmacist before using this product to avoid potential interactions.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at a controlled temperature range of 20° to 25°C (68° to 77°F) to maintain its integrity and efficacy. Proper storage conditions must be adhered to, ensuring that the product is kept in a suitable container that protects it from environmental factors. Special handling requirements should be followed to prevent any compromise to 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 further 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)