Axiv Nighttime

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 cough due to minor throat and bronchial irritation, sore throat, headache, minor aches and pains, fever, as well as runny nose and sneezing.

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

Dosage and Administration

Patients should adhere strictly to the prescribed dosage to avoid the risk of overdose. The maximum recommended dosage is 8 Softgels within a 24-hour period.

For adults and children aged 12 years and older, the recommended dosage is 2 Softgels taken with water every 6 hours as needed.

For children aged 4 to under 12 years, it is advised to consult a healthcare professional before administration.

The use of this product is not recommended for children under 4 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, as this may lead to serious drug interactions. If there is uncertainty regarding the presence of an MAOI in a prescription, seek guidance from a healthcare professional.

• In individuals with a known history of allergic reactions to this product or any of its components.

• For the purpose of inducing sleep in children, as this use is not recommended.

Warnings and Precautions

This product contains acetaminophen, which poses a risk of severe liver damage if the following conditions are met: exceeding 8 Softgels within a 24-hour period, using other medications that also contain acetaminophen, or consuming 3 or more alcoholic drinks daily while using this product.

Acetaminophen may also lead to 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 immediately and seek medical assistance. Additionally, if a sore throat is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, prompt consultation with a healthcare provider is advised.

Healthcare professionals should exercise caution and advise patients to consult a doctor prior to use if they have any of the following conditions: liver disease, glaucoma, a cough associated with excessive phlegm, breathing problems or chronic cough related to smoking, asthma, chronic bronchitis, or emphysema, or difficulty urinating due to an enlarged prostate gland. Furthermore, patients should be advised to seek guidance from a doctor or pharmacist if they are currently taking the anticoagulant warfarin or any sedatives or tranquilizers.

In the event of an overdose, immediate medical attention is crucial. Patients should be instructed to contact a Poison Control Center or seek emergency medical help without delay, as timely intervention is essential for both adults and children, even in the absence of noticeable symptoms.

Patients should discontinue use and consult a healthcare provider if any of the following occur: worsening pain or cough lasting more than 7 days, fever that worsens or persists for more than 3 days, presence of redness or swelling, emergence of new symptoms, or recurrence of cough accompanied by rash or headache lasting longer than expected. These symptoms may indicate a serious underlying condition that requires further evaluation.

Side Effects

Severe liver damage may occur in patients who exceed the maximum daily dosage of 8 Softgels within a 24-hour period, take this product in conjunction with other medications containing acetaminophen, or consume 3 or more alcoholic drinks daily while using this product.

Patients should be aware of the potential for severe skin reactions associated with acetaminophen, which may 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.

A sore throat warning is advised; if a sore throat is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, patients should consult a healthcare professional promptly.

This product should not be used in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription. Patients are encouraged to consult a doctor or pharmacist if uncertain about the presence of acetaminophen in other medications. Additionally, this product should not be used by individuals currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of stopping such medication. Those with a history of allergic reactions to this product or any of its ingredients, as well as individuals seeking to use it to induce sleep in children, should also refrain from use.

Patients are advised to consult a doctor before using this product if they have liver disease, glaucoma, a cough associated with excessive phlegm, a chronic cough related to smoking, asthma, chronic bronchitis, emphysema, or difficulty urinating due to an enlarged prostate gland. Furthermore, individuals taking the blood-thinning medication warfarin or those on sedatives or tranquilizers should seek guidance from a healthcare professional prior to use.

While using this product, patients must adhere to the directed dosage. Excitability may occur, particularly in children, and marked drowsiness is a potential side effect. Patients should avoid alcoholic beverages, as well as be cautious when driving or operating machinery, since alcohol, sedatives, and tranquilizers may exacerbate drowsiness.

Patients should discontinue use and consult a doctor if pain or cough worsens or persists beyond 7 days, if fever worsens or lasts more than 3 days, if redness or swelling is observed, if new symptoms arise, or if a cough recurs with a rash or headache that lasts. These symptoms could indicate a serious condition.

In the event of an overdose, it is critical for patients to seek medical help or contact a Poison Control Center immediately. Prompt medical attention is essential for both adults and children, even if no signs or symptoms are initially apparent.

Drug Interactions

Acetaminophen co-administration with other products containing acetaminophen or the consumption of three or more alcoholic beverages daily may elevate the risk of severe liver damage. It is advisable to monitor liver function closely in patients who are using multiple acetaminophen-containing products or who consume alcohol regularly.

Dextromethorphan has the potential to enhance drowsiness when taken concurrently with alcohol, sedatives, or tranquilizers. Patients should be advised to exercise caution when engaging in activities that require alertness, such as driving or operating machinery, and to consider dosage adjustments or alternative therapies if sedation becomes problematic.

Packaging & NDC

Below are the non-prescription pack sizes of Axiv Nighttime (acetaminophen, dextromethorphan hydrobromide, doxylamine succinate). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 4 years of age should not use this medication. For children aged 4 to under 12 years, it is advised to consult a doctor prior to use.

In adolescents and adults aged 12 years and older, the recommended dosage is 2 Softgels taken with water every 6 hours, with a maximum of 8 Softgels in a 24-hour period.

Healthcare professionals should be aware that excitability may occur, particularly in children, and marked drowsiness is a potential side effect.

Geriatric Use

There is no specific information regarding the use of AXIV NightTime Cold & Flu in geriatric patients. The prescribing information does not provide guidance on dosage adjustments, safety concerns, or special precautions for elderly patients. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients, considering the lack of data on its effects and safety profile in this population. Monitoring for potential adverse effects may be warranted in elderly patients due to their unique physiological characteristics and potential for polypharmacy.

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 the safety of both the mother and the developing fetus.

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 have not been specifically studied in relation to dosage adjustments, special monitoring, or safety considerations. Consequently, there is no available information regarding the use of this medication in individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to patients with renal impairment.

Hepatic Impairment

Patients with hepatic impairment should exercise caution when using this product, which contains acetaminophen. Severe liver damage may occur if patients exceed the maximum daily dosage of 8 Softgels within a 24-hour period. Additionally, patients should avoid concomitant use with other medications containing acetaminophen, as this may further increase the risk of liver injury.

It is also advised that patients with compromised liver function refrain from consuming 3 or more alcoholic drinks daily while using this product, as alcohol can exacerbate the potential for liver damage.

Before initiating treatment, patients with a history of liver disease should consult a healthcare professional to assess the appropriateness of this product for their condition. Regular monitoring of liver function may be warranted in these patients to ensure safety and efficacy during treatment.

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 intervention is crucial for both adults and children, even in the absence of observable signs or symptoms.

Healthcare professionals are advised to remain vigilant and proactive in managing potential overdose situations. Early recognition and treatment can significantly impact patient outcomes. Therefore, it is essential to ensure that patients and caregivers are informed about the importance of rapid response in the case of suspected overdose.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to 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. Reported symptoms of these reactions include skin reddening, blisters, and rash. In the event of a skin reaction, it is advised to discontinue use immediately and seek medical assistance.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. Patients should be instructed 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 important 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 should be cautioned against using this product if they have a history of allergic reactions to it or any of its ingredients. Additionally, it should not be used as a sleep aid for children.

Patients should be instructed to stop using the product and seek medical advice if their pain or cough worsens or persists for more than seven days, if their fever worsens or lasts more than three days, or if they experience redness or swelling. They should also be advised to consult a doctor if new symptoms arise or if a cough returns with a rash or headache that lasts, as these may indicate a serious condition.

When using this product, patients should adhere strictly to the recommended dosage and be aware that excitability may occur, particularly in children. Marked drowsiness is also a potential side effect, and patients should be cautioned against consuming alcoholic beverages while using this product. They should exercise caution when driving or operating machinery, as alcohol, sedatives, and tranquilizers may enhance drowsiness.

Patients with liver disease, glaucoma, a cough accompanied by excessive phlegm, or chronic respiratory conditions such as asthma, chronic bronchitis, or emphysema should be advised to consult a doctor before using this product. Additionally, those experiencing difficulty urinating due to an enlarged prostate gland, or those taking the blood-thinning medication warfarin, should also seek guidance from a healthcare provider or pharmacist prior to use.

Storage and Handling

The product is supplied in a tamper-evident carton. It is essential to refrain from using the product if the carton is open or if the blister is compromised.

For optimal storage, the product should be maintained at a temperature range of 20° to 25°C (68° to 77°F). Proper handling and storage conditions are crucial to ensure the integrity and efficacy of the product.

Additional Clinical Information

Patients aged 12 years and older are advised to take 2 Softgels with water every 6 hours. For children aged 4 to under 12 years, consultation with a doctor is recommended, while the product should not be used in children under 4 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 product out of the reach of children. No further information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

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

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