Averex

Description

Children’s Averex is an oral suspension formulation containing acetaminophen as the active ingredient. It is indicated for the relief of pain and reduction of fever in pediatric patients aged 2 to 11 years. The product is alcohol-free, ibuprofen-free, and aspirin-free, ensuring a safer option for children. Each 5 mL dose delivers a concentration of 160 mg of acetaminophen. The product is presented in a 4 FL OZ (118 mL) volume and features a cherry flavor for palatability. The National Drug Code (NDC) for this formulation is 83314-111-11.

Uses and Indications

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

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Shake the product well before use. Healthcare professionals should determine the appropriate dose based on the patient's weight or, if weight is not available, the patient's age, as outlined in the dosage chart below.

If necessary, the dose may be repeated every 4 hours while symptoms persist. However, it is important 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 lb or under 2 years of age, consult a doctor for dosing recommendations.

• For patients weighing 24-35 lb or aged 2-3 years, administer 5 mL (1 tsp).

• For patients weighing 36-47 lb or aged 4-5 years, administer 7.5 mL (1 1/2 tsp).

• For patients weighing 48-59 lb or aged 6-8 years, administer 10 mL (2 tsp).

• For patients weighing 60-71 lb or aged 9-10 years, administer 12.5 mL (2 1/2 tsp).

• For patients weighing 72-95 lb or aged 11 years, administer 15 mL (3 tsp).

Use only the enclosed dosing cup specifically designed for this product; do not utilize any other dosing device.

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.

• This product should not be administered to children with a known allergy to acetaminophen or any of the inactive ingredients contained in the formulation, as this may lead to severe allergic reactions.

• Exceeding the recommended dosage while using this product is contraindicated, as it poses a risk of overdose.

Warnings and Precautions

Severe liver damage may occur in pediatric patients taking this product, which contains acetaminophen, if they exceed the maximum daily dosage of 5 doses within a 24-hour period or if they concurrently use other medications containing acetaminophen. Healthcare professionals should advise caregivers to adhere strictly to dosing guidelines to mitigate the risk of hepatotoxicity.

Acetaminophen has been associated with severe skin reactions, which may manifest as skin reddening, blisters, or rash. In the event of any skin reaction, it is imperative to discontinue use immediately and seek medical assistance without delay.

In cases of severe sore throat that persists for more than 2 days or is accompanied by additional symptoms such as fever, headache, rash, nausea, or vomiting, prompt consultation with a healthcare provider is recommended to rule out serious underlying conditions.

Healthcare professionals should inquire about the patient's medical history, particularly regarding liver disease, prior to recommending this product. Additionally, it is advisable to consult with a doctor or pharmacist if the child is currently taking warfarin or any other anticoagulant, as potential interactions may necessitate closer monitoring.

If a skin reaction occurs, immediate cessation of the product and urgent medical evaluation are warranted. Furthermore, caregivers should be instructed to contact a healthcare provider if the child experiences worsening pain that lasts beyond 5 days, a fever that persists for more than 3 days, the emergence of new symptoms, or any signs of redness or swelling, as these may indicate a serious medical condition requiring further investigation.

Side Effects

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

Severe liver damage may occur if the maximum daily amount of acetaminophen is exceeded, specifically if more than five doses are taken within a 24-hour period or if the product is used concurrently with other medications containing acetaminophen. In cases of overdose, which may result from taking more than the recommended dose, immediate medical attention is critical. This is essential for both adults and children, even in the absence of noticeable signs or symptoms.

Patients should also be alert to the possibility of severe skin reactions associated with acetaminophen use. Symptoms may include skin reddening, blisters, and rash. If any of these reactions occur, it is imperative to discontinue use and seek medical assistance promptly.

In addition, if a patient experiences a sore throat that is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, they should consult a healthcare provider without delay.

Patients are advised to stop using the product and consult a doctor if pain worsens or lasts longer than five days, if fever worsens or lasts more than three days, if new symptoms arise, or if there is any redness or swelling, as these may indicate a serious condition.

Before using this product, it is recommended that patients consult a doctor if they have a history of liver disease. Furthermore, patients taking the blood-thinning medication warfarin should seek advice from a doctor or pharmacist prior to use.

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 hepatotoxicity. 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 Averex (childrens acetaminophen oral suspension). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 2 years of age should not use this medication without consulting a doctor. For children aged 2 to 11 years, the recommended dosing varies by weight:

• 2 - 3 years (24-35 lbs): 5 mL (1 tsp)

• 4 - 5 years (36-47 lbs): 7.5 mL (1 1/2 tsp)

• 6 - 8 years (48-59 lbs): 10 mL (2 tsp)

• 9 - 10 years (60-71 lbs): 12.5 mL (2 1/2 tsp)

• 11 years (72-95 lbs): 15 mL (3 tsp)

The maximum dosing should not exceed 5 doses in a 24-hour period. Additionally, the duration of use should not exceed 5 days unless directed by a healthcare professional.

Healthcare providers should consult a doctor if the pediatric patient has liver disease or is taking the anticoagulant warfarin. An overdose may lead to liver damage; therefore, immediate medical attention is required if the recommended dose is exceeded.

Geriatric Use

Elderly patients may not have specific information regarding the use of this product, as the prescribing information does not provide guidance on geriatric use. The product is indicated for use in children aged 2 to 11 years, and there are no documented dosage adjustments or safety concerns specifically related to elderly patients.

Healthcare providers should exercise caution when prescribing this product to geriatric patients, given the absence of data on its safety and efficacy in this population. Monitoring for potential adverse effects is advisable, as elderly patients may have different pharmacokinetic and pharmacodynamic responses compared to younger populations.

Pregnancy

The safety of this product during pregnancy has not been established. Pregnant patients or those planning to become pregnant should consult a healthcare provider before use, as there may be potential risks to the fetus; however, specific studies or data regarding these risks are not provided in the prescribing information.

No specific dosage modifications for pregnant individuals are mentioned; therefore, it is essential for healthcare professionals to provide guidance tailored to the individual patient's circumstances. This product should only be used if clearly needed and after a thorough discussion with a healthcare professional regarding the potential risks and benefits.

Lactation

There are no specific warnings or recommendations regarding the use of this product in nursing mothers. Additionally, there is no information available about the potential for excretion in breast milk or any associated risks to breastfed infants.

Renal Impairment

There is no information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution and consider the lack of specific guidance when prescribing to patients with reduced kidney function.

Hepatic Impairment

Patients with hepatic impairment should be closely monitored when using this product, which contains acetaminophen. It is important to note that severe liver damage may occur if patients exceed the maximum daily amount of 5 doses within a 24-hour period. Additionally, caution is advised when this product is used in conjunction with other medications containing acetaminophen, as this may further increase the risk of liver damage.

Healthcare providers should assess liver function prior to initiating treatment and consider dosage adjustments based on the severity of hepatic impairment. Regular monitoring of liver function tests may be warranted to ensure patient safety and to mitigate the risk of adverse effects associated with acetaminophen use in this population.

Overdosage

Taking more than the recommended dose of this medication may lead to significant liver damage. It is imperative that healthcare professionals remain vigilant regarding the potential for overdose and its serious consequences.

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 of overdose.

Monitoring and management of the patient should be initiated as soon as possible to mitigate the risk of severe liver injury and to ensure appropriate care is provided.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the assessment of potential risks associated with the compound in these areas.

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 nonprescription. If patients are uncertain whether a drug contains acetaminophen, they should be encouraged to consult a doctor or pharmacist for clarification.

Patients should be made aware of the potential for allergic reactions. They should be instructed to discontinue use and seek medical advice if their child has a known allergy to acetaminophen or any of the inactive ingredients in the product.

Healthcare providers should emphasize the importance of monitoring symptoms. Patients should be advised to stop use and consult a doctor if pain worsens or persists for more than 5 days, if fever increases or lasts longer than 3 days, if new symptoms develop, or if there is any redness or swelling, as these may indicate a serious condition.

It is crucial to inform patients not to exceed the recommended dosage, as this could lead to overdose. Additionally, patients should be advised to consult a doctor before use if their child has liver disease. If the child is taking the blood-thinning medication warfarin, patients should be instructed to seek guidance from a doctor or pharmacist prior to using this product.

Storage and Handling

The product is supplied in a carton that contains essential information for use. It is important to store the product at a temperature range of 20-25ºC (68-77ºF). Refrigeration is not permitted, as it may compromise the integrity of the product. Users are advised to retain the carton to access the full directions for use.

Additional Clinical Information

The medication is administered orally, with a recommended repeat dose every 4 hours as needed while symptoms persist. Clinicians should advise patients 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.

Patients should be counseled to consult a doctor before use if the child has liver disease or is taking the anticoagulant warfarin. Additionally, it is important to keep the medication out of reach of children. No further information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

Drug Information (PDF)

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

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