Axiv Daytime - Liquid

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 the common cold and influenza. Specifically, it alleviates minor aches and pains, headache, sore throat, fever, and cough due to minor throat and bronchial irritation.

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

Dosage and Administration

Healthcare professionals should advise patients to take the medication only as directed, with particular attention to the overdose warning. It is essential to measure the dosage using the provided dosage cup, which should be kept with the product to ensure accurate dosing.

For adults and children aged 12 years and older, the recommended dosage is 30 mL every 4 hours. Patients must not exceed 4 doses within a 24-hour period. When utilizing both DayTime and NightTime formulations, it is crucial to carefully read each label to confirm the correct dosing.

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

Contraindications

Use of this product is contraindicated in the following situations:

• Concurrent use 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.

• In patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such treatment. MAOIs are used for certain psychiatric or emotional conditions and Parkinson's disease, and their interaction with this product may lead to serious adverse effects. Verify with a healthcare professional if there is uncertainty regarding MAOI status.

• In individuals with a known history of allergic reactions to this product or any of its components, as this may result in severe allergic responses.

Warnings and Precautions

This product contains acetaminophen, which poses a risk of severe liver damage under certain conditions. Healthcare professionals should advise patients that the maximum daily dosage for adults and children over 12 years of age is 4 doses (30 mL each) within a 24-hour period. Patients must be cautioned against taking this product concurrently with other medications containing acetaminophen, as this increases the risk of overdose. Additionally, individuals who consume three or more alcoholic drinks daily while using this product are at heightened risk for liver damage.

Acetaminophen may also lead to severe skin reactions, which can manifest as skin reddening, blisters, or rash. In the event of any skin reaction, patients should be instructed to discontinue use immediately and seek medical assistance.

Patients presenting with a severe sore throat that persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, should be advised to consult a physician promptly. It is critical to emphasize that taking more than the recommended dose can result in serious health complications, including liver damage. In cases of accidental overdose, immediate professional assistance should be sought, and patients should contact a Poison Control Center without delay, as rapid medical intervention is essential for both adults and children, even in the absence of symptoms.

General precautions should be taken for patients with specific health conditions. Individuals with liver disease, a cough associated with excessive phlegm, or a persistent or chronic cough due to smoking, asthma, or emphysema should consult a physician prior to use. Furthermore, patients taking the anticoagulant warfarin should seek advice from a healthcare provider or pharmacist before using this product.

Patients should be instructed to stop taking the product and contact their doctor if they experience nervousness, dizziness, or sleeplessness; if pain or cough worsens or persists beyond 7 days; if fever worsens or lasts more than 3 days; if redness or swelling occurs; if new symptoms develop; or if a cough recurs alongside a rash or headache that lasts. These symptoms may indicate a serious underlying condition that requires medical evaluation.

Side Effects

Severe liver damage may occur in patients who exceed the maximum daily dosage of this product, which is 4 doses (30 mL each) within a 24-hour period, particularly in adults and children over 12 years of age. The risk of liver damage is further increased when this product is taken in conjunction with other medications containing acetaminophen or when consumed by adults who regularly consume 3 or more alcoholic drinks daily.

Patients should be aware that acetaminophen may cause severe skin reactions, which can manifest as skin reddening, blisters, or rash. In the event of a skin reaction, it is imperative to discontinue use and seek medical assistance immediately.

In cases of severe sore throat that persists for more than 2 days or is accompanied by fever, headache, rash, nausea, or vomiting, patients are advised to consult a healthcare professional promptly.

This product should not be used in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription. Patients should verify the presence of acetaminophen in any other medications they are taking by consulting a doctor or pharmacist. Additionally, this product is contraindicated for individuals currently taking a prescription monoamine oxidase inhibitor (MAOI) or those who have taken an MAOI within the past 2 weeks. Patients with a history of allergic reactions to this product or any of its ingredients should also refrain from use.

Patients with liver disease, a cough that produces excessive phlegm, or a persistent or chronic cough associated with smoking, asthma, or emphysema should consult a doctor before using this product. Furthermore, individuals taking the blood-thinning medication warfarin should seek advice from a healthcare professional prior to use.

While using this product, patients must adhere strictly to the recommended dosage to avoid overdose. They should discontinue use and consult a doctor if they experience symptoms such as nervousness, dizziness, sleeplessness, worsening pain or cough lasting more than 7 days, fever lasting more than 3 days, redness or swelling, the emergence of new symptoms, or if a cough recurs with a rash or headache that persists. These symptoms may indicate a serious condition.

Taking more than the recommended dose can lead to serious health complications, including liver damage. In the event of an accidental overdose, it is crucial to seek professional medical assistance 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 initially apparent.

Drug Interactions

Patients taking acetaminophen should consult with a healthcare professional prior to use if they are concurrently using warfarin, a blood-thinning medication. The combination may lead to potential interactions that could affect the efficacy and safety of warfarin therapy.

No additional drug interactions or laboratory test interactions have been identified for acetaminophen. Therefore, routine monitoring or dosage adjustments are not indicated beyond the aforementioned consideration with warfarin.

Packaging & NDC

Below are the non-prescription pack sizes of Axiv Daytime - Liquid (acetaminophen, dextromethorphan hydrobromide). 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 30 mL every 4 hours, with a maximum of 4 doses within a 24-hour period. Caution is advised to ensure that the dosage does not exceed the recommended limits.

Geriatric Use

There is no specific information 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 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 drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the absence of guidance 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 consult a healthcare professional prior to using this product, as it contains acetaminophen, which can pose significant risks to individuals with liver disease.

Severe liver damage may occur if adults and children over 12 years of age exceed the maximum daily dosage of 4 doses (30 mL each) within a 24-hour period. Additionally, the risk of liver damage increases if this product is taken concurrently with other medications containing acetaminophen or if the adult consumes 3 or more alcoholic drinks daily while using this product.

Patients are advised that taking more than the recommended dose can lead to serious health complications, including liver damage. In the event of an accidental overdose, it is imperative to seek professional medical assistance or contact a Poison Control Center immediately. Prompt medical attention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Overdosage

Taking more than the recommended dose of the medication can lead to serious health complications, including potential liver damage. It is imperative that healthcare professionals remain vigilant regarding the risks associated with overdosage.

In the event of an accidental overdose, immediate professional assistance should be sought. Healthcare providers are advised to contact a Poison Control Center without delay. Prompt medical intervention is crucial, as symptoms may not be immediately apparent. This applies to both adults and children, underscoring the importance of acting swiftly even in the absence of noticeable signs or symptoms.

Healthcare professionals should ensure that patients and caregivers are aware of these risks and the necessary steps to take in the case of an overdose, reinforcing the importance of adherence to prescribed dosages.

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: severe skin reactions, which may manifest as skin reddening, blisters, and rash. In the event of a skin reaction, it is advised to discontinue use and seek medical assistance promptly.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. 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 whether a medication contains acetaminophen, they should be encouraged to consult a doctor or pharmacist.

It is crucial to inform patients that this product should not be used if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have taken one within the past two weeks. Patients should be advised to check with their healthcare provider if they are unsure whether their prescription includes an MAOI.

Patients with a history of allergic reactions to this product or any of its ingredients should be cautioned against its use. Healthcare providers should instruct patients to discontinue use and seek medical advice if they experience symptoms such as nervousness, dizziness, or sleeplessness. Additionally, patients should be advised to stop using the product and consult a doctor if their pain or cough worsens or persists for more than seven days, if fever worsens or lasts more than three days, or if they notice any redness or swelling.

Patients should also be informed to seek medical attention if new symptoms arise or if a cough returns, particularly if accompanied by a rash or persistent headache, as these may indicate a serious condition. It is important to emphasize that patients should not exceed the recommended dosage and to be aware of the overdose warning.

Healthcare providers should recommend that patients consult a doctor before using this product if they have liver disease, a cough that produces excessive phlegm, or a persistent or chronic cough associated with smoking, asthma, or emphysema. Furthermore, patients taking the blood-thinning medication warfarin should be advised to speak with their doctor or pharmacist prior to using this product.

Storage and Handling

The product is supplied in a configuration that ensures tamper evidence; it should not be used if the shrink band is missing or broken.

For optimal storage, the product must be kept at room temperature, specifically within the range of 15 to 30°C (59 to 86°F). It is important to avoid refrigeration to maintain the integrity of the product.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. No further information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

Drug Information (PDF)

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

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