Pharbetol

Description

PHARBEST is a pain reliever and fever reducer containing acetaminophen as its active ingredient, with each tablet delivering 325 mg of acetaminophen. This product is manufactured in the USA and is available in a dosage form of tablets, with a total of 1000 tablets per package. PHARBEST is formulated without aspirin and is comparable to the active ingredient found in TYLENOL® Regular Strength. The National Drug Code (NDC) for this product is 73057-353-11.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with 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 older are advised to take 2 tablets every 4 to 6 hours as needed while symptoms persist. The maximum dosage should not exceed 10 tablets 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 without medical supervision.

For children aged 6 to under 12 years, the recommended dosage is 1 tablet every 4 to 6 hours while symptoms last. The total daily intake should not surpass 5 tablets, and use should be limited to a maximum of 5 days unless directed by a physician.

For children under 6 years of age, it is recommended to consult a healthcare provider 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 contained in this formulation, as this may lead to severe allergic reactions.

Warnings and Precautions

This product contains acetaminophen, which poses significant risks if not used according to the specified guidelines. The maximum daily dosage for adults is limited to 10 tablets (3,250 mg) within a 24-hour period, while for children, the maximum is 5 tablets (1,625 mg) in the same timeframe. Severe liver damage may occur under the following circumstances:

• An adult consumes more than 4,000 mg of acetaminophen in 24 hours.

• A child exceeds 5 doses in 24 hours, which is the maximum daily allowance.

• The product is taken concurrently with other medications containing acetaminophen.

• An adult consumes 3 or more alcoholic beverages daily while using this product.

Healthcare professionals should be vigilant regarding potential allergic reactions associated with acetaminophen. Severe skin reactions may manifest as skin reddening, blisters, or rash. Should any of these symptoms occur, it is imperative to discontinue use immediately and seek medical assistance.

General precautions should be observed prior to administration. Patients with liver disease should consult a physician before use. Additionally, individuals taking the anticoagulant warfarin should seek advice from a healthcare provider or pharmacist before using this product.

In the event of an overdose, immediate medical attention is required. Patients or caregivers should contact a Poison Control Center at 1-800-222-1222 without delay.

Patients should be advised to discontinue use and consult a physician if any of the following occur:

• Pain worsens or persists for more than 10 days in adults.

• Pain worsens or lasts more than 5 days in children under 12 years.

• Fever worsens or lasts more than 3 days.

• Redness or swelling is observed.

• New symptoms develop.

These signs may indicate a serious underlying condition that necessitates further evaluation.

Side Effects

Patients using this product should be aware of the potential for serious adverse reactions, particularly related to liver health and allergic responses.

Severe liver damage may occur if adults exceed a maximum daily dose of 4,000 mg of acetaminophen or if children take more than the recommended maximum of 5 doses (1,625 mg) in 24 hours. The risk of liver damage is further increased if the product is taken in conjunction with other medications containing acetaminophen or if the adult consumes three or more alcoholic drinks daily while using this product.

Additionally, acetaminophen may cause severe skin reactions, which can manifest as skin reddening, blisters, or rash. In the event of any skin reaction, patients are advised to discontinue use immediately and seek medical assistance.

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

Patients are instructed to stop using the product and consult a healthcare provider if pain worsens or persists beyond 10 days in adults or 5 days in children under 12 years, 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, immediate medical attention should be sought, or the Poison Control Center should be contacted at 1-800-222-1222.

Drug Interactions

Patients taking the anticoagulant warfarin should consult a healthcare professional prior to initiating treatment with this medication. The interaction between this drug and warfarin may necessitate careful monitoring of coagulation parameters to avoid potential adverse effects related to increased bleeding risk. Adjustments to the dosage of warfarin may be required based on the clinical judgment of the healthcare provider.

Packaging & NDC

Below are the non-prescription pack sizes of Pharbetol (acetaminophen 325 mg). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 6 to under 12 years may take 1 tablet every 4 to 6 hours as needed for symptom relief, with a maximum of 5 tablets (1,625 mg) in a 24-hour period. Treatment should not exceed 5 consecutive days unless directed by a healthcare professional.

For children under 6 years, it is advised to consult a doctor before use.

It is important to note that exceeding the maximum daily dose of 5 tablets can lead to severe liver damage. Therefore, careful adherence to dosing guidelines is essential to ensure safety in pediatric patients.

Geriatric Use

There is no specific information available 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

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, as well as any available data regarding fetal outcomes and lactation. Healthcare providers can offer guidance tailored to individual circumstances, ensuring the safety of both the patient and the developing fetus or nursing infant.

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 drug 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.

Hepatic Impairment

Patients with hepatic impairment should exercise caution when using this product, which contains acetaminophen. It is advised that individuals with liver disease consult a healthcare professional prior to use. The maximum daily dose for adults is limited to 10 tablets (3,250 mg) within a 24-hour period, while for children, the maximum is 5 tablets (1,625 mg) in the same timeframe.

Severe liver damage may occur if the following conditions are met: an adult consumes more than 4,000 mg of acetaminophen in 24 hours, a child exceeds 5 doses in 24 hours, the product is taken concurrently with other medications containing acetaminophen, or an adult consumes 3 or more alcoholic drinks daily while using this product.

Due to the potential for increased risk of liver toxicity, careful monitoring of liver function is recommended for patients with compromised liver function.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. The national Poison Control Center can be reached at 1-800-222-1222.

Healthcare professionals should be aware that prompt intervention is crucial in managing overdose situations. Symptoms of overdose may vary depending on the substance involved, and it is essential to monitor the patient closely for any signs of adverse reactions.

Management of an overdose typically involves supportive care and symptomatic treatment. Healthcare providers should assess the patient's condition, including vital signs and level of consciousness, and initiate appropriate interventions based on the clinical presentation.

In summary, timely medical intervention and appropriate management strategies are vital in addressing overdose cases effectively.

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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

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 not to use this medication in conjunction with any other drug that contains acetaminophen, whether prescription or nonprescription. If patients are uncertain about the presence of acetaminophen in their medications, they should be encouraged to consult with a doctor or pharmacist.

Patients should 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 in adults, or for more than 5 days in children under 12 years. Additionally, patients should be advised to stop use and seek medical advice if fever worsens or lasts more than 3 days, if there is any redness or swelling, or if new symptoms arise, as these may indicate a serious condition.

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

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. 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 should be ensured to prevent exposure to extreme temperatures or environmental factors that may compromise the product's quality.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients who are pregnant or breastfeeding to consult a healthcare 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)