Axim Daytime - Liquid

Description

Acetaminophen and Dextromethorphan HBr are the active ingredients in this formulation, which is presented in a liquid dosage form of 12 fluid ounces (355 mL). This product serves multiple therapeutic purposes, functioning as a pain reliever, fever reducer, cough suppressant, and nasal decongestant. It is designed to provide relief without causing drowsiness. It is important to note that this product is not manufactured or distributed by The Procter & Gamble Company, which holds the registered trademarks Vicks® and DayQuil®.

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

The medication should be taken 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. It is important not to exceed 4 doses within a 24-hour period. When utilizing both DayTime and NightTime formulations, healthcare professionals should advise patients to carefully read each label to confirm the correct dosing.

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:

• 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) or within 2 weeks of discontinuing an MAOI. This includes certain medications prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. Patients should verify with a healthcare professional if their current medications include an MAOI.

• History of allergic reactions to this product or any of its ingredients, as this may lead to severe adverse reactions.

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. Should any of these symptoms occur, patients must discontinue use immediately and seek medical assistance.

In cases of severe sore throat that persists for more than two days or is accompanied by fever, headache, rash, nausea, or vomiting, patients should be advised to consult a physician promptly. Overdosing on acetaminophen can result in serious health complications, including liver damage. In the event of an accidental overdose, it is imperative to seek professional medical help or contact a Poison Control Center without delay, as rapid medical intervention is crucial for both adults and children, even in the absence of noticeable symptoms.

General precautions should be taken when considering the use of this product. Patients should be instructed to consult a healthcare provider prior to use if they have liver disease, a cough associated with excessive phlegm, or a persistent or chronic cough due to smoking, asthma, or emphysema. Furthermore, individuals taking the anticoagulant warfarin should seek advice from a doctor or pharmacist before using this product.

Patients must be informed to stop taking the product and contact their healthcare provider if they experience nervousness, dizziness, or sleeplessness; if pain or cough worsens or persists beyond seven days; if fever worsens or lasts more than three 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 underlying condition, necessitating further 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 for 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 an adult consumes 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.

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

Patients should also discontinue use and consult a doctor if they experience symptoms such as nervousness, dizziness, or sleeplessness; if pain or cough worsens or lasts longer than seven days; if fever worsens or lasts more than three days; if redness or swelling occurs; if new symptoms arise; or if a cough recurs or is accompanied by a rash or headache that persists. 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 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 in the absence of noticeable signs or symptoms.

Drug Interactions

Concurrent use of this medication with any other drug 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), which includes certain medications prescribed for depression, psychiatric disorders, or Parkinson's disease. Additionally, it should not be used for at least 2 weeks following the discontinuation of an MAOI to avoid serious interactions.

Patients taking the anticoagulant warfarin should consult a healthcare professional, such as a doctor or pharmacist, prior to using this medication. Monitoring of coagulation parameters may be warranted to ensure safety and efficacy.

Packaging & NDC

Below are the non-prescription pack sizes of Axim 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 daily limit of 4 doses (30 mL each) within a 24-hour period. Caution is advised to ensure that the maximum daily amount is not exceeded in this age group.

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. It is important to assess the potential risks and benefits, as well as any available data regarding fetal outcomes and lactation. Healthcare providers can offer guidance tailored to individual circumstances, ensuring the safety of both the patient and the developing fetus or nursing infant.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data on the excretion of this drug 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.

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 4 doses (30 mL each) within a 24-hour period, which is the maximum daily amount for this product. 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 with a history of liver disease are advised to consult a healthcare professional prior to use. It is crucial to adhere to the recommended dosage to avoid the risk of overdose, which could lead to serious health complications, including liver damage. In the event of an accidental overdose, immediate medical attention is essential. Patients should seek professional assistance or contact a Poison Control Center without delay, even if no signs or symptoms are present, as prompt intervention is critical for both adults and children.

Overdosage

In the event of an overdose, defined as the ingestion of more than the recommended dose, serious health complications may arise, including potential liver damage.

Recommended Actions In cases of accidental overdose, it is imperative to seek professional medical assistance immediately. Healthcare professionals should be contacted, or a Poison Control Center should be reached without delay.

Symptoms and Management Prompt medical attention is crucial for both adults and children, even in the absence of noticeable signs or symptoms. Early intervention can significantly mitigate the risks associated with overdose 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. 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 present 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 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. They should be instructed to stop using the product and seek medical advice if they experience symptoms such as nervousness, dizziness, or sleeplessness. Additionally, patients should be advised to discontinue use 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 or occurs alongside a rash or headache that lasts, as these may indicate a serious condition. It is essential to emphasize that patients should not exceed the recommended dose while using this product.

Healthcare providers should recommend that patients consult a doctor before using this product if they have liver disease, a cough accompanied by 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 a 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 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 healthcare 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 Daytime - Liquid, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)