Relief-Pe

Description

No specific description details are available for SPL code 34089-3.

Uses and Indications

This drug is indicated for the temporary relief of nasal congestion, sinus pressure, and minor aches and pains associated with the common cold, hay fever, upper respiratory allergies, headache, itchy or watery eyes, runny nose, and muscular aches. Additionally, it is indicated for the temporary reduction of fever.

Limitations of Use: This drug is not intended for the treatment of chronic conditions or for prolonged use beyond the recommended duration.

Dosage and Administration

Adults and children 12 years of age and over are advised to take 1 to 2 tablets every 6 hours as needed while symptoms persist. It is imperative that they do not exceed a total of 8 tablets within a 24-hour period unless specifically directed by a healthcare professional.

For children under 12 years of age, the use of this medication is contraindicated, as it may lead to an overdose and potential liver damage.

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 and potential hepatotoxicity.

• Concurrent use with prescription monoamine oxidase inhibitors (MAOIs) or within 2 weeks of discontinuing an MAOI. This includes certain medications prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease, as it may lead to serious drug interactions and adverse effects. If the presence of an MAOI in the patient's medication regimen is uncertain, use of this product is also contraindicated.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen. Healthcare professionals should advise patients to adhere strictly to the following guidelines to mitigate the risk of liver injury. Patients must not exceed 8 tablets within a 24-hour period, as this is the maximum daily dosage. Additionally, the concurrent use of other medications containing acetaminophen is contraindicated. Consumption of three or more alcoholic beverages daily while using this product is also discouraged due to the increased risk of liver damage.

In terms of general precautions, this product should not be used in conjunction with any other drug that contains acetaminophen, whether prescription or non-prescription. Furthermore, patients currently taking a prescription monoamine oxidase inhibitor (MAOI) for conditions such as depression, psychiatric disorders, or Parkinson's disease should refrain from using this product. This includes a two-week period following the cessation of MAOI therapy. If patients are uncertain whether their prescription includes an MAOI, they should consult their healthcare provider before use.

Patients are advised to discontinue use and consult a physician if they experience any of the following: nervousness, dizziness, sleeplessness, the emergence of new symptoms, a fever that worsens or persists beyond three days, worsening pain or nasal congestion lasting more than seven days, or the presence of redness or swelling. These symptoms may indicate a need for further medical evaluation.

No specific instructions for obtaining emergency medical help are provided; however, healthcare professionals should remain vigilant and encourage patients to seek immediate assistance if they experience severe adverse reactions or symptoms indicative of a serious condition.

Side Effects

Severe liver damage may occur in patients who exceed the maximum daily dosage of 8 tablets within a 24-hour period, particularly when combined with other medications containing acetaminophen or when consuming three or more alcoholic drinks daily while using this product. Overdose, defined as taking more than the recommended dose, poses a significant risk of liver damage, necessitating prompt medical attention for both adults and children, even in the absence of noticeable signs or symptoms.

Patients are advised to discontinue use and consult a healthcare professional if they experience symptoms such as nervousness, dizziness, or sleeplessness, if new symptoms arise, if fever worsens or persists beyond three days, if pain or nasal congestion intensifies or lasts more than seven days, or if redness or swelling occurs, as these may indicate a serious condition.

Prior to use, patients should seek medical advice if they have a history of heart, liver, or thyroid disease, high blood pressure, diabetes, glaucoma, difficulty urinating due to an enlarged prostate gland, or respiratory issues such as emphysema or chronic bronchitis. Additionally, it is recommended that patients consult a doctor or pharmacist if they are currently taking sedatives or tranquilizers, the anticoagulant warfarin, or if they are uncertain whether other medications they are taking contain acetaminophen.

Drug Interactions

Concurrent use of this medication with other products containing acetaminophen, whether prescription or non-prescription, is contraindicated due to the risk of acetaminophen overdose.

The use of this medication is also contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such treatment. This includes certain medications prescribed for depression, psychiatric disorders, or Parkinson's disease. Patients should be advised to confirm whether their prescription includes an MAOI before initiating treatment.

Caution is advised when using this medication in conjunction with sedatives or tranquilizers. Patients should consult a healthcare professional prior to use if they are currently taking these types of medications.

Additionally, patients taking the anticoagulant warfarin should seek guidance from a healthcare provider before using this medication, as potential interactions may affect anticoagulation control.

It is important to note that the combined use of alcohol, sedatives, and tranquilizers with this medication may enhance drowsiness, necessitating careful monitoring of patients for increased sedation effects.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 12 years of age should not use this medication, as it may result in an overdose that could lead to liver damage. For adolescents aged 12 years and older, the recommended dosage is 1 to 2 tablets every 6 hours as needed while symptoms persist, with a maximum of 8 tablets in a 24-hour period unless otherwise directed by a healthcare professional.

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. 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.

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 available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

Hepatic Impairment

Patients with hepatic impairment should be closely monitored due to the potential risk of severe liver damage associated with the use of this product, which contains acetaminophen. It is critical that patients do not exceed the maximum daily dosage of 8 tablets within a 24-hour period. Additionally, patients must avoid concomitant use of other medications containing acetaminophen, as this can further increase the risk of hepatotoxicity.

Furthermore, patients who consume three or more alcoholic beverages daily should exercise caution when using this product, as alcohol can exacerbate the risk of liver injury. Regular assessment of liver function may be warranted in patients with compromised liver function to ensure safety and efficacy while using this medication.

Overdosage

Taking more than the recommended dose of this medication can lead to serious health consequences, particularly liver damage. It is imperative that healthcare professionals recognize the urgency of the situation and act swiftly.

In the event of an overdose, immediate medical attention is crucial for both adults and children, regardless of whether any signs or symptoms are present. Symptoms of liver damage may not be immediately apparent, which underscores the importance of prompt intervention.

Healthcare providers should advise patients or caregivers to seek medical help or contact a Poison Control Center without delay. The national Poison Control Center can be reached at 1-800-222-1222 for guidance on managing overdose situations.

Timely and appropriate management is essential to mitigate the risks associated with overdose and to ensure the best possible outcomes for affected individuals.

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 several adverse reactions reported voluntarily or through surveillance programs. These include nervousness, dizziness, sleeplessness, and the emergence of new symptoms.

Additionally, it has been noted that fever worsening or persisting for more than three days, pain or nasal congestion worsening or lasting for more than seven days, and the presence of redness or swelling may indicate the potential for a serious condition.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. Patients should be instructed not to use this product in conjunction with any other medications containing acetaminophen, whether prescription or non-prescription, to avoid the risk of overdose.

It is essential to inform patients that they should not use this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have taken one within the last two weeks. Patients should be encouraged to consult their healthcare provider if they are uncertain whether their prescription medication contains an MAOI.

Patients should be made aware that they need to stop using the product and seek medical advice if they experience symptoms such as nervousness, dizziness, or sleeplessness. Additionally, they should be instructed to discontinue use and consult a doctor if new symptoms arise, if fever worsens or persists for more than three days, or if pain or nasal congestion worsens or lasts longer than seven days. They should also be advised to seek medical attention if they notice any redness or swelling, as these may indicate a serious condition.

When using this product, patients must be cautioned not to exceed the recommended dosage. They should be informed that the product may cause excitability or drowsiness, and that the effects may be intensified by alcohol, sedatives, or tranquilizers. Patients should exercise caution when driving or operating machinery.

Healthcare providers should encourage patients to consult a doctor before using this product if they have any of the following conditions: heart disease, liver disease, thyroid disease, high blood pressure, diabetes, glaucoma, or difficulty urinating due to an enlarged prostate gland. Patients with breathing problems, such as emphysema or chronic bronchitis, should also seek medical advice prior to use.

Finally, patients should be advised to consult a doctor or pharmacist before using this product if they are taking sedatives, tranquilizers, or the blood-thinning medication warfarin. They should also be encouraged to ask for guidance if they are unsure whether any other medications they are taking contain acetaminophen.

Storage and Handling

The product is supplied in packaging that includes specific NDC numbers. It should be stored at a temperature range of 20°C to 25°C (68°F to 77°F), with permissible excursions between 15°C to 30°C (59°F to 86°F). It is essential to protect the product from light to maintain its integrity. Additionally, the product must be kept out of reach of children, and any unused portion should be discarded after opening to ensure safety and efficacy.

Additional Clinical Information

Patients aged 12 years and older are advised to take 1 to 2 tablets orally every 6 hours while symptoms persist, with a maximum of 8 tablets in a 24-hour period unless otherwise directed by a healthcare provider. For children under 12 years of age, the medication is not recommended due to the risk of overdose and potential liver damage.

Clinicians should counsel patients to consult a doctor or pharmacist prior to use if they are taking sedatives or tranquilizers, or if they have a history of heart, liver, or thyroid disease, high blood pressure, diabetes, glaucoma, urinary issues related to an enlarged prostate, or respiratory conditions such as emphysema or chronic bronchitis. Additionally, pregnant or breastfeeding patients should seek professional advice before using this medication.

Drug Information (PDF)

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

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