Antiflu Des

Description

The product is identified by SPL code 34089-3 and is presented as a white to off-white, round, biconvex tablet. It is debossed with "A" on one side and "1" on the other side. Each tablet contains 1 mg of the active ingredient. The formulation includes inactive ingredients such as lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, magnesium stearate, and talc.

Uses and Indications

This drug is indicated for the temporary relief of common cold and flu symptoms, including sore throat, headache, minor aches and pains, fever, and symptoms associated with a stuffy or runny nose and sneezing.

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

Dosage and Administration

Adults and children 12 years of age and over are instructed to take 1 capsule with water every 4 hours as needed. The total dosage must not exceed 6 capsules within a 24-hour period.

The use of this medication is not recommended for children under 12 years of age.

Contraindications

Use of this product is contraindicated in the following situations:

The product should not be used in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription, due to the risk of acetaminophen overdose. Additionally, it is contraindicated for patients currently taking a prescription Monoamine Oxidase Inhibitor (MAOI) or those who have taken such products within the past two weeks, as this may lead to serious drug interactions.

The combination of this product with alcohol, sedatives, or tranquilizers is contraindicated, as these substances may enhance drowsiness and increase the risk of adverse effects.

Use is also contraindicated in pregnant or breastfeeding individuals unless advised by a healthcare professional. Patients should not exceed the recommended dosage, and if symptoms such as nervousness, dizziness, or sleeplessness occur, discontinuation and consultation with a physician are advised. Caution is warranted when driving a motor vehicle or operating machinery, as the product may impair these activities.

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 minimize the risk of liver injury: do not exceed 4,000 mg of acetaminophen in a 24-hour period, avoid concurrent use with other medications containing acetaminophen, and limit alcohol consumption to fewer than three drinks per day while using this product.

Patients should be informed of the potential for severe skin or allergic reactions associated with acetaminophen. Symptoms indicative of such reactions may include skin reddening, blisters, rash, hives, facial swelling, wheezing, and shock. In the event of any skin or allergic reaction, patients must discontinue use immediately and seek medical attention.

Healthcare professionals should also be vigilant regarding patients presenting with a severe or persistent sore throat lasting more than two days, or a sore throat accompanied by high fever, headache, nausea, or vomiting, as these symptoms may indicate a serious condition requiring prompt medical evaluation.

Patients are advised to stop use and consult a healthcare provider if any of the following occur: pain or nasal congestion worsens or persists beyond five days in children or seven days in adults; fever worsens or lasts more than three days; redness or swelling is observed; or new symptoms develop.

In cases of suspected accidental overdose, immediate medical assistance should be sought, or the Poison Control Center (1-800-222-1222) should be contacted. Prompt medical attention is essential for both adults and children, even in the absence of noticeable signs or symptoms.

Side Effects

Patients using this product should be aware of several important warnings and potential adverse reactions.

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

Additionally, acetaminophen may cause severe skin or allergic reactions. Symptoms of such reactions can include skin reddening, blisters, rash, hives, facial swelling, asthma (wheezing), and shock. In the event of any skin or allergic reaction, patients are advised to discontinue use immediately and seek medical attention.

Patients should also be cautious of severe or persistent sore throat symptoms lasting more than two days, or a sore throat accompanied by high fever, headache, nausea, and vomiting, as these may indicate a serious condition requiring prompt medical consultation.

Other adverse reactions warranting medical advice include worsening pain or nasal congestion lasting more than five days in children or seven days in adults, fever persisting for more than three days, the presence of redness or swelling, or the emergence of new symptoms.

Patients with pre-existing conditions such as liver disease, heart disease, high blood pressure, thyroid disease, diabetes, glaucoma, or breathing problems (including asthma, chronic bronchitis, or emphysema) should consult a doctor before using this product. Furthermore, individuals experiencing difficulty urinating due to an enlarged prostate gland, or those taking sedatives, tranquilizers, or the blood-thinning medication warfarin, should also seek medical advice prior to use.

Drug Interactions

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

The use of this medication is also contraindicated in patients currently taking prescription Monoamine Oxidase Inhibitors (MAOIs) or those who have taken MAOIs within the past two weeks, as this may lead to serious adverse effects.

Patients should consult a healthcare professional prior to using this medication if they are concurrently taking sedatives or tranquilizers, as these may enhance the sedative effects and increase the risk of drowsiness.

Additionally, individuals taking the anticoagulant warfarin should seek medical advice before using this medication, as there may be an increased risk of bleeding.

It is advised to avoid the consumption of alcohol, sedatives, and tranquilizers while using this medication, as these substances may further increase drowsiness and impair cognitive and motor functions.

Packaging & NDC

Below are the non-prescription pack sizes of Antiflu Des (acetaminophen phenylephrine hcl chlorpheniramine maleate). 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 1 capsule taken with water every 4 hours, with a maximum of 6 capsules in a 24-hour period.

Healthcare professionals should be aware that excitability may occur, particularly in patients aged 12 to 18 years. If pain or nasal congestion worsens or persists beyond 5 days in children or 7 days in adults, it is advised to discontinue use and consult a physician.

In the event of an accidental overdose, immediate medical assistance should be sought, or contact a Poison Control Center at 1-800-222-1222. Prompt medical attention is essential for both adults and pediatric patients, even if no signs or symptoms are evident.

Geriatric Use

There is no specific geriatric use information provided in the prescribing information. The absence of recommended age considerations, dosage adjustments, safety concerns, or special precautions indicates that the data does not suggest any particular modifications or monitoring requirements for elderly patients. Healthcare providers should exercise clinical judgment when prescribing this medication to geriatric patients, considering individual patient factors and overall health status.

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 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 may not have specific information regarding dosage adjustments, special monitoring, or safety considerations outlined in the prescribing information. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment and monitoring of these patients.

Hepatic Impairment

Patients with hepatic impairment should exercise caution when using this product, which contains acetaminophen. It is critical to adhere to the maximum daily dosage of 4,000 mg, as exceeding this limit may result in severe liver damage.

Additionally, patients must avoid concomitant use of other medications that contain acetaminophen, as this can further increase the risk of hepatotoxicity. Furthermore, consumption of three or more alcoholic drinks per day while using this product is contraindicated, as it may exacerbate the potential for liver injury.

Monitoring of liver function is recommended for patients with compromised liver function who are prescribed this product. Regular assessment of liver enzymes and overall hepatic health may be necessary to ensure patient safety and to mitigate the risk of adverse effects.

Overdosage

In cases of overdosage, it is critical to recognize the potential for severe liver damage associated with excessive intake of the product.

Maximum Daily Dosage Healthcare professionals should advise patients that the maximum recommended daily dosage is 4,000 mg. Exceeding this limit within a 24-hour period significantly increases the risk of severe liver damage.

Drug Interactions The concomitant use of this product with other medications containing acetaminophen can also lead to severe liver damage. It is essential for healthcare providers to review all medications a patient is taking to prevent potential interactions that could exacerbate the risk of hepatotoxicity.

Alcohol Consumption Patients should be cautioned against the consumption of three or more alcoholic drinks daily while using this product, as this behavior further elevates the risk of severe liver damage. Healthcare professionals should assess patients' alcohol intake and provide guidance on safe consumption levels.

In the event of suspected overdosage, immediate medical attention is warranted. Monitoring liver function and implementing appropriate management strategies are crucial to mitigate the risk of serious complications.

Nonclinical Toxicology

If pregnant or breast-feeding, it is advised to consult a health professional before use. No specific non-teratogenic effects have been identified in the available data. Additionally, there are no detailed findings regarding nonclinical toxicology or animal pharmacology and toxicology provided in the current information.

Postmarketing Experience

Postmarketing experience has identified that acetaminophen may be associated with severe skin reactions and severe allergic reactions. Reported symptoms include skin reddening, blisters, rash, hives, facial swelling, asthma (wheezing), and shock. In the event of a skin or any allergic reaction, it is advised to discontinue use and seek medical attention immediately.

Healthcare professionals and patients are encouraged to report any side effects to the designated contact number, 1-305-677-0850, which is available 24 hours a day, seven days a week.

Patient Counseling

Healthcare providers should advise patients to consult a health professional if they are pregnant or breastfeeding before using this product. It is important for patients to understand the potential risks and benefits associated with its use during these periods.

Providers should emphasize the necessity of keeping this product out of reach of children to prevent accidental ingestion or misuse. Patients should be informed that safeguarding medications is a critical aspect of responsible health management.

In the event of an accidental overdose, healthcare providers must instruct patients to seek medical help immediately or contact a Poison Control Center at 1-800-222-1222. It is essential to communicate that prompt medical attention is crucial for both adults and children, even if no signs or symptoms of overdose are apparent.

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 in a dry place and ensure that the temperature does not exceed 77ºF (25ºC) to maintain its integrity and efficacy. Special handling precautions should be observed to prevent exposure to conditions that may compromise the product's quality.

Additional Clinical Information

The medication is administered orally. For adults and children aged 12 years and older, the recommended dosage is one capsule taken with water every four hours, with a maximum of six capsules 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 before use. In the event of an accidental overdose, it is crucial to seek medical assistance or contact a Poison Control Center (1-800-222-1222) immediately, as prompt medical attention is essential for both adults and children, regardless of the presence of symptoms.

Drug Information (PDF)

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

View product document (PDF)