Axim Night Time - Liquid

Description

Acetaminophen, Dextromethorphan HBr, and Doxylamine Succinate are the active ingredients in this formulation. The product is presented in a liquid dosage form, with a total volume of 12 fluid ounces (355 mL).

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 should advise patients to take the medication only as directed, adhering to the overdose warning. It is essential to measure the dosage using the provided dosage cup, which should be kept with the product for accurate measurement.

For adults and children aged 12 years and older, the recommended dosage is 30 mL every 6 hours, with a maximum limit of 4 doses within a 24-hour period. When utilizing both DayTime and NightTime products, the total combined dosage must not exceed 4 doses in a 24-hour timeframe.

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:

• Co-administration 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.

• Concurrent use with prescription monoamine oxidase inhibitors (MAOIs) or within 2 weeks of discontinuing an MAOI, as this may lead to serious drug interactions. If there is uncertainty regarding the presence of an MAOI in a prescription medication, seek advice from a healthcare professional.

• History of allergic reactions to this product or any of its ingredients, as this may result in severe allergic responses.

• Use in children for the purpose of inducing sleep, as this is not an approved indication and may pose safety risks.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen, under specific circumstances. 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 is further heightened if this product is taken concurrently with other medications containing acetaminophen or if the individual consumes three or more alcoholic drinks daily while using this product.

Acetaminophen has been associated with severe skin reactions, which may manifest as skin reddening, blisters, or rash. In the event of any 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 or seek medical help without delay, regardless of the presence of symptoms.

General precautions should be emphasized to ensure safe use of this product. Patients must not exceed the recommended dosage. Excitability may occur, particularly in children, and marked drowsiness is a potential side effect. Alcoholic beverages should be avoided, as they may exacerbate drowsiness, especially when combined with sedatives or tranquilizers. Caution is advised when driving or operating machinery due to the potential for drowsiness.

Patients should be advised to discontinue use and consult a healthcare provider if any of the following occur: pain or cough worsens or lasts longer than 7 days; fever worsens or persists for more than 3 days; redness or swelling is observed; new symptoms develop; or if a cough recurs or is accompanied by a rash or headache that lasts. These symptoms may indicate a serious condition requiring medical 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 acetaminophen 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 use. Symptoms may include skin reddening, blisters, and rash. In the event of a skin reaction, it is imperative to discontinue use and seek medical assistance immediately.

During the use of this product, excitability may occur, particularly in children, and marked drowsiness has been reported. 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 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 may indicate a serious 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

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 a prescription monoamine oxidase inhibitor (MAOI) for conditions such as depression, psychiatric disorders, or Parkinson's disease, as well as for a period of 2 weeks following the discontinuation of an MAOI. This interaction 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 substances may enhance the sedative effects of the medication, leading to increased drowsiness.

Additionally, individuals taking the anticoagulant warfarin should seek advice from a healthcare provider before using this medication, as there may be an increased risk of bleeding or other interactions.

It is important to note that the combined use of alcohol, sedatives, and tranquilizers with this medication may further increase drowsiness, necessitating caution in activities requiring alertness.

Packaging & NDC

Below are the non-prescription pack sizes of Axim 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 product. For those aged 12 years and older, the recommended dosage is 30 mL every 6 hours, with a maximum of 4 doses (30 mL each) in a 24-hour period to avoid the risk of severe liver damage.

Caution is advised as excitability may occur, particularly in children. Additionally, marked drowsiness is a potential side effect that healthcare professionals should monitor.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any adverse effects or changes in therapeutic response, given the lack of targeted data for 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 the safety of both the mother and the developing fetus or nursing infant.

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 lack of data necessitates careful clinical judgment.

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 this medication can lead to serious health complications, particularly liver damage. It is essential for healthcare professionals to recognize the potential severity of an overdose and to act promptly.

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, as symptoms may not be immediately apparent. This applies to both adults and children, underscoring the importance of vigilance even in the absence of noticeable signs or symptoms.

Timely medical attention can significantly influence the outcome of an overdose situation, making it imperative for healthcare professionals to educate patients and caregivers about the risks associated with exceeding the recommended dosage.

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. Additionally, there are no detailed findings related to nonclinical toxicology or animal pharmacology and toxicology available.

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions: severe skin reactions, which may include symptoms such as skin reddening, blisters, and rash. In the event of a skin reaction, it is advised to discontinue use and seek medical assistance immediately.

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. Additionally, patients with a history of allergic reactions to this product or any of its ingredients should be cautioned against its use.

Patients should be made aware that this product is not intended to induce sleep in children. They should be instructed to discontinue use and consult a doctor if pain or cough worsens or persists for more than seven days, if fever worsens or lasts more than three days, or if any redness or swelling occurs. Patients should also be advised to seek medical attention 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 and to be aware that excitability may occur, particularly in children. Marked drowsiness is a potential side effect, and patients should be cautioned against consuming alcoholic beverages while using this product. They should also exercise caution when driving or operating machinery, as alcohol, sedatives, and tranquilizers may enhance drowsiness.

Patients with liver disease, glaucoma, or a cough accompanied by excessive phlegm should be advised to consult a doctor before using this product. Additionally, those with breathing problems, chronic coughs related to smoking, asthma, chronic bronchitis, or emphysema should seek medical advice prior to use. Patients experiencing difficulty urinating due to an enlarged prostate gland should also consult a healthcare provider. Finally, patients taking sedatives, tranquilizers, or the blood-thinning medication warfarin should be encouraged to discuss their use of this product with a doctor or pharmacist.

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. 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 Axim Night Time - Liquid, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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