Pharbetol

Description

No description information is available for the specified drug.

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, the use of this medication should not extend beyond 10 days unless specifically instructed by a doctor.

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 the duration of use should not exceed 5 days unless directed by a healthcare provider.

For children under 6 years of age, it is recommended to consult a doctor before administration.

Contraindications

Use of this product is contraindicated in the following situations:

Patients should not use this product in conjunction with any other medication containing acetaminophen, whether prescription or nonprescription, 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 is contraindicated in individuals with a known allergy to acetaminophen or any of the inactive ingredients contained in the 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 allowable amount.

• 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 use. Patients with liver disease should consult a physician before using this product. Additionally, individuals taking the anticoagulant warfarin should seek advice from a healthcare provider or pharmacist before use.

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 also 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.

• New symptoms develop.

• Redness or swelling is observed.

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

Side Effects

Severe liver damage may occur in patients who exceed the recommended dosage of acetaminophen. Specifically, adults should not take more than 4,000 mg in a 24-hour period, while children should not exceed 5 doses within the same timeframe, which constitutes the maximum daily amount. The risk of liver damage is further heightened if acetaminophen is taken in conjunction with other medications containing acetaminophen or if an adult consumes three or more alcoholic drinks daily while using this product.

Patients should be aware of the potential for severe skin reactions associated with acetaminophen use. Symptoms indicative of such reactions may include skin reddening, blisters, and rash. Individuals with a known allergy to acetaminophen or any of the inactive ingredients in the product should refrain from its use.

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

Patients are instructed to discontinue use and consult a healthcare provider if any of the following occur: pain worsens or persists for more than 10 days in adults, pain lasts more than 5 days in children under 12 years, fever worsens or lasts more than 3 days, new symptoms arise, or if redness or swelling is observed. These symptoms may indicate a serious underlying condition that requires medical attention.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there are no known interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

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

Pediatric Use

Pediatric patients may use this medication with specific dosing considerations. The maximum daily dose for children is 5 tablets (1,625 mg) within a 24-hour period. For children under 6 years of age, it is advised to consult a doctor before use.

Children aged 6 to under 12 years should not exceed 5 tablets in 24 hours. Additionally, children under 12 years should not take more than 10 tablets in 24 hours unless directed by a healthcare professional.

It is important to note that the medication should not be used for more than 5 days in children under 12 years unless directed by a doctor. If pain worsens or persists for more than 5 days, or if fever worsens or lasts more than 3 days, a consultation with a healthcare provider is recommended.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any adverse effects or changes in therapeutic response, 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. 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 not been specifically addressed in the drug insert regarding dosage adjustments, special monitoring, or safety considerations. 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, although specific recommendations are not provided.

Hepatic Impairment

Patients with hepatic impairment should consult a healthcare professional prior to using this product. It is important to note that severe liver damage may occur if an adult exceeds a dosage of 4,000 mg of acetaminophen within a 24-hour period. Additionally, patients with compromised liver function who consume three or more alcoholic drinks daily while using this product are at an increased risk for severe liver damage. Therefore, careful consideration and monitoring of liver function are advised in this population to prevent potential adverse effects.

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 overdosage.

Potential Symptoms and Risks One of the significant risks associated with acetaminophen overdose is severe liver damage. This risk is particularly pronounced in adults who consume more than 4,000 mg of acetaminophen within a 24-hour period. Healthcare professionals should be vigilant in monitoring for signs of liver impairment in patients presenting with overdose symptoms.

Management Procedures Upon recognition of an overdose, healthcare providers should initiate appropriate management protocols. This may include supportive care and the administration of N-acetylcysteine (NAC) as an antidote, depending on the timing and severity of the overdose. Continuous assessment of liver function and overall patient status is essential in guiding further treatment decisions.

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 these contexts.

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 and seek medical assistance immediately.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of the 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 nonprescription. If patients are uncertain about the presence of acetaminophen in other 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 in the formulation. Healthcare providers should instruct patients to discontinue use and seek medical advice if their pain worsens or persists for more than 10 days in adults, or for more than 5 days in children under 12 years of age. Additionally, patients should be advised to stop use and consult a doctor if their fever worsens or lasts more than 3 days, if new symptoms arise, or if they notice any redness or swelling, as these may indicate a serious condition.

It is also essential 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 seek guidance from a doctor or pharmacist prior to using this product.

Storage and Handling

The product is supplied in a configuration that ensures tamper evidence; it should not be used if the imprinted safety seal under the cap is broken or missing.

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