Physicianscare Allergy

Description

No description information is available for the specified drug.

Uses and Indications

This drug is indicated for the temporary relief of symptoms associated with hay fever and other upper respiratory allergies. These symptoms include nasal congestion, headache, itchy and watery eyes, itching of the nose and throat, runny nose, sneezing, minor aches and pains, as well as sinus congestion and pressure.

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 4 hours as needed. The total dosage must not exceed 12 tablets within a 24-hour period to avoid potential overdose.

For children under 12 years of age, this medication is contraindicated and should not be administered.

Contraindications

Use of this product is contraindicated in the following situations:

• Co-administration with any other drug containing acetaminophen, whether prescription or nonprescription, due to the risk of acetaminophen overdose. If uncertain about the presence of acetaminophen in other medications, consult a healthcare professional.

• Use for pain exceeding 10 days without medical supervision is contraindicated, as prolonged use may lead to adverse effects.

• Use for fever beyond 3 days without medical guidance is contraindicated to prevent potential complications.

• Co-administration with any other drug containing the same active ingredients is contraindicated to avoid cumulative effects.

• Concurrent use with prescription monoamine oxidase inhibitors (MAOIs) is contraindicated, as this may lead to serious interactions. This includes MAOIs used for depression, psychiatric or emotional conditions, or Parkinson’s disease, and extends for 2 weeks after discontinuation of the MAOI. If there is uncertainty regarding the presence of an MAOI in a prescription, consult a healthcare professional before use.

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:

• Do not exceed 4,000 mg of acetaminophen within a 24-hour period, as this is the maximum recommended daily dosage.

• Avoid concurrent use with other medications that contain acetaminophen.

• Limit alcohol consumption to fewer than three alcoholic drinks per day while using this product.

Patients should be informed of the potential for severe skin reactions associated with acetaminophen. Symptoms indicative of such reactions may include skin reddening, blisters, and rash. In the event of a skin reaction, patients must discontinue use immediately and seek medical assistance.

Healthcare professionals should instruct patients to stop using the product and consult a physician if any of the following occur:

• Symptoms do not improve within 7 days or are accompanied by a fever.

• Pain or fever persists or worsens.

• New symptoms develop.

• Redness or swelling is observed.

In cases of suspected overdose, it is imperative to seek emergency medical help or contact a Poison Control Center without delay. Prompt medical attention is essential for both adults and children, even if no signs or symptoms are immediately apparent.

Side Effects

Patients using this product should be aware of the potential for serious adverse reactions, particularly related to liver health and allergic skin responses.

Severe liver damage may occur if patients exceed the maximum recommended dosage of 4,000 mg of acetaminophen within a 24-hour period, take this product in conjunction with other medications containing acetaminophen, or consume three or more alcoholic drinks daily while using this product.

Additionally, there is an allergy alert associated with acetaminophen, as it may lead to severe skin reactions. Symptoms of such reactions can include skin reddening, blisters, and rash. In the event of a skin reaction, patients are advised to discontinue use immediately and seek medical assistance.

These warnings highlight the importance of adhering to dosage guidelines and monitoring for any signs of adverse reactions during treatment.

Drug Interactions

There are currently no documented drug interactions associated with the use of this medication. Additionally, there is no information available regarding 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 Physicianscare Allergy (acetaminophen, chlorpheniramine maleate, phenylephrine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Children under 12 years of age should not be administered this medication. For pediatric patients aged 12 years and older, the recommended dosage is 2 tablets every 4 hours, with a maximum of 12 tablets in a 24-hour period.

Healthcare professionals should be aware that excitability may occur, particularly in children. It is essential to seek prompt medical attention for both adults and pediatric patients, even in the absence of noticeable signs or symptoms.

Geriatric Use

Elderly patients may not have specific dosage adjustments, safety concerns, or special precautions outlined in the prescribing information. Therefore, healthcare providers should exercise clinical judgment when prescribing this medication to geriatric patients, particularly those aged 65 and older.

It is advisable to monitor these patients closely for any potential adverse effects or changes in therapeutic response, as age-related physiological changes may influence drug metabolism and efficacy.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is important to assess the potential risks and benefits, as well as any available data regarding fetal outcomes and lactation. Healthcare providers can offer guidance tailored to individual circumstances, ensuring the safety of both the patient 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 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 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 4,000 mg of acetaminophen within a 24-hour period. Additionally, patients should avoid the concurrent 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 three or more alcoholic drinks per day while using this product may significantly heighten the risk of liver damage. Therefore, careful consideration of liver function and adherence to recommended dosage guidelines is essential for patients with hepatic impairment to minimize the risk of adverse effects.

Overdosage

In cases of acetaminophen overdosage, severe liver damage may occur if an individual ingests more than 4,000 mg within a 24-hour period, which is the established maximum daily dosage.

Healthcare professionals should be vigilant for symptoms indicative of liver injury, which may not manifest immediately. Early signs can include nausea, vomiting, loss of appetite, confusion, and jaundice. It is crucial to monitor liver function tests in patients suspected of acetaminophen overdosage.

Management of acetaminophen overdosage typically involves the administration of N-acetylcysteine (NAC), which acts as an antidote. The effectiveness of NAC is highest when administered within 8 hours of ingestion; however, it may still provide benefits if given later. Healthcare providers should initiate treatment promptly and consider the patient's clinical status and timing of ingestion when determining the appropriate course of action.

In summary, awareness of the risks associated with acetaminophen overdosage and timely intervention are essential in preventing severe hepatic complications.

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 the following adverse reactions associated with acetaminophen use: severe skin reactions, which include skin reddening, blisters, and rash. These events have been reported voluntarily or through surveillance programs.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of the reach of children. In the event of an overdose, it is crucial to seek medical help or contact a Poison Control Center immediately, as prompt medical attention is essential 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 containing acetaminophen, whether prescription or nonprescription. If patients are uncertain whether a drug contains acetaminophen, they should consult a doctor or pharmacist. Additionally, patients should be cautioned against using this medication for more than 10 days for pain or more than 3 days for fever unless directed by a healthcare professional.

It is important to instruct patients not to use this medication with any other drugs that contain the same active ingredients. Patients should also be made aware that this medication should not be used if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of stopping an MAOI. If patients are unsure whether their prescription includes an MAOI, they should seek guidance from a doctor or pharmacist.

Patients should be advised to stop using the medication and consult a doctor if symptoms do not improve within 7 days, if they experience a fever, if pain or fever persists or worsens, if any new symptoms arise, or if redness or swelling occurs.

When using this product, patients may experience drowsiness and should be cautioned to avoid alcoholic beverages, as alcohol, sedatives, and tranquilizers can enhance the drowsiness effect. Patients should exercise caution when driving or operating machinery. It is also important to inform patients that excitability may occur, particularly in children.

Healthcare providers should recommend that patients consult a doctor before using this medication if they have any of the following conditions: liver disease, thyroid disease, diabetes, high blood pressure, heart disease, glaucoma, chronic bronchitis or emphysema, or difficulty urinating due to prostate gland enlargement. Furthermore, patients should be advised to speak with a doctor or pharmacist if they are taking the blood-thinning medication warfarin or any sedatives or tranquilizers.

Storage and Handling

The product is supplied in tamper-evident sealed packets to ensure safety and integrity. It is essential to store the product at room temperature, specifically within the range of 59ºF to 86ºF (15ºC to 30ºC). Care should be taken to avoid exposure to excessive heat and humidity, as these conditions may compromise the product's quality. Opened or torn packets should not be used to maintain the efficacy and safety of the product.

Additional Clinical Information

The medication is administered orally. For adults and children aged 12 years and older, the recommended dosage is 2 tablets every 4 hours, with a maximum of 12 tablets in a 24-hour period. It is contraindicated for children under 12 years of age.

Clinicians should counsel patients to consult a health professional if they are pregnant or breastfeeding. Additionally, it is important to keep the medication out of reach of children. In the event of an overdose, patients should seek immediate medical assistance or contact a Poison Control Center, as prompt attention is crucial for both adults and children, even if no symptoms are apparent.

Drug Information (PDF)

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

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