Pharbetol

Description

PHARBEST is a pain reliever and fever reducer containing acetaminophen as its active ingredient, with each tablet delivering 500 mg of acetaminophen. The product is available in a dosage form of tablets, specifically packaged in a count of 1000 tablets per container. PHARBEST is manufactured in the USA and is formulated as an extra strength product, comparable to the active ingredient found in Extra Strength Tylenol® Caplet. Notably, PHARBEST contains no aspirin. The National Drug Code (NDC) for this product is 73057-376-11.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various conditions, including the common cold, headache, backache, minor pain of arthritis, toothache, muscular aches, and premenstrual and menstrual cramps. 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 instructed to take 2 tablets every 6 hours as needed while symptoms persist. The maximum dosage should not exceed 6 tablets within a 24-hour period, unless otherwise directed by a healthcare professional. Additionally, the use of this medication should not extend beyond 10 days unless specifically advised 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. If there is uncertainty regarding the presence of acetaminophen in another medication, consultation with a healthcare professional is advised.

• This product should not be used in individuals with a known allergy to acetaminophen or any of the inactive ingredients contained in the formulation.

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 significantly if they exceed 4,000 mg of acetaminophen within a 24-hour period, use other medications containing acetaminophen concurrently, or consume three or more alcoholic beverages daily while taking this product.

Patients should be informed of the potential for severe skin reactions associated with acetaminophen. Symptoms indicative of such reactions may include skin reddening, blisters, or rash. In the event of any skin reaction, patients must discontinue use immediately and seek medical assistance.

It is essential for patients to consult a healthcare provider prior to using this product if they have a history of liver disease. Additionally, patients taking the anticoagulant warfarin should seek advice from a doctor or pharmacist before use, as interactions may occur.

In cases of overdose, immediate medical attention is critical. Patients should be instructed to contact a Poison Control Center or seek emergency medical help without delay (1-800-222-1222).

Patients should also be advised to discontinue use and consult a healthcare professional if any of the following occur: worsening pain or pain lasting more than 10 days, worsening fever or fever lasting more than 3 days, presence of redness or swelling, or the emergence of new symptoms. These signs may indicate a serious underlying condition that requires further evaluation.

Side Effects

Severe liver damage may occur in patients taking this product containing acetaminophen if they exceed 4,000 mg in 24 hours, use it in conjunction with other drugs containing acetaminophen, or consume three or more alcoholic drinks daily while using this product. Patients should be aware of the potential for severe skin reactions associated with acetaminophen, which may manifest as skin reddening, blisters, or rash. In the event of a skin reaction, patients are advised to discontinue use and seek medical assistance immediately.

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

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

In the case of an overdose, patients should seek medical help or contact a Poison Control Center immediately at 1-800-222-1222.

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 Pharbetol (acetaminophen 500mg). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Children under 12 years of age should consult a healthcare professional before use. For adolescents aged 12 years and older, the recommended dosage is 2 tablets every 6 hours as needed for symptom relief, with a maximum of 6 tablets in a 24-hour period unless otherwise directed by a physician. Additionally, use should not exceed 10 days unless advised by a healthcare provider.

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.

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 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, as it contains acetaminophen, which is associated with the risk of severe liver damage. It is critical that patients do not exceed a maximum dosage of 4,000 mg of acetaminophen within a 24-hour period. Additionally, patients should avoid concurrent use with other medications that contain acetaminophen, as this may further increase the risk of liver injury.

Patients with compromised liver function are advised to consult a healthcare professional prior to using this product, particularly if they have a history of liver disease. Furthermore, consumption of three or more alcoholic drinks per day while using this product is strongly discouraged, as it may exacerbate the risk of liver damage. Regular monitoring of liver function may be warranted in patients with existing liver conditions to ensure safety and efficacy during treatment.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222. Prompt action is crucial to mitigate potential health risks associated with excessive intake.

Healthcare professionals should be aware that symptoms of overdose may vary depending on the substance involved. Monitoring the patient closely for any signs of adverse reactions is essential.

Management of an overdose typically involves supportive care and symptomatic treatment. The specific approach may depend on the nature of the overdose and the patient's clinical status. It is advisable to follow established protocols and guidelines for the management of overdose cases to ensure optimal patient outcomes.

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. Further studies may be necessary to elucidate these aspects of nonclinical toxicology.

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 seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 in the event of an overdose. It is crucial to inform patients that they should not use this medication in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription. If patients are uncertain about the presence of acetaminophen in their other medications, they should be encouraged to consult with a doctor or pharmacist.

Patients must be cautioned against using this product if they have a known allergy to acetaminophen or any of the inactive ingredients contained within. Healthcare providers should instruct patients to discontinue use and consult a doctor if their pain worsens or persists for more than 10 days, if their fever intensifies or lasts longer than 3 days, if they notice any redness or swelling, or if they experience new symptoms that may indicate a serious condition.

Additionally, it is important for healthcare providers to recommend that patients seek medical advice before using this medication if they have liver disease. Patients taking the blood-thinning medication warfarin should also be advised to consult with a doctor or pharmacist prior to use.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It is essential to store the product at a controlled temperature range of 20-25°C (68-77°F) to maintain its integrity and efficacy. Proper storage conditions must be adhered to, ensuring that the product is kept in a suitable container to prevent exposure to extreme temperatures or environmental conditions. Special handling requirements should be followed to ensure the product remains within the specified temperature range throughout its storage period.

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 Pharbetol, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)