Pain Reliever

Description

No description information is available for the drug.

Uses and Indications

This drug is indicated for the temporary reduction of fever and the temporary relief of minor aches and pains associated with conditions such as the common cold, influenza, headache, sore throat, and toothache.

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

Dosage and Administration

This product is intended for use in pediatric patients, and healthcare professionals should refer to the dosage chart to determine the appropriate dose based on the patient's weight and age. It is essential to shake the product well before use. The enclosed dosing cup, specifically designed for this product, must be utilized; no other dosing devices should be employed.

The recommended dosing intervals are as follows: if necessary, the dose may be repeated every 4 hours while symptoms persist. However, it is crucial not to exceed 5 doses within a 24-hour period. Additionally, treatment should not extend beyond 5 days unless directed by a physician.

Dosage Chart:

• For patients weighing less than 24 lb and under 2 years of age, the dose is to be determined by a doctor.

• For patients weighing 24-35 lb and aged 2-3 years, the dose is 5 mL.

• For patients weighing 36-47 lb and aged 4-5 years, the dose is 7.5 mL.

• For patients weighing 48-59 lb and aged 6-8 years, the dose is 10 mL.

• For patients weighing 60-71 lb and aged 9-10 years, the dose is 12.5 mL.

• For patients weighing 72-95 lb and aged 11 years, the dose is 15 mL.

Healthcare professionals should ensure that patients do not exceed the recommended dosages and should consult a physician for any uncertainties or if symptoms persist.

Contraindications

Use of this product is contraindicated in the following situations:

• Co-administration with any other drug containing acetaminophen, whether prescription or non-prescription, 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.

• In patients with a known allergy to acetaminophen or any of the inactive ingredients in this formulation, as this may lead to severe allergic reactions.

• Exceeding the recommended dosage is contraindicated due to the potential for overdose and associated health risks.

Warnings and Precautions

This product contains acetaminophen, which poses a risk of severe liver damage if the maximum daily dosage is exceeded. Specifically, healthcare professionals should advise caregivers that no more than five doses should be administered within a 24-hour period. Additionally, caution is warranted when this product is used concurrently with other medications containing acetaminophen.

Severe skin reactions have been associated with acetaminophen use. Symptoms indicative of such reactions may include skin reddening, blisters, and rash. In the event of any skin reaction, it is imperative to discontinue use immediately and seek medical assistance.

Healthcare providers should be vigilant regarding the potential for severe sore throat symptoms. If a sore throat is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, prompt consultation with a physician is recommended.

General precautions should be observed, particularly in patients with pre-existing conditions. It is advisable to consult a physician before administering this product to children with liver disease. Furthermore, caregivers should seek guidance from a doctor or pharmacist if the child is concurrently taking the anticoagulant warfarin.

In cases of suspected overdose, immediate medical attention is critical. Caregivers should contact a Poison Control Center at 1-800-222-1222 without delay, even if no symptoms are apparent.

Healthcare professionals should instruct caregivers to discontinue use and consult a physician if new symptoms arise, if redness or swelling occurs, if pain worsens or persists beyond five days, or if fever intensifies or lasts more than three days. These symptoms 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 amount of acetaminophen, which is more than 5 doses in 24 hours, is exceeded or if it is taken concurrently with other medications containing acetaminophen. Patients should also be alerted to the risk of severe skin reactions associated with acetaminophen, which may manifest as skin reddening, blisters, or rash. In the event of a skin reaction, it is imperative to discontinue use and seek medical assistance immediately.

In cases of severe sore throat that persists for more than 2 days or is accompanied by fever, headache, rash, nausea, or vomiting, patients should consult a healthcare professional promptly.

This product should not be used in conjunction with any other drug containing acetaminophen, whether prescription or non-prescription. Patients are advised to consult a doctor or pharmacist if they are uncertain whether a drug contains acetaminophen. Additionally, individuals with known allergies to acetaminophen or any inactive ingredients in this product should refrain from use.

Before using this product, patients with liver disease should seek medical advice. Furthermore, those taking the blood-thinning medication warfarin should consult a healthcare provider or pharmacist prior to use.

While using this product, it is crucial not to exceed the recommended dosage. Patients should discontinue use and consult a doctor if new symptoms arise, if redness or swelling occurs, if pain worsens or persists for more than 5 days, or if fever intensifies or lasts more than 3 days, as these may indicate a serious condition.

An overdose warning is also pertinent; taking more than the recommended dose may lead to liver damage. In the event of an overdose, immediate medical help should be sought, or contact with a Poison Control Center (1-800-222-1222) is advised. Quick medical attention is critical, even if no signs or symptoms are immediately apparent.

Drug Interactions

Patients should consult a healthcare professional prior to using acetaminophen if they are concurrently taking warfarin, a blood-thinning medication. Acetaminophen may interact with warfarin, potentially influencing International Normalized Ratio (INR) levels. Monitoring of INR may be warranted to ensure therapeutic efficacy and safety.

No additional drug interactions or laboratory test interactions have been identified for acetaminophen.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 2 years of age should consult a doctor before use. For children aged 2 to 3 years, the recommended dosage is 5 mL; for those aged 4 to 5 years, 7.5 mL; for ages 6 to 8 years, 10 mL; for 9 to 10 years, 12.5 mL; and for 11 years, 15 mL. The maximum daily dosage should not exceed 5 doses within a 24-hour period, and the duration of use should not exceed 5 days unless directed by a healthcare professional.

Safety considerations include the necessity to consult a doctor before use if the child has liver disease or is taking the anticoagulant warfarin. There is an allergy alert for acetaminophen, which may cause severe skin reactions, including symptoms such as skin reddening, blisters, and rash. If any skin reaction occurs, use should be discontinued immediately, and medical assistance should be sought. Additionally, if a sore throat is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, a doctor should be consulted promptly.

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 efficacy, given the lack of targeted data for this population.

Pregnancy

The available prescribing information does not provide specific data regarding the use of acetaminophen during pregnancy. Consequently, there are no established safety concerns, dosage modifications, or special precautions outlined for pregnant patients. Healthcare professionals should exercise caution and consider the potential risks and benefits when recommending acetaminophen to women of childbearing potential. Further research may be necessary to fully understand the implications of acetaminophen use during pregnancy and its potential effects on fetal outcomes.

Lactation

Nursing mothers should consult a doctor before using this product. There is a potential for excretion of acetaminophen in breast milk. Caution is advised when administering this product to nursing mothers due to the potential risk to the infant.

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 be closely monitored 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 five doses within a 24-hour period, as this represents the maximum daily amount. Additionally, patients should avoid concomitant use with other medications containing acetaminophen to prevent the risk of hepatotoxicity.

Before initiating treatment, it is advisable for patients with liver disease to consult a healthcare professional. This precaution is essential to ensure the safe use of the product and to evaluate the potential need for dosage adjustments or alternative therapies based on the severity of liver function impairment. Regular monitoring of liver function may be warranted in these patients to detect any signs of liver injury early.

Overdosage

Taking more than the recommended dose of this medication may lead to significant liver damage. 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.

Recommended Actions

Prompt medical attention is crucial, even if the individual does not exhibit any noticeable signs or symptoms of overdose. Healthcare professionals should be prepared to assess the patient's condition and initiate appropriate interventions as necessary.

Potential Symptoms

While specific symptoms of overdose may not be detailed, the risk of liver damage underscores the importance of vigilance and timely response in suspected cases of overdose.

In summary, healthcare providers must prioritize rapid evaluation and management in cases of overdose to mitigate potential complications associated with liver damage.

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 compound in these areas.

Postmarketing Experience

Severe skin reactions have been reported in association with acetaminophen use, including symptoms such as skin reddening, blisters, and rash. In the event of a skin reaction, it is advised to discontinue use and seek medical assistance immediately.

Additionally, cases of overdose have been documented, which may lead to liver damage. It is crucial for individuals who suspect an overdose to obtain medical help or contact a Poison Control Center (1-800-222-1222) without delay, as prompt medical attention is essential, even in the absence of noticeable signs or symptoms.

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 be instructed to seek medical help immediately or contact a Poison Control Center at 1-800-222-1222, as prompt medical attention is crucial even if no signs or symptoms are initially present.

Patients should be cautioned against using this product in conjunction with any other medications that contain acetaminophen, whether prescription or non-prescription. If patients are uncertain about the presence of acetaminophen in other medications, they should be encouraged to consult with a doctor or pharmacist.

It is important to inform patients that this product should not be used if their child has a known allergy to acetaminophen or any of the inactive ingredients contained in the formulation. Healthcare providers should also instruct patients to discontinue use and consult a doctor if new symptoms arise, if there is any redness or swelling, if pain worsens or persists beyond five days, or if fever intensifies or lasts more than three days, as these may indicate a serious condition.

Patients should be reminded to adhere strictly to the recommended dosage to avoid the risk of overdose. Additionally, healthcare providers should recommend that patients consult a doctor before using this product if their child has liver disease. Lastly, 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 configurations that include specific NDC numbers, which can be found on the packaging. It is essential to store the product at a temperature range of 20-25ºC (68-77ºF). Refrigeration is not permitted, as it may compromise the integrity of the product. For traceability, the lot number and expiration date are located on the bottom panel of the packaging. Proper adherence to these storage conditions is crucial for maintaining product efficacy and safety.

Additional Clinical Information

The medication is administered orally, with a recommended dosing frequency of every 4 hours as needed while symptoms persist. Clinicians should advise patients not to exceed 5 doses within a 24-hour period and to limit use to a maximum of 5 days unless otherwise directed by a healthcare professional.

Drug Information (PDF)

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

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