Axiv Night Time - Liquid

Description

No description information is available for the drug.

Uses and Indications

This drug is indicated for the temporary relief of symptoms associated with the common cold and influenza. Specifically, it alleviates sore throat, minor aches and pains, runny nose, sneezing, headache, 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 are advised to administer the medication strictly as directed, adhering to the overdose warning. The dosage should be measured using the dosage cup provided with the product, which must be kept with the product at all times.

For adults and children aged 12 years and older, the recommended dosage is 30 mL every 6 hours. It is important to note that the total number of doses should not exceed 4 doses within a 24-hour period. When utilizing both DayTime and NightTime formulations, the combined total of doses from both products must also be limited to 4 doses per 24 hours.

This 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, as this may lead to serious drug interactions. If there is uncertainty regarding the presence of an MAOI in a prescription, seek advice from a healthcare professional.

• In individuals with a known history of allergic reactions to this product or any of its components, to prevent potential severe allergic responses.

• For use in children to induce sleep, as this is not an approved indication and may pose safety risks.

Warnings and Precautions

This product contains acetaminophen, which poses a risk of severe liver damage under certain conditions. Adults and children over 12 years of age should not exceed 4 doses (30 mL each) within a 24-hour period, as this represents the maximum daily amount. The risk of liver damage increases if acetaminophen is taken concurrently with other medications containing acetaminophen or if the individual consumes three or more alcoholic drinks daily while using this product.

Severe skin reactions have been associated with acetaminophen use. Symptoms may include skin reddening, blisters, and rash. In the event of a skin reaction, it is imperative to discontinue use immediately and seek medical assistance.

Healthcare professionals should advise patients to consult a doctor promptly if a sore throat is severe, persists for more than two days, or is accompanied or followed by fever, headache, rash, nausea, or vomiting.

Overdose of acetaminophen can lead to serious health complications, including liver damage. In cases of suspected overdose, immediate medical attention is crucial. Patients should be instructed to contact a Poison Control Center without delay, regardless of whether signs or symptoms are present.

General precautions should be taken prior to use. Patients should be advised to consult a healthcare provider if they have a history of liver disease, glaucoma, a cough associated with excessive phlegm, or any breathing problems, including chronic cough related to smoking, asthma, chronic bronchitis, or emphysema. Additionally, individuals experiencing difficulty urinating due to an enlarged prostate gland should seek medical advice before use.

Patients should also inform their doctor or pharmacist if they are currently taking sedatives, tranquilizers, or the blood-thinning medication warfarin, as these may interact with acetaminophen.

Patients should discontinue use and contact a healthcare professional if pain or cough worsens or persists for more than 7 days, if fever worsens or lasts more than 3 days, if redness or swelling occurs, if new symptoms arise, or if a cough recurs alongside a rash or headache that lasts. These symptoms may indicate a serious condition requiring further evaluation.

Side Effects

Severe liver damage may occur in patients who exceed the maximum daily dosage of 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 heightened when this product is taken in conjunction with other medications containing acetaminophen or when patients consume three 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.

While using this product, excitability may occur, particularly in children, and marked drowsiness is also a possibility. Patients are advised to avoid alcoholic beverages, as well as sedatives and tranquilizers, which may exacerbate drowsiness. Caution is recommended when driving a motor vehicle or operating machinery.

Patients should discontinue use and consult a healthcare professional if pain or cough worsens or persists for more than 7 days, if fever worsens or lasts longer 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 may indicate a serious underlying condition.

Additionally, taking more than the recommended dose can lead to serious health complications, including liver damage. In cases of overdose, it is crucial 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 signs or symptoms.

Drug Interactions

There are currently no documented drug interactions associated with the use of this medication. Additionally, there is no information available regarding 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 Axiv Night Time - Liquid (acetaminophen, dextromethorphan hydrobromide, doxylamine succinate). 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 6 hours.

Healthcare professionals should be aware that excitability may occur, particularly in children. In the event of an overdose, it is crucial to seek quick medical attention for pediatric patients, even if no signs or symptoms are immediately apparent.

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. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is important to evaluate the potential risks and benefits associated with the use of this drug during pregnancy and lactation. Healthcare providers should consider the available data and individual patient circumstances when advising on the use of this medication in these populations.

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 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, which contains acetaminophen. Severe liver damage may occur if adults and children over 12 years of age exceed the maximum daily amount 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 patient consumes three or more alcoholic drinks daily while using this product.

It is advised that patients with a history of liver disease consult a healthcare professional prior to use. Taking more than the recommended dose can lead to serious health complications, including liver damage. In the event of an overdose, immediate medical assistance should be sought, or the patient should contact a Poison Control Center without delay. Prompt medical attention is crucial for both adults and children, even if no signs or symptoms of overdose are apparent.

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 overdose, immediate medical assistance should be sought. Healthcare providers are advised to contact a Poison Control Center without delay. Quick intervention is crucial for both adults and children, even in the absence of noticeable signs or symptoms of overdose. Prompt medical evaluation and management can significantly mitigate the risks associated with overdosage and improve patient outcomes.

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 several adverse reactions associated with the use of acetaminophen. Notably, severe skin reactions have been reported, which include symptoms such as skin reddening, blisters, and rash. In the event of a skin reaction, it is advised that the use of acetaminophen be discontinued immediately, and medical assistance should be sought without delay.

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 also 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 discontinue use 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 notice any redness or swelling. They should also be advised to stop use and 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 be reminded to adhere strictly to the recommended dosage. They should be made aware that excitability may occur, particularly in children, and that marked drowsiness is a possible side effect. Patients should be advised to avoid alcoholic beverages while using this product, as well as to exercise caution when driving or operating machinery due to the potential for increased drowsiness, especially when combined with alcohol, sedatives, or tranquilizers.

Patients with liver disease, glaucoma, a cough accompanied by excessive phlegm, or chronic respiratory conditions such as asthma, chronic bronchitis, or emphysema should be encouraged to consult their healthcare provider before using this product. Additionally, those experiencing urinary difficulties due to an enlarged prostate gland, as well as patients taking sedatives, tranquilizers, or the blood-thinning medication warfarin, should seek advice from a doctor or pharmacist prior to use.

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 89°F). It is imperative that the product is not refrigerated to maintain its integrity and efficacy.

Additional Clinical Information

The medication is administered orally, with a recommended dosage of 30 mL every 6 hours for adults and children aged 12 years and older. It is contraindicated for use in children under 12 years. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. No additional information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

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

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