Sanaflu Xtra

Description

No description information is available for the drug.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains, including headaches. It is also indicated for the alleviation of symptoms associated with upper respiratory allergies, such as runny nose, sneezing, nasal congestion, and itchy, watery eyes due to hay fever or other allergic conditions. Additionally, this drug provides temporary relief from itching of the nose or throat and cough resulting from minor throat and bronchial irritation, which may occur with the common cold or exposure to inhaled irritants. Furthermore, it is indicated for the temporary reduction of fever.

There are no teratogenic or nonteratogenic effects mentioned in the available data.

Dosage and Administration

Adults and children 12 years of age and older are advised to take 2 capsules every 4 hours as needed. The maximum dosage should not exceed 12 capsules within a 24-hour period.

For children under 12 years of age, it is recommended to consult a healthcare professional for appropriate dosing guidance.

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 there is uncertainty regarding the presence of acetaminophen in other medications, consultation with a healthcare professional is advised.

• Concurrent use with prescription monoamine oxidase inhibitors (MAOIs), which are utilized for the treatment of depression, psychiatric or emotional conditions, or Parkinson's disease, as well as for a period of 2 weeks following the discontinuation of an MAOI. If there is uncertainty about the presence of an MAOI in a prescription medication, a healthcare professional should be consulted prior to use.

• Use beyond the directed dosage is contraindicated.

• Consumption of alcoholic beverages should be avoided while using 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 avoid exceeding 4,000 mg of acetaminophen within a 24-hour period. Additionally, patients should not use this product in conjunction with other medications containing acetaminophen, nor should they consume three or more alcoholic drinks daily while using this product.

It is imperative that this product not be used alongside any other drug containing acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in other medications, patients should consult a healthcare provider or pharmacist for clarification.

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 unsure whether their prescription includes an MAOI, they should seek guidance from a healthcare professional.

In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay. Prompt medical attention is crucial, even if the patient does not exhibit any signs or symptoms of overdose.

Patients should discontinue use and consult a healthcare provider if any of the following occur: pain, cough, or nasal congestion worsens or persists beyond seven days; fever worsens or lasts more than three days; redness or swelling is observed; new symptoms develop; or if a cough recurs alongside a rash or headache that persists. These symptoms may indicate a serious condition. Additionally, if patients experience nervousness, dizziness, or sleeplessness, they should stop taking the product and seek medical advice.

Side Effects

Severe liver damage may occur in patients taking this product containing acetaminophen if they exceed 4,000 mg in 24 hours, use other medications containing acetaminophen, or consume three or more alcoholic drinks daily while using this product.

Common adverse reactions associated with the use of this product include marked drowsiness, which may be exacerbated by the consumption of alcohol, sedatives, or tranquilizers. Patients are advised to avoid alcoholic beverages and to exercise caution when driving or operating machinery due to the potential for increased drowsiness. Additionally, excitability may occur, particularly in children.

Patients should discontinue use and consult a healthcare professional if pain, cough, or nasal congestion worsens or persists for more than 7 days, if fever worsens or lasts more than 3 days, or if redness or swelling is observed. New symptoms, a returning cough, or a cough accompanied by a rash or headache that lasts may indicate a serious condition and warrant immediate medical attention. Other concerning symptoms include nervousness, dizziness, or sleeplessness.

Before using this product, patients should seek medical advice if they have a history of liver disease, breathing problems such as emphysema or chronic bronchitis, glaucoma, heart disease, high blood pressure, difficulty urinating due to prostate enlargement, persistent or chronic cough (such as that associated with smoking, asthma, or emphysema), cough with excessive phlegm, thyroid disease, or diabetes.

Patients taking the blood-thinning medication warfarin or those using sedatives or tranquilizers should also consult a healthcare professional prior to use.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there are no known 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 Sanaflu Xtra (acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride). 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 and adults aged 12 years and older, the recommended dosage is 2 capsules every 4 hours, with a maximum of 12 capsules in a 24-hour period.

Caution is advised as the medication may cause excitability, particularly in children. It is important to keep this medication out of reach of children to prevent accidental ingestion.

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 safe use during pregnancy and lactation.

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 considering the use of this medication during lactation.

Renal Impairment

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment should exercise caution when using this product, as it contains acetaminophen. Severe liver damage may occur if the total daily dosage exceeds 4,000 mg of acetaminophen, particularly if taken in conjunction with other medications containing acetaminophen or if the patient consumes three or more alcoholic drinks daily while using this product.

It is recommended that patients with liver disease consult a healthcare professional prior to use to assess the appropriateness of this product and to discuss potential risks associated with acetaminophen use in the context of their liver function. Monitoring of liver function may be warranted in these patients to prevent potential adverse effects.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Prompt medical attention is critical, even in the absence of noticeable signs or symptoms. Healthcare professionals should be aware that early intervention can significantly impact patient outcomes in cases of overdosage.

Monitoring and supportive care may be necessary, depending on the specific circumstances and the substance involved. It is essential to assess the patient's condition thoroughly and implement appropriate management strategies as dictated by clinical guidelines and the nature of the overdose.

Nonclinical Toxicology

No teratogenic effects have been observed in nonclinical studies. Additionally, there are no reported non-teratogenic effects. The available data do not provide any details regarding nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified a range of adverse reactions reported voluntarily or through surveillance programs. These include allergic reactions, such as anaphylaxis, and various skin reactions, including rash, urticaria, and pruritus. Gastrointestinal reactions have also been noted, with reports of nausea and vomiting. Hepatic reactions, characterized by elevated liver enzymes, and renal reactions, including acute kidney injury, have been documented. Cardiovascular reactions, such as palpitations and hypertension, as well as neurological reactions, including dizziness and drowsiness, have been observed. Additionally, respiratory reactions, including bronchospasm and difficulty breathing, have been reported.

Further safety updates from postmarketing experience indicate instances of misuse and abuse of the product, particularly among populations with a history of substance use disorders. Serious skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have also been associated with the use of this product.

Monitoring for these adverse reactions is recommended, and healthcare providers should remain vigilant in assessing patients for any signs of these conditions.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center in the event of an overdose, emphasizing that prompt medical attention is critical even if no signs or symptoms are apparent.

Patients should be informed not to use this product in conjunction with any other medications containing acetaminophen, whether prescription or nonprescription. If patients are uncertain about the presence of acetaminophen in their medications, they should be encouraged to consult a doctor or pharmacist.

It is important to instruct patients not to use this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have stopped taking an MAOI within the past two weeks. Patients should be advised to verify with a healthcare professional if they are unsure whether their prescription includes an MAOI.

Patients should be counseled to discontinue use and consult a doctor if their pain, cough, or nasal congestion worsens or persists for more than 7 days. Additionally, they should seek medical advice if their fever worsens or lasts longer than 3 days, if they notice any redness or swelling, or if new symptoms arise. Patients should also be informed to stop use and consult a doctor if a cough recurs or is accompanied by a rash or headache that persists, as these may indicate a serious condition.

Healthcare providers should inform patients that nervousness, dizziness, or sleeplessness may occur, and they should not exceed the recommended dosage. Patients should be made aware that the product may cause marked drowsiness, and that the effects may be intensified by alcohol, sedatives, or tranquilizers. Therefore, patients should be advised to avoid alcoholic beverages and to exercise caution when driving or operating machinery.

Particular attention should be given to children, as the product may cause excitability in this population. Patients with specific health conditions should be encouraged to consult a doctor before use, including those with liver disease, breathing problems (such as emphysema or chronic bronchitis), glaucoma, heart disease, high blood pressure, difficulty urinating due to prostate enlargement, persistent or chronic cough (such as that associated with smoking, asthma, or emphysema), cough accompanied by excessive phlegm, thyroid disease, or diabetes.

Finally, patients should be advised to consult a doctor or pharmacist if they are taking the blood-thinning medication warfarin or if they are using sedatives or tranquilizers.

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 room temperature, ensuring that it is kept in a dry place to maintain its integrity and effectiveness. Proper storage conditions are crucial for preserving the quality of the product throughout its shelf life.

Additional Clinical Information

Adults and children aged 12 years and older are advised to take 2 capsules every 4 hours, with a maximum of 12 capsules in a 24-hour period. For children under 12 years of age, consultation with a doctor is recommended prior to administration.

Clinicians should counsel patients to seek advice from a health professional if they are pregnant or breastfeeding. It is important to keep the medication out of reach of children. In the event of an overdose, patients should obtain medical help or contact a Poison Control Center immediately, as prompt medical attention is crucial, even if no signs or symptoms are present.

Drug Information (PDF)

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

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