Neo-Lubrina

Description

Neo-Lubrina is identified by the National Drug Code (NDC) 69729-118-04.

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 sore throat, the common cold, influenza, headache, 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 should be administered with caution. Prior to use, the product must be shaken well. The appropriate dose should be determined using the dosage chart provided, with preference given to weight-based dosing; if weight is not available, age may be used as a guide.

Dosing intervals are every 4 hours as needed while symptoms persist. Administration should not exceed 5 doses within a 24-hour period. Additionally, treatment should not extend beyond 5 consecutive days unless directed by a healthcare professional.

The enclosed measuring syringe must be used for accurate dosing.

Dosage Chart:

• For patients weighing under 24 lb or under 2 years of age, consult a doctor for the appropriate dose.

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

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

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

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

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

It is essential to consult with a healthcare provider before administering this medication to any infant or child.

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.

Warnings and Precautions

Severe liver damage may occur in children who take more than five doses of this product containing acetaminophen within a 24-hour period, which is the maximum recommended daily amount. Additionally, caution is advised when administering this product alongside other medications that also contain acetaminophen.

In cases of severe sore throat that persists for more than two days, or if it is accompanied by fever, headache, rash, nausea, or vomiting, it is imperative to consult a healthcare professional promptly.

Before use, it is essential to seek medical advice if the child has a history of liver disease. Furthermore, consultation with a doctor or pharmacist is recommended if the child is currently taking the anticoagulant medication warfarin, as interactions may occur.

Healthcare professionals should instruct caregivers to discontinue use and seek medical attention if new symptoms arise, if there is redness or swelling, if pain worsens or lasts longer than five days, or if fever intensifies or persists beyond three days. These symptoms may indicate a serious underlying condition that requires further evaluation.

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, which is more than 5 doses in 24 hours, is exceeded or if the product is taken concurrently with other medications containing acetaminophen. Patients should not use this product in conjunction with any other drug containing acetaminophen, whether prescription or non-prescription, and should consult a healthcare professional if uncertain about the presence of acetaminophen in other medications.

In cases where patients experience a severe sore throat that persists for more than 2 days, or if it is accompanied or followed by fever, headache, rash, nausea, or vomiting, it is advised to seek medical attention promptly.

Patients with a history of liver disease should consult a doctor before using this product. Additionally, those taking the blood-thinning medication warfarin should also seek advice from a healthcare professional prior to use.

An overdose of this product may lead to liver damage. In the event of an overdose, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended. Quick medical attention is critical for both adults and children, even if no signs or symptoms are immediately apparent.

Patients are advised to discontinue use and consult a doctor if new symptoms arise, if redness or swelling occurs, if pain worsens or persists beyond 5 days, or if fever intensifies or lasts more than 3 days, as these may indicate a serious condition.

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 Neo-Lubrina (acetaminophen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients require careful consideration when administering this medication. For children under 2 years of age and weighing less than 24 pounds, it is advised to consult a doctor before use. The recommended dosages for pediatric patients based on weight and age are as follows:

• For children weighing 24-35 pounds (ages 2-3 years): 5 mL

• For children weighing 36-47 pounds (ages 4-5 years): 7.5 mL

• For children weighing 48-59 pounds (ages 6-8 years): 10 mL

• For children weighing 60-71 pounds (ages 9-10 years): 12.5 mL

• For children weighing 72-95 pounds (age 11 years): 15 mL

It is crucial to always check with a healthcare professional before administering medication to infants or children.

Warnings include the risk of severe liver damage if more than 5 doses are taken within a 24-hour period, which is the maximum daily amount. Parents and caregivers should seek medical attention promptly if a child experiences a severe sore throat that persists for more than 2 days or is accompanied by fever, headache, rash, nausea, or vomiting.

In cases of overdose, immediate medical attention is essential for both children and adults, even if no signs or symptoms are apparent.

Geriatric Use

There is no specific information 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. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

The safety of acetaminophen during pregnancy has not been established. The use of this product is contraindicated in pregnancy unless directed by a healthcare provider. There may be potential risks to the fetus; therefore, it is essential for pregnant patients to consult a healthcare provider for advice prior to use. Dosage adjustments may be necessary, and healthcare providers should be consulted to determine the appropriate dosage during pregnancy. Pregnant women are advised to seek medical advice before using this product to ensure the safety and well-being of both the mother and the fetus.

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 specific information regarding renal impairment, dosage adjustments, or monitoring for patients with reduced kidney function provided in the drug insert. Healthcare professionals should exercise caution when prescribing this medication to patients with renal impairment, as the lack of data may necessitate individualized assessment and monitoring based on clinical judgment.

Hepatic Impairment

Patients with hepatic impairment should be closely monitored when using this product, as it contains acetaminophen, which is associated with the risk of severe liver damage. It is critical to adhere to the maximum daily dosage of 5 doses within a 24-hour period to mitigate the risk of hepatotoxicity.

Before administration, it is advised that a healthcare professional be consulted if the patient has a history of liver disease. This precaution is essential to ensure the safe use of the product and to evaluate the potential need for dosage adjustments or additional monitoring based on the severity of the hepatic impairment.

Overdosage

Taking more than the recommended dose of the medication may lead to significant liver damage. In the event of an overdose, it is imperative to seek medical assistance immediately or contact a Poison Control Center. Prompt medical intervention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Healthcare professionals should be vigilant in monitoring for potential symptoms of overdose, which may not always be immediately apparent. The importance of rapid response cannot be overstated, as early treatment can mitigate the risk of severe complications associated with liver injury.

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

No postmarketing experience details are available in the insert text.

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 whether a drug contains acetaminophen, they should be encouraged to consult a doctor or pharmacist for clarification.

Patients should be cautioned against using this medication if their child has a known allergy to acetaminophen or any of the inactive ingredients present in the product. Healthcare providers should instruct patients to discontinue use and seek medical advice if new symptoms arise, or if there is any redness or swelling observed. Additionally, patients should be informed to stop using the medication and consult a doctor if pain worsens or persists for more than five days, or if fever intensifies or lasts longer than three days, as these may indicate a serious underlying condition.

Furthermore, healthcare providers should recommend that patients consult a doctor before using this medication 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 a temperature range of 15° to 30°C (59° to 86°F). Care must be taken to protect the product from freezing, as well as from light exposure to maintain its integrity and efficacy.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients or caregivers to consult a doctor before use if the child has liver disease or is taking the anticoagulant warfarin. Patients should be instructed to discontinue use and seek medical advice if new symptoms arise, if there is redness or swelling, if pain worsens or persists beyond five days, or if fever intensifies or lasts more than three days.

Drug Information (PDF)

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

View product document (PDF)