Notts - Extra Strength 500 mg

Description

NOTTS™ Extra Strength is a formulation containing acetaminophen, serving as a pain reliever and fever reducer. Each caplet contains 500 mg of acetaminophen. The product is packaged in a bottle containing 24 caplets. This formulation is comparable to the active ingredients found in Tylenol® Extra Strength. The National Drug Code (NDC) for this product is 82706-007-01.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various conditions, including common cold, headache, toothache, muscular aches, backaches, premenstrual and menstrual cramps, and minor pain from arthritis. Additionally, it is indicated for the temporary reduction of fever.

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

Dosage and Administration

Adults and children aged 12 years and over are advised to take 2 caplets every 6 hours as needed. The maximum dosage should not exceed 8 caplets within a 24-hour period, unless otherwise directed by a healthcare professional. Additionally, this medication should not be used for more than 10 consecutive days unless specifically instructed by a doctor.

For children under 12 years of age, it is recommended to consult a healthcare professional for appropriate dosing guidance.

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, as this may lead to severe allergic reactions.

Warnings and Precautions

This product contains acetaminophen, which poses a risk of severe liver damage if the following conditions are met: exceeding 4,000 mg of acetaminophen within a 24-hour period, using other medications that also contain acetaminophen, or consuming three or more alcoholic beverages daily while using this product.

Acetaminophen may also lead to severe skin reactions, which can manifest as skin reddening, rash, or blisters. In the event of a skin reaction, it is imperative to discontinue use immediately and seek medical attention.

Healthcare professionals should advise patients to consult a doctor prior to use if they have a history of liver disease. Additionally, patients taking the anticoagulant warfarin should seek guidance from a doctor or pharmacist before using this product.

In cases of overdose, it is crucial to obtain emergency 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.

Patients should be instructed to stop using this product and contact their healthcare provider if any of the following occur: pain persists for more than 10 days, fever lasts longer than 3 days, pain or fever worsens, new symptoms arise, or if there is any redness or swelling. These symptoms may indicate a serious underlying condition that requires further evaluation.

Side Effects

Severe liver damage may occur in patients who exceed the maximum daily dosage of 4,000 mg of acetaminophen within a 24-hour period, take acetaminophen in conjunction with other medications containing acetaminophen, or consume three or more alcoholic drinks daily while using this product.

Patients should be aware that acetaminophen may cause severe skin reactions, which can manifest as skin reddening, rash, or blisters. In the event of a skin reaction, it is imperative to discontinue use and seek medical attention immediately.

This product should not be used in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription. Patients who are allergic to acetaminophen or any of the inactive ingredients should also refrain from using this product.

Prior to use, patients with liver disease should consult a doctor. Additionally, individuals taking the blood-thinning medication warfarin are advised to seek guidance from a doctor or pharmacist before using this product.

Patients are instructed to stop use and consult a doctor if pain persists for more than 10 days, fever lasts more than 3 days, pain or fever worsens, new symptoms arise, or if redness or swelling is observed, as these may indicate a serious condition.

In cases of overdose, it is crucial to avoid exceeding the recommended dosage. Patients should seek medical help or contact a Poison Control Center immediately, as prompt medical attention is essential for both adults and children, even if no signs or symptoms are present.

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, patients are advised to seek guidance from a healthcare provider.

Packaging & NDC

Below are the non-prescription pack sizes of Notts - Extra Strength 500 mg (acetaminophen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional before use. For adolescents aged 12 years and older, the recommended dosage is 2 caplets every 6 hours, with a maximum of 8 caplets in a 24-hour period, unless otherwise directed by a healthcare provider. It is advised that this medication not be used for more than 10 days unless specifically instructed by a doctor.

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. Monitoring for potential adverse effects and therapeutic efficacy 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. It is important to assess the potential risks and benefits associated with its use during pregnancy and lactation. The safety of this medication in pregnant women has not been established, and caution is advised to ensure the well-being of both the mother and the fetus.

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 no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data 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 exercise caution when using this product, which contains acetaminophen. Severe liver damage may occur if patients exceed the maximum daily dosage of 4,000 mg of acetaminophen within a 24-hour period. Additionally, patients should avoid concomitant use with other medications that contain acetaminophen, as this may further increase the risk of liver injury.

It is also advised that patients with compromised liver function refrain from consuming three or more alcoholic drinks daily while using this product, as this can exacerbate the potential for liver damage.

Before initiating treatment, patients with a history of liver disease should consult a healthcare professional to assess the appropriateness of this product for their condition. Regular monitoring of liver function may be warranted in these patients to ensure safety and mitigate the risk of adverse effects.

Overdosage

In the event of an overdose, it is imperative that individuals do not exceed the recommended dosage. Should an overdose occur, immediate medical assistance should be sought, or the local Poison Control Center should be contacted.

Prompt medical attention is crucial for both adults and children, even in the absence of noticeable signs or symptoms. Healthcare professionals are advised to monitor the patient closely and provide appropriate interventions based on the clinical presentation.

Nonclinical Toxicology

If pregnant or breast-feeding, it is advised to consult a health professional before use. No specific non-teratogenic effects have been identified in the available data. Additionally, there are no detailed findings regarding nonclinical toxicology or animal pharmacology and toxicology provided in the current information.

Postmarketing Experience

Postmarketing experience has identified that acetaminophen may be associated with severe skin reactions. Reported symptoms include skin reddening, rash, and blisters. In the event of a skin reaction, it is advised to discontinue use and seek medical attention immediately.

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 medication in conjunction with any other drug that contains acetaminophen, whether prescription or nonprescription. If patients are uncertain about whether a drug contains acetaminophen, they should be encouraged to consult a doctor or pharmacist for clarification.

It is essential to inform patients that they should not use this medication if they have a known allergy to acetaminophen or any of the inactive ingredients present in the formulation. Patients should be instructed to stop using the medication and seek medical advice if their pain persists for more than 10 days or if their fever lasts longer than 3 days. Additionally, they should be advised to discontinue use and consult a doctor if their pain or fever worsens, if new symptoms arise, or if they notice any redness or swelling, as these may indicate a serious condition.

Patients with a history of liver disease should be encouraged to consult a doctor before using this medication. Furthermore, those taking the blood-thinning medication warfarin should be advised to speak with a doctor or pharmacist prior to use to ensure safety and avoid potential interactions.

Storage and Handling

The product is supplied in a tamper-evident packaging format. It is essential to inspect the carton and bottle cap prior to use; do not use the product if the carton is open or if the foil inner seal is broken or missing.

For optimal storage, the product should be maintained at a temperature range of 20-25°C (68-77°F). Proper handling and storage conditions are crucial to ensure the integrity and safety of the product.

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 experience.

Drug Information (PDF)

This file contains official product information for Notts - Extra Strength 500 mg, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)