Defensol D

Description

Defensol D is presented in tablet form. The specific formulation and composition details are encapsulated in the product label. The tablets are designed for oral administration and are characterized by their distinct appearance, which is specified in the labeling. Further information regarding the molecular weight, chemical formula, and inactive ingredients is provided in the comprehensive product documentation.

Uses and Indications

This drug is indicated for the temporary relief of symptoms associated with cold or flu, including headache, nasal congestion, sore throat, fever, and minor aches and pains. Additionally, it is indicated for the temporary relief of minor aches, pains, and headache, as well as symptoms of hay fever or other upper respiratory allergies, such as runny nose, sneezing, nasal congestion, itching of the nose or throat, and itchy, watery eyes.

Furthermore, this drug provides temporary relief from minor aches, pains, headache, and nasal congestion, while also alleviating sinus congestion and pressure, and reducing swelling of the nasal passages.

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

Dosage and Administration

The maximum recommended dosage for this medication is 8 tablets within a 24-hour period.

For adults and children aged 12 years and older, the recommended dosage is 2 tablets every 4 hours as needed. It is important to adhere to this dosing schedule and not exceed the maximum daily limit.

This medication is not recommended for use in children under 12 years of age. Healthcare professionals should ensure that patients are aware of these guidelines to prevent potential overdose and ensure safe administration.

Contraindications

Use of this product is contraindicated in the following situations:

Patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or those who have discontinued MAOI therapy within the past two weeks. The combination may lead to serious interactions. If uncertain whether a prescription contains an MAOI, consult a healthcare professional.

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

This product should not be used to sedate a child or induce sleepiness in pediatric patients. Additionally, it is contraindicated to exceed the recommended dosage.

Consumption of alcoholic beverages is discouraged, as alcohol may enhance drowsiness when combined with this product.

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 recommended dosage guidelines. Specifically, patients must not exceed 8 tablets within a 24-hour period, which is the maximum daily amount. Caution is also warranted when this product is used in conjunction with other medications containing acetaminophen, as this can increase the risk of liver injury. Additionally, patients should be informed that consuming 3 or more alcoholic drinks daily while using this product may further elevate the risk of liver damage.

In cases of severe sore throat, patients should be instructed to seek medical attention if the sore throat persists for more than 2 days or is accompanied by other concerning symptoms such as fever, headache, rash, nausea, or vomiting.

Healthcare professionals should advise patients to discontinue use and consult a doctor if they experience any of the following: nervousness, dizziness, or sleeplessness; worsening pain or nasal congestion lasting more than 7 days; fever that worsens or persists for more than 3 days; the presence of redness or swelling; or the emergence of new symptoms. Monitoring for these signs is essential to ensure patient safety and effective management of their condition.

Side Effects

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

Severe liver damage may occur with the use of this product, particularly if patients exceed the maximum daily dosage of 8 tablets within a 24-hour period, combine it with other medications containing acetaminophen, or consume 3 or more alcoholic drinks daily while using the product. In the event of an overdose, it is crucial for patients to seek medical help or contact a Poison Control Center immediately, as prompt medical attention is essential for both adults and children, even in the absence of noticeable symptoms.

Patients are advised to discontinue use and consult a doctor if they experience nervousness, dizziness, or sleeplessness. Additionally, if pain or nasal congestion worsens or persists beyond 7 days, if fever intensifies or lasts more than 3 days, if redness or swelling occurs, or if new symptoms arise, medical advice should be sought.

Before using this product, patients should consult a doctor if they have any pre-existing conditions, including liver disease, heart disease, high blood pressure, thyroid disease, diabetes, difficulty urinating due to an enlarged prostate gland, glaucoma, or respiratory issues such as emphysema, asthma, or chronic bronchitis. Furthermore, patients taking the blood-thinning medication warfarin, any other oral nasal decongestants or stimulants, additional pain relievers or fever reducers, or sedatives or tranquilizers should also seek guidance from a doctor or pharmacist prior to use.

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 doctor promptly.

Drug Interactions

Concurrent use of this medication with any other drug containing acetaminophen, whether prescription or non-prescription, is contraindicated due to the risk of acetaminophen overdose and potential hepatotoxicity.

Patients taking the anticoagulant warfarin should consult a healthcare professional prior to using this medication, as there may be an increased risk of bleeding due to potential interactions.

Caution is advised for individuals using other oral nasal decongestants or stimulants. Consultation with a healthcare provider is recommended to assess the risk of additive effects.

Patients should also seek guidance from a healthcare professional if they are using any other pain relievers or fever reducers, as this may lead to an increased risk of adverse effects.

The use of this medication in conjunction with sedatives or tranquilizers warrants careful consideration. Patients are advised to consult a healthcare provider, as the combination may enhance sedative effects.

Additionally, the concurrent consumption of alcohol, sedatives, and tranquilizers may lead to increased drowsiness. Monitoring for excessive sedation is recommended in patients using these substances together.

Packaging & NDC

Below are the non-prescription pack sizes of Defensol D (acetaminophen, chlorpherinamine maleate, phenylephrine hci). 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 2 tablets every 4 hours.

Healthcare professionals should be aware that excitability may occur in pediatric patients, and drowsiness is a potential side effect. It is important to keep this medication out of reach of children. In the event of an overdose, prompt medical attention is critical for children, even if no signs or symptoms are immediately apparent.

Geriatric Use

Elderly patients may not have specific geriatric use information available for this medication. However, it is essential for healthcare providers to exercise caution when prescribing to this population. Patients aged 65 and older should be advised to consult a physician prior to use if they have any of the following conditions: liver disease, heart disease, high blood pressure, thyroid disease, diabetes, difficulty urinating due to an enlarged prostate gland, glaucoma, or respiratory issues such as emphysema, asthma, or chronic bronchitis.

While there are no specific dosage adjustments indicated for geriatric patients, it is important to monitor for potential adverse effects. Special precautions should be taken regarding the use of alcohol, sedatives, and tranquilizers, as these substances may enhance drowsiness. Elderly patients should be cautioned about the risks associated with driving a motor vehicle or operating machinery while using this medication.

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 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 no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the text. Therefore, healthcare professionals should exercise caution and consider individual patient factors when prescribing to this population. Regular assessment of renal function may be warranted to ensure safe and effective use of the medication in patients with reduced kidney function.

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 with 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 liver damage. Therefore, careful consideration of liver function and adherence to the recommended dosage guidelines is essential to minimize the potential for adverse effects in this patient population.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Prompt intervention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Healthcare professionals should be aware that the lack of immediate symptoms does not preclude the potential for serious health consequences. Therefore, vigilance and timely action are essential in managing overdose situations effectively.

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 question. Further studies may be necessary to elucidate these aspects of nonclinical toxicology.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions reported voluntarily or through surveillance programs. These include nervousness, dizziness, sleeplessness, and increased drowsiness. Additionally, reports of severe liver damage associated with overdose have been noted. Instances of allergic reactions, including rash, itching, and swelling, have also been documented. Gastrointestinal disturbances such as nausea and vomiting have been observed. Furthermore, excitability in children has been reported with the use of this product.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children and to refrain from using it to sedate a child or induce sleepiness. It is crucial to inform patients that they should not use this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have stopped taking an MAOI drug within the last two weeks. Patients should be encouraged to consult a doctor or pharmacist if they are uncertain whether their prescription medication contains an MAOI.

Patients must be cautioned against using this product in conjunction with any other drug containing acetaminophen, whether prescription or non-prescription. If patients are unsure whether a drug contains acetaminophen, they should seek guidance from a healthcare professional.

Patients should be instructed to stop using the product and consult a doctor if they experience nervousness, dizziness, or sleeplessness. Additionally, they should seek medical advice if pain or nasal congestion worsens or persists for more than seven days, if fever worsens or lasts more than three days, if redness or swelling occurs, or if new symptoms develop.

When using this product, patients should adhere strictly to the recommended dosage and be aware that excitability may occur in children. Drowsiness is a potential side effect, and patients should be advised to avoid alcoholic beverages, as alcohol, sedatives, and tranquilizers may enhance drowsiness. Caution should be exercised when driving a motor vehicle or operating machinery.

Patients should be encouraged to consult a doctor before using this product if they have any of the following conditions: liver disease, heart disease, high blood pressure, thyroid disease, diabetes, difficulty urinating due to an enlarged prostate gland, glaucoma, or any breathing problems such as emphysema, asthma, or chronic bronchitis. Furthermore, patients should seek advice from a doctor or pharmacist if they are taking the blood-thinning medication warfarin, any other oral nasal decongestant or stimulant, any other pain reliever or fever reducer, or any sedatives or tranquilizers.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers, which should be referenced for accurate identification. It is essential to store the product at room temperature, maintaining a range of 20°C to 25°C (68°F to 77°F).

To ensure the integrity of the product, it must be protected from light and the container should remain tightly closed when not in use. Additionally, it is important to discard the product after opening to maintain safety and efficacy.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients who are pregnant or breastfeeding to consult a healthcare professional prior to use. It is essential to keep the medication out of reach of children. In the event of an overdose, patients must seek medical assistance or contact a Poison Control Center immediately, as prompt medical attention is crucial for both adults and children, even if no signs or symptoms are apparent.

Drug Information (PDF)

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

View product document (PDF)