Pain Reliever Fever Reducer

Description

Acetaminophen is a liquid formulation containing 500 mg of the active ingredient per dosage. It serves as a pain reliever and fever reducer, indicated for use in individuals aged 12 years and older. The product is flavored with cherry to enhance palatability. It is packaged with a tamper-evident safety seal; the product should not be used if the seal is broken or missing.

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 ache, 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 30 mL every 6 hours as needed while symptoms persist. It is imperative not to exceed 4 doses within a 24-hour period and to limit the duration of use to a maximum of 10 days unless otherwise directed by a healthcare professional.

For accurate dosing, the provided dosing cup must be used; no other dosing devices should be employed. The dosing cup should be kept with the product to ensure proper measurement.

Children under 12 years of age should not use this medication. It is essential to adhere strictly to these guidelines to avoid the risk of overdose.

Contraindications

Use of this product is contraindicated in patients who are concurrently taking any other medication that contains acetaminophen, whether prescription or nonprescription. This is due to the potential risk of acetaminophen overdose, which can lead to severe liver damage. If there is uncertainty regarding the presence of acetaminophen in other medications, consultation with a healthcare professional is advised.

Warnings and Precautions

This product contains acetaminophen, which carries specific warnings and precautions that healthcare professionals must communicate to patients for safe use.

Liver Warning The maximum daily dose of this product is 90 mL (6 tablespoons), equating to 3,000 mg of acetaminophen within a 24-hour period. Severe liver damage may occur if the patient exceeds 4,000 mg of acetaminophen in 24 hours, uses this product in conjunction with other medications containing acetaminophen, or consumes three or more alcoholic drinks daily while using this product.

Allergy Alert Acetaminophen may lead to severe skin reactions. Symptoms indicative of such reactions include skin reddening, blisters, and rash. Should any of these symptoms manifest, the patient must discontinue use immediately and seek medical assistance.

General Precautions Patients should be advised to consult a healthcare provider prior to use if they have a history of liver disease. Additionally, it is essential to inquire about the concurrent use of the blood-thinning medication warfarin, as interactions may occur.

Emergency Medical Help In the event of an overdose, it is critical to seek immediate medical attention or contact a Poison Control Center at 1-800-222-1222. Prompt medical intervention is vital for both adults and children, even if no signs or symptoms are initially apparent.

Monitoring and Follow-Up Patients should be instructed to stop taking the product and contact their healthcare provider if any of the following occur: worsening pain lasting more than 10 days, fever persisting for more than 3 days, the emergence of new symptoms, or the presence of redness or swelling. These signs may indicate a serious underlying condition that requires further evaluation.

Side Effects

Patients using this product should be aware of several important warnings and potential adverse reactions.

Severe liver damage may occur if the maximum daily dose of 90 mL (6 tablespoons) or 3,000 mg of acetaminophen is exceeded within a 24-hour period. Specifically, patients should avoid taking more than 4,000 mg of acetaminophen in 24 hours, using other medications that contain acetaminophen concurrently, or consuming 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. If any of these symptoms occur, patients are advised to discontinue use immediately and seek medical assistance.

Patients should stop using the product and consult a healthcare professional if pain worsens or persists for more than 10 days, if fever intensifies or lasts longer than 3 days, if new symptoms arise, or if redness or swelling is observed, as these may indicate a serious condition.

It is recommended that patients with liver disease consult a doctor before using this product. Furthermore, individuals taking the blood-thinning medication warfarin should seek advice from a healthcare provider or pharmacist prior to use.

An overdose warning is also pertinent; taking more than the recommended dose can lead to liver damage. In the event of an overdose, it is crucial to seek medical help or contact a Poison Control Center (1-800-222-1222) immediately, as prompt medical attention is essential for both adults and children, even if no signs or symptoms are initially apparent.

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. Patients are advised to verify the presence of acetaminophen in other medications by consulting a healthcare provider or pharmacist to avoid unintentional overdose.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 12 years of age should not use this medication. For adolescents aged 12 years and older, the recommended dosage is 30 mL every 6 hours while symptoms persist, with a maximum duration of use not exceeding 10 days unless directed by a healthcare professional.

Healthcare providers should be aware of the critical need for quick medical attention in cases of overdose, applicable to both adults and children, even in the absence of noticeable signs or symptoms. It is essential to keep this medication out of reach of children to prevent accidental ingestion.

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 potential 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 considered in these populations to ensure the safety of both the mother and the fetus or infant.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data on 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 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 patients with reduced kidney function, as the absence of detailed guidance 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 be closely monitored when using this product, which contains acetaminophen. It is essential to note that the maximum daily dose of this product is 90 mL (6 tablespoons), equating to 3,000 mg of acetaminophen within a 24-hour period. Patients must be cautioned against exceeding 4,000 mg of acetaminophen in 24 hours, as this may lead to severe liver damage.

Additionally, patients should avoid concurrent use of other medications containing acetaminophen and limit alcohol consumption to fewer than three drinks per day while using this product, as these factors can further increase the risk of liver injury.

Patients with a history of liver disease are advised to consult a healthcare professional prior to using this product. In the event of an overdose, which may occur if the recommended dose is exceeded, immediate medical assistance should be sought, or the Poison Control Center (1-800-222-1222) should be contacted. Prompt medical attention is critical for both adults and children, even in the absence of noticeable signs or symptoms of overdose.

Overdosage

Taking more than the recommended dose of this medication may lead to significant liver damage. It is crucial for healthcare professionals to recognize the seriousness of an overdose and the potential for severe health consequences.

In the event of an overdose, immediate medical assistance should be sought. Healthcare providers are advised to contact a Poison Control Center at 1-800-222-1222 without delay. Prompt intervention is essential, as quick medical attention can be critical for both adults and children, even in the absence of noticeable signs or symptoms of overdose.

Monitoring and management of the patient should be initiated as soon as possible to mitigate the risks associated with liver damage and to ensure appropriate care is provided.

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 understanding of potential risks associated with the compound in nonclinical settings.

Postmarketing Experience

Acetaminophen has been associated with severe skin reactions in postmarketing experience. Reports indicate that symptoms may 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 about the potential risks associated with overdose, emphasizing that taking more than the recommended dose may lead to liver damage. In the event of an overdose, patients should seek medical help immediately or contact a Poison Control Center at 1-800-222-1222, as prompt medical attention is crucial for both adults and children, even if no signs or symptoms are apparent.

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 whether a medication contains acetaminophen, they should be encouraged to consult with a doctor or pharmacist for clarification.

It is important for patients to stop using the medication and consult a doctor if their pain worsens or persists for more than 10 days. Similarly, they should seek medical advice if their fever worsens or lasts longer than 3 days, 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 advised to consult a doctor before using this medication. Additionally, those taking the blood-thinning medication warfarin should also be encouraged 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 various package configurations, with specific NDC numbers available for identification. It is essential to store the product at a temperature range of 20-25ºC (68-77ºF) and to avoid refrigeration. Additionally, the product must be protected from light to maintain its integrity and efficacy. Proper handling and storage conditions are crucial to ensure the product's quality throughout its shelf life.

Additional Clinical Information

The medication is administered orally, with a recommended dosage of 30 mL every 6 hours for adults and children aged 12 years and older, while symptoms persist. Patients should not exceed 10 days of use unless directed by a healthcare professional.

Clinicians should counsel patients to consult a health professional if they are pregnant or breastfeeding. It is essential to keep the medication out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center (1-800-222-1222) should be contacted, as prompt attention is crucial for both adults and children, even in the absence of symptoms.

Drug Information (PDF)

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

View product document (PDF)