Axim Daytime - Night Time 48 Softgels, Axim Daytime - Night Time 72 Softgels

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 nasal congestion, cough due to minor throat and bronchial irritation, sore throat, headache, minor aches and pains, and fever.

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

Dosage and Administration

Patients should adhere strictly to the prescribed dosage to avoid the risk of overdose. The maximum allowable 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 4 hours as needed.

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

The product is not recommended for use in 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 there is uncertainty regarding the presence of acetaminophen in other medications, consultation with a healthcare professional is advised.

• In patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such treatment. MAOIs are commonly prescribed for depression, psychiatric, or emotional conditions, as well as for Parkinson's disease. If there is uncertainty about the presence of an MAOI in a prescription, a healthcare professional should be consulted prior to use.

• In individuals with a history of allergic reactions to this product or any of its ingredients, as this may lead to severe allergic responses.

Warnings and Precautions

This product contains acetaminophen, which poses a risk of severe liver damage if the following conditions are met: exceeding 4,000 mg of acetaminophen within a 24-hour period, concurrent use with other medications containing acetaminophen, or consumption of three or more alcoholic beverages daily while using this product.

Allergy Alert Acetaminophen may lead to severe skin reactions. Symptoms indicative of such reactions include skin reddening, blisters, and rash. Should any of these symptoms occur, it is imperative to discontinue use immediately and seek medical assistance.

Sore Throat Warning In cases of severe sore throat that persists for more than two days, or if accompanied or followed by fever, headache, rash, nausea, or vomiting, it is essential to consult a healthcare professional promptly.

General Precautions Prior to use, individuals should consult a healthcare provider if they have any of the following conditions: liver disease, heart disease, high blood pressure, diabetes, thyroid disease, difficulty urinating due to an enlarged prostate gland, a cough that produces excessive phlegm, or a persistent or chronic cough associated with smoking, asthma, or emphysema. Additionally, it is advisable to seek guidance from a doctor or pharmacist if taking the anticoagulant warfarin.

Emergency Medical Help In the event of an accidental overdose, immediate professional assistance should be sought, or a poison control center should be contacted without delay.

Discontinuation and Consultation Patients should stop using this product and consult a healthcare provider if they experience any of the following: increased nervousness, dizziness, or sleeplessness; worsening pain or cough lasting more than seven days; fever that worsens or persists beyond three days; presence of redness or swelling; emergence of new symptoms; or recurrence of cough accompanied by rash or headache lasting. These symptoms may indicate a serious underlying condition that requires medical evaluation.

Side Effects

Severe liver damage may occur in patients who exceed 4,000 mg of acetaminophen within a 24-hour period, use other medications containing acetaminophen concurrently, or 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. 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.

Patients are advised to stop use and consult a healthcare professional if they experience nervousness, dizziness, or sleeplessness. Additionally, if pain or cough worsens or persists beyond 7 days, or if fever worsens or lasts more than 3 days, medical advice should be sought. The presence of redness or swelling, the emergence of new symptoms, or a cough that recurs or is accompanied by a rash or headache that lasts may indicate a serious condition requiring prompt medical evaluation.

Drug Interactions

Acetaminophen has several important drug interactions that should be considered to ensure patient safety.

Acetaminophen Interactions Acetaminophen may significantly increase the risk of severe liver damage when used concurrently with other medications containing acetaminophen or when consumed with three or more alcoholic beverages daily. Therefore, patients should be advised to avoid combining acetaminophen with other acetaminophen-containing products and to limit alcohol intake.

The use of acetaminophen is contraindicated in patients taking prescription monoamine oxidase inhibitors (MAOIs) and for a period of two weeks following the discontinuation of MAOIs. This contraindication is critical to prevent potential adverse effects.

Patients who are on warfarin therapy should seek guidance from a healthcare professional, such as a doctor or pharmacist, prior to using acetaminophen, as there may be potential interactions that could affect anticoagulation control.

Doxylamine Interactions Doxylamine may enhance drowsiness when taken in conjunction with alcohol, sedatives, or tranquilizers. Patients should be cautioned about the additive sedative effects and advised to avoid such combinations to prevent excessive sedation.

No additional drug interactions or laboratory test interactions have been identified for the medications discussed.

Packaging & NDC

Below are the non-prescription pack sizes of Axim Daytime - Night Time 48 Softgels, Axim Daytime - Night Time 72 Softgels (acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 4 to under 12 years should consult a doctor before use. The product is not recommended for children under 4 years of age. For adults and children over 12 years, the recommended dosage is 2 softgels with water every 4 hours during the Day Time or every 6 hours during the Night Time.

Caution is advised as excitability may occur, particularly in children during Night Time use. It is essential to keep this product out of reach of children.

Geriatric Use

Elderly patients should exercise caution when using this product, particularly those aged 65 and older, due to the increased likelihood of comorbidities and the potential for adverse effects. It is advisable for geriatric patients to consult a healthcare provider prior to use if they have a history of liver disease, glaucoma, chronic respiratory conditions (such as asthma, chronic bronchitis, or emphysema), or urinary difficulties related to an enlarged prostate gland.

Additionally, elderly patients taking anticoagulants, such as warfarin, or those on sedatives or tranquilizers should seek guidance from a healthcare professional or pharmacist before using this product.

When utilizing this medication, it is crucial for geriatric patients to adhere strictly to the recommended dosage, as exceeding the directed amount may lead to increased excitability, particularly in younger populations. Marked drowsiness is a potential side effect; therefore, elderly patients should avoid alcoholic beverages and be cautious when driving or operating machinery, as the combination of alcohol, sedatives, and tranquilizers can exacerbate drowsiness.

Elderly patients are advised to discontinue use and consult a healthcare provider if symptoms such as pain or cough worsen or persist beyond 7 days, if fever intensifies or lasts more than 3 days, or if new symptoms arise. The presence of redness or swelling, or a cough that recurs with a rash or headache lasting longer than usual, may indicate a serious condition requiring medical attention.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The safety of this drug during pregnancy has not been established, and potential risks to fetal outcomes are not fully understood. Therefore, it is essential for women of childbearing potential to seek medical advice to weigh the benefits and risks associated with the use of this medication during pregnancy and lactation.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no specific data available regarding 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 not been specifically addressed in the drug insert regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the absence of detailed 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. The presence of liver disease may increase the risk of adverse effects, particularly due to the acetaminophen content.

Severe liver damage may occur if patients exceed the recommended dosage of acetaminophen, which is limited to a maximum of 4,000 mg within a 24-hour period. Additionally, patients should avoid concurrent use of other medications containing acetaminophen, as this can further elevate the risk of liver toxicity.

Furthermore, consumption of three or more alcoholic drinks per day while using this product is contraindicated, as it may exacerbate the potential for liver damage. Careful monitoring of liver function is advised for patients with compromised liver function to prevent serious complications.

Overdosage

In the event of an accidental overdose, it is imperative to seek professional assistance or contact a poison control center without delay. Prompt action is crucial to ensure the safety and well-being of the patient.

Healthcare professionals should be aware that symptoms of overdose may vary depending on the specific substance involved. Monitoring the patient for any adverse effects is essential, as timely intervention can significantly impact the outcome.

Management of an overdose typically involves supportive care and symptomatic treatment. It is recommended that healthcare providers follow established protocols for overdose management, which may include the administration of activated charcoal if appropriate and the implementation of measures to stabilize the patient's condition.

In all cases of suspected overdose, thorough documentation and communication with the relevant medical teams are vital to facilitate effective treatment and follow-up care.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to use.

Acetaminophen has been associated with severe skin reactions, 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. Additionally, excitability may be observed, particularly in children, and marked drowsiness can occur. The concomitant use of alcohol, sedatives, or tranquilizers may exacerbate drowsiness.

No specific information regarding nonclinical toxicology or animal pharmacology and toxicology is available in the insert.

Postmarketing Experience

Postmarketing experience has identified that acetaminophen may be associated with severe skin reactions, which can manifest as skin reddening, blisters, or rash. In the event of a skin reaction, it is advised to discontinue use and seek medical assistance immediately.

Additionally, reports indicate that users should stop taking the medication and consult a healthcare professional if they experience symptoms such as increased nervousness, dizziness, or sleeplessness. Other concerning signs include worsening pain or cough lasting more than 7 days, fever that intensifies or persists beyond 3 days, the presence of redness or swelling, the emergence of new symptoms, or a recurrence of cough accompanied by rash or headache lasting for an extended period. These symptoms may indicate a serious underlying condition that requires medical evaluation.

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 drug 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 medication contains 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 encourage patients to consult a doctor before using this product if they have any of the following conditions: liver disease, heart disease, high blood pressure, diabetes, thyroid disease, or difficulty urinating due to an enlarged prostate gland. Patients should also be advised to seek medical advice if they have a cough that produces excessive phlegm or if they have a persistent or chronic cough associated with smoking, asthma, or emphysema. Lastly, patients taking the blood-thinning medication warfarin should be instructed to consult a doctor or pharmacist before using this product.

Storage and Handling

The product is supplied in a tamper-evident package. It is essential to inspect the carton and blister units prior to use; do not use the product if the carton is open or if the blister unit is broken.

For optimal storage, the product should be maintained at a temperature range of 20° to 25°C (68° to 77°F). Proper adherence to these storage conditions is 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 4 hours during the day and every 6 hours at night. For children aged 4 to under 12 years, consultation with a healthcare provider is recommended prior to use, while the product is not indicated for children under 4 years of age.

Clinicians should counsel patients to consult a health professional if they are pregnant or breastfeeding. It is important to keep the product out of reach of children, and in the event of an accidental overdose, patients should seek professional assistance or contact a poison control center immediately.

Drug Information (PDF)

This file contains official product information for Axim Daytime - Night Time 48 Softgels, Axim Daytime - Night Time 72 Softgels, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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