Fortolin

Description

Fortolin is a pain reliever and fever reducer formulated without aspirin, minimizing the risk of gastric irritation. Each tablet contains 500 mg of acetaminophen. The product is packaged in a bottle containing 24 tablets, which are individually sealed in foil unit dose pouches to ensure safety and integrity. The National Drug Code (NDC) for Fortolin is 51467-127-24. It is imperative not to use the product if any of the individual pouches are torn, broken, or show evidence of having been opened.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with the common cold, headache, toothache, and muscular aches. Additionally, it is utilized to reduce fever.

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

Dosage and Administration

Patients are advised to take 1 tablet every 3 to 4 hours or 2 tablets every 6 hours, as needed, while symptoms persist. The maximum recommended dosage is 8 tablets within a 24-hour period, unless otherwise directed by a healthcare professional.

For children under 12 years of age, it is essential to consult a doctor prior to administration.

Contraindications

Use is contraindicated in children under 3 years of age due to safety concerns associated with this age group. No other contraindications have been specified in the provided data.

Warnings and Precautions

Patients should be advised regarding the potential risks associated with the use of acetaminophen, particularly concerning alcohol consumption and liver health. It is crucial to inform patients that consuming three or more alcoholic drinks daily may necessitate a discussion with a healthcare provider about the appropriateness of using acetaminophen or other pain relievers and fever reducers, as this combination can increase the risk of liver damage.

General precautions must be emphasized to ensure safe use. Acetaminophen should be stored out of reach of children. 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 both adults and children, even if no signs or symptoms are initially apparent.

Patients should be instructed to discontinue use and consult a healthcare professional if they find it necessary to use this product for pain relief for more than 10 days. Additionally, if fever persists for more than 72 hours or worsens, or if new symptoms arise, medical advice should be sought. The presence of redness or swelling should also prompt immediate consultation, as these may indicate a serious underlying condition.

Side Effects

Patients should be aware of the potential adverse reactions associated with the use of this product. Serious adverse reactions may occur, and it is crucial to monitor for specific symptoms. Patients are advised to stop use and consult a healthcare professional if they require pain relief for more than 10 days, if fever persists for more than 3 days (72 hours) or worsens, if new symptoms arise, or if there is any redness or swelling, as these may indicate a serious condition.

Additionally, there is a warning regarding alcohol consumption. Patients who consume three or more alcoholic drinks daily should consult their doctor before taking acetaminophen or other pain relievers/fever reducers, as acetaminophen may pose a risk of liver damage in such cases.

Drug Interactions

Consumption of three or more alcoholic drinks daily may increase the risk of liver damage when taking acetaminophen. Patients are advised to consult their healthcare provider regarding the use of acetaminophen or other pain relievers and fever reducers under these circumstances.

No specific interactions with laboratory tests have been identified in the available data.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 3 years of age should not be administered this medication. For children aged 3 to 11 years, it is recommended to consult a healthcare professional prior to use to ensure safety and appropriate dosing.

Geriatric Use

There is no specific information regarding the use of FORTOLIN (acetaminophen tablet) in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as they may have altered pharmacokinetics and increased sensitivity to medications. Monitoring for efficacy and adverse effects is recommended in this population, given the lack of targeted data.

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 safe use during pregnancy and lactation.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is no specific data available regarding the excretion of this medication in 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 available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

Hepatic Impairment

Patients with hepatic impairment may be at an increased risk of liver damage when using acetaminophen. It is essential to monitor liver function closely in this population. Due to the potential for exacerbated hepatic effects, dosage adjustments may be necessary for patients with compromised liver function. Healthcare providers should evaluate the patient's liver status and consider alternative analgesics or lower doses of acetaminophen, ensuring that the total daily dose does not exceed the recommended limits. Regular assessment of liver enzymes and overall liver function is advised to mitigate the risk of hepatotoxicity in these patients.

Overdosage

In the context of overdosage, it is important to note that no specific information regarding overdosage is provided in the available sections of the Structured Product Labeling (SPL).

Healthcare professionals are advised to exercise caution and consider the potential implications of an overdose, even in the absence of detailed guidance. In cases of suspected overdosage, it is recommended that healthcare providers monitor the patient closely for any adverse effects and manage symptoms as they arise.

Should an overdosage occur, supportive care and symptomatic treatment should be initiated as necessary. It is essential to consult local poison control centers or relevant medical authorities for further guidance on management strategies tailored to the specific circumstances of the overdose.

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 use of the compound in question.

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. In the event of an overdose, patients should seek medical help or contact a Poison Control Center immediately.

It is important for healthcare providers to emphasize the necessity of prompt medical attention for both adults and children, even if no signs or symptoms are initially apparent. Providers should inform patients that this product is not recommended for use in children under 3 years of age.

Patients should be instructed to discontinue use and consult a doctor if they find it necessary to use the product for pain for more than 10 days. Additionally, they should be advised to stop use and seek medical advice if a fever persists for more than 3 days (72 hours) or worsens.

Healthcare providers should also counsel patients to stop using the product and consult a doctor if new symptoms arise, or if there is any redness or swelling, as these may indicate a serious condition.

Storage and Handling

The product is supplied in its original packaging, which must be kept tightly closed to maintain integrity. It should be stored away from direct sunlight to prevent degradation. Proper storage conditions are essential to ensure the product's efficacy and safety.

Additional Clinical Information

The medication is administered orally, with a recommended dosage of 1 tablet every 3 to 4 hours or 2 tablets every 6 hours while symptoms persist. Patients should not exceed 8 tablets in a 24-hour period unless directed otherwise by a healthcare professional.

There is no additional information available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

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

View product document (PDF)