Pain Reliever Plus

Description

The product is identified by the SPL code 34089-3. No additional specific description details are provided in the available data.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with headache and muscular aches.

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

Dosage and Administration

Adults and children aged 12 years and older are instructed to take 2 tablets every 6 hours, with a maximum dosage of 8 tablets within a 24-hour period. For children under 12 years of age, it is recommended to consult a physician for appropriate dosing guidance.

It is essential to adhere strictly to the recommended dosage and not exceed the directed amount.

Contraindications

Use is contraindicated in patients with a known allergy to acetaminophen. Additionally, concurrent use with any other medication containing acetaminophen, whether prescription or non-prescription, is contraindicated. If there is uncertainty regarding the presence of acetaminophen in a medication, consultation with a healthcare professional is advised.

Warnings and Precautions

Acetaminophen may cause severe skin reactions, which can manifest as skin reddening, blisters, or rash. In the event of any skin reaction, it is imperative to discontinue use immediately and seek medical assistance.

This product contains acetaminophen, which poses a risk of severe liver damage if the following conditions are met: exceeding the maximum daily dosage of 8 tablets within a 24-hour period, concurrent use with other medications containing acetaminophen, or the consumption of three or more alcoholic beverages daily while using this product. Healthcare professionals should monitor patients for signs of liver dysfunction, particularly in those who may be at increased risk.

The recommended dosage of this product contains approximately the same amount of caffeine as a standard cup of coffee. It is advisable to limit the intake of other caffeine-containing medications, foods, or beverages during treatment, as excessive caffeine consumption may lead to symptoms such as nervousness, irritability, sleeplessness, and, in some cases, rapid heartbeat.

In cases of overdose, immediate medical attention is crucial. Patients or caregivers should contact a Poison Control Center at 1-800-222-1222 without delay, even if no symptoms are apparent, as prompt intervention is essential for both adults and children.

Healthcare providers should advise patients to consult a physician prior to use if they have a history of liver disease. Additionally, patients taking the anticoagulant warfarin should seek guidance from a healthcare professional or pharmacist before using this product.

Patients should be instructed to discontinue use and contact their healthcare provider if any new symptoms arise, if the painful area becomes red or swollen, if pain worsens or persists for more than 10 days, or if fever intensifies or lasts longer than 3 days, as these may indicate a serious underlying condition.

In summary, vigilance is required when prescribing or recommending this product, with particular attention to the potential for severe adverse reactions and the necessity for monitoring specific health parameters.

Side Effects

Patients using this product should be aware of potential adverse reactions, which can range from serious to common.

Severe skin reactions have been reported in patients taking acetaminophen, characterized by symptoms such as skin reddening, blisters, and rash. If any of these symptoms occur, patients are advised to discontinue use immediately and seek medical assistance.

There is a significant risk of severe liver damage associated with this product, particularly if patients exceed the maximum recommended dosage of 8 tablets in 24 hours, use other medications containing acetaminophen concurrently, or consume three or more alcoholic drinks daily while using this product. Patients with pre-existing liver disease should consult a healthcare professional before using this medication.

Caffeine is also a component of this product, and the recommended dose contains approximately the same amount of caffeine as a cup of coffee. Patients are cautioned to limit the intake of other caffeine-containing medications, foods, or beverages, as excessive caffeine consumption may lead to symptoms such as nervousness, irritability, sleeplessness, and, in some cases, rapid heartbeat.

Patients should discontinue use and consult a healthcare provider if they experience any new symptoms, if a painful area becomes red or swollen, if pain worsens or persists for more than 10 days, or if fever intensifies or lasts longer than 3 days, as these may indicate a serious condition.

Additionally, patients taking the blood-thinning medication warfarin should seek advice from a doctor or pharmacist prior to using this product to avoid potential interactions.

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 ensure therapeutic efficacy and minimize the risk of bleeding complications. 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 Pain Reliever Plus (acetaminophen, caffeine). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients 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, with a maximum of 8 tablets in a 24-hour period.

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. 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 the safety of both the mother and the developing fetus or nursing infant.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is no specific data available regarding the excretion of this medication in 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 available data 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 lack of information necessitates careful clinical judgment and monitoring of these patients.

Hepatic Impairment

Patients with hepatic impairment should be closely monitored when using this product, which contains acetaminophen. It is important to note that severe liver damage may occur if patients exceed the maximum daily dosage of 8 tablets within a 24-hour period. Additionally, patients should avoid concomitant use of other medications containing acetaminophen, as this can further increase the risk of liver injury.

Patients with compromised liver function are also advised to limit alcohol consumption. Specifically, the intake of 3 or more alcoholic drinks per day while using this product may significantly heighten the risk of severe liver damage. Therefore, careful consideration of liver function and adherence to recommended dosage guidelines is essential for patients with hepatic impairment to mitigate potential risks.

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 intervention is essential for both adults and children, regardless of whether any signs or symptoms are apparent.

Healthcare professionals should be aware that the absence of symptoms does not preclude the possibility of serious complications. Therefore, it is crucial to monitor the patient closely and provide appropriate care as needed.

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

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. Patients should be informed not to use the medication if they have a known allergy to acetaminophen. It is important to counsel patients against using this medication in conjunction with any other products that contain acetaminophen, whether prescription or non-prescription. If patients are uncertain about the contents of a medication, they should be encouraged to consult with a doctor or pharmacist.

Patients should be instructed to discontinue use and seek medical advice if they experience any new symptoms. Additionally, they should be advised to stop using the medication and consult a doctor if the painful area becomes red or swollen, if the pain worsens or persists for more than 10 days, or if a fever intensifies or lasts longer than 3 days, as these may indicate a serious condition.

Furthermore, healthcare providers should recommend that patients with liver disease consult a doctor before using this medication. Patients taking the blood-thinning medication warfarin should also be advised 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 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 within the specified temperature limits to prevent degradation.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)