Axiv Daytime

Description

AXIV - DayTime COLD&FLU is a multi-symptom relief formulation designed to alleviate various cold and flu symptoms. It contains acetaminophen as a pain reliever and fever reducer, along with dextromethorphan HBr as a cough suppressant and a nasal decongestant. The product is presented in liquid-filled softgel capsules, available in two packaging sizes: 24 softgels (NDC 82706-015-01) and 100 softgels (NDC 82706-015-03). This formulation is specifically designed to provide non-drowsy relief. It is important to note that this product is not manufactured or distributed by The Procter & Gamble Company, which owns the registered trademarks Vicks® DayQuil® and LiquiCaps®.

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, 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 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 4 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 medication is not recommended for children under 4 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, as the combination may lead to serious adverse effects. If there is uncertainty about the presence of an MAOI in a prescription, a healthcare professional should be consulted.

• History of allergic reaction to this product or any of its ingredients, as this may result in 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 8 Softgels within a 24-hour period, using other medications that also contain acetaminophen, or consuming three 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 two days, or is accompanied by fever, headache, rash, nausea, or vomiting, prompt consultation with a healthcare provider is advised.

Healthcare professionals should advise patients to consult a doctor prior to use if they have a history of liver disease, a cough associated with excessive phlegm, or a persistent or chronic cough related to smoking, asthma, or emphysema. It is crucial that patients do not exceed the recommended dosage while using this product.

In cases of accidental overdose, immediate professional assistance should be sought, or the Poison Control Center should be contacted without delay.

Patients should be instructed 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 lasts longer 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 persists. These symptoms may indicate a serious underlying condition that requires medical 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 the product in conjunction with other medications containing acetaminophen, or consume three or more alcoholic drinks daily while using this product.

Patients should be aware that acetaminophen may cause 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 and seek medical assistance immediately.

If a patient experiences a sore throat that is severe, lasts longer than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, they should consult a doctor promptly.

This product should not be used in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription. Patients uncertain about the presence of acetaminophen in their medications should consult a healthcare professional. Additionally, this product is contraindicated for individuals currently taking a prescription monoamine oxidase inhibitor (MAOI) or those who have taken an MAOI within the past two weeks. Patients with a known allergy to this product or any of its ingredients should also refrain from use.

Before using this product, patients should consult a doctor if they have liver disease, a cough that produces excessive phlegm, or a persistent or chronic cough associated with smoking, asthma, or emphysema.

While using this product, patients must adhere to the recommended dosage and should discontinue use and seek medical advice 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 develop, or if a cough recurs with a rash or headache that lasts. These symptoms may indicate a serious condition.

In the event of an accidental overdose, patients should seek professional assistance or contact a Poison Control Center immediately.

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, which can lead to severe liver damage.

Additionally, this medication should not be administered to patients currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications used for the treatment of depression, psychiatric disorders, or Parkinson's disease. It is also advised that this medication not be used for at least two weeks following the discontinuation of an MAOI to avoid potential serious interactions.

Monitoring for adverse effects is recommended in patients who may have recently stopped MAOI therapy, and alternative treatment options should be considered in these cases.

Packaging & NDC

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

Pediatric Use

Pediatric patients aged 4 to under 12 years should consult a healthcare professional prior to use. The product is contraindicated in children under 4 years of age. For adolescents and adults aged 12 years and older, the recommended dosage is 2 softgels taken with water every 4 hours, with a maximum of 8 softgels in a 24-hour period.

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. 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 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 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.

Patients with compromised liver function are also advised to limit alcohol consumption to fewer than 3 alcoholic drinks per day while using this product, as alcohol can exacerbate the potential for liver damage.

It is recommended that patients with a history of liver disease consult a healthcare professional prior to using this product to ensure safe and appropriate use. Regular monitoring of liver function may be warranted in these patients to detect any potential adverse effects early.

Overdosage

In the event of an accidental overdose, it is imperative to seek professional assistance without delay. Healthcare professionals should be contacted, or a Poison Control Center should be reached immediately to ensure appropriate management of the situation.

Symptoms of overdose may vary depending on the specific substance involved; therefore, a thorough assessment by a medical professional is essential. Prompt recognition of symptoms can facilitate timely intervention and improve patient outcomes.

Management of an overdose typically involves supportive care and symptomatic treatment. Healthcare providers should monitor the patient closely and provide necessary interventions based on the clinical presentation. It is crucial to follow established protocols for overdose management, which may include decontamination, administration of antidotes if applicable, and supportive measures to stabilize the patient.

In summary, immediate action and professional guidance are critical in the event of an overdose to mitigate potential risks and ensure the safety of the patient.

Nonclinical Toxicology

There is currently no available information regarding teratogenic effects. Additionally, no data has been provided concerning non-teratogenic effects. The nonclinical toxicology section does not contain any relevant information at this time. Furthermore, there is no information available related to animal pharmacology and toxicology.

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 informed 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 with a doctor or pharmacist.

It is crucial 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 last two weeks. Patients should be advised to check with their healthcare provider or pharmacist 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 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. Additionally, patients should be advised to consult a doctor if new symptoms arise or if their cough returns or occurs alongside a rash or headache that lasts, as these may indicate a serious condition.

While using this product, patients must not exceed the recommended dose. It is also important for healthcare providers to remind patients to consult a doctor before using this product if they have liver disease, a cough that produces excessive phlegm, or a persistent or chronic cough associated with smoking, asthma, or emphysema.

Storage and Handling

The product is supplied in a tamper-evident packaging format. It is essential to inspect the carton and blister units prior to use; do not utilize the product if the carton is open or if the blister unit is broken. Additionally, the product should not be used if the carton or pouch is open.

For optimal storage, the product must 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

The medication is administered orally, with the recommended dosage for adults and children aged 12 years and older being 2 softgels taken with water every 4 hours. For children aged 4 to under 12 years, it is advised to consult a doctor before use, while the medication is not recommended for children under 4 years of age.

Clinicians should counsel patients to seek advice from a health professional if they are pregnant or breastfeeding prior to using the medication. No additional information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

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

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