Nitetime Severe Cold and Flu Relief Softgels

Description

No description information is available for the specified 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, sinus congestion and pressure, cough due to minor throat and bronchial irritation, cough to facilitate sleep, minor aches and pains, headache, fever, sore throat, runny nose, and sneezing.

Additionally, this drug reduces swelling of the nasal passages, temporarily restores freer breathing through the nose, and promotes nasal and/or sinus drainage.

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

Dosage and Administration

The medication should be taken only as directed. For adults and children aged 12 years and older, the recommended dosage is 2 softgels taken with water every 4 hours, not to exceed 8 softgels within a 24-hour period.

For children aged 4 to under 12 years, it is advised to consult a physician for appropriate dosing. The use of this medication is not recommended for children under 4 years of age.

Contraindications

There are no specific contraindications listed for this product. However, it is essential to keep the product out of reach of children to prevent accidental ingestion. In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center for guidance.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen. Healthcare professionals should advise patients to adhere strictly to the maximum daily dosage of 8 softgels within a 24-hour period. Caution is warranted if patients are concurrently using other medications containing acetaminophen, consuming three or more alcoholic drinks daily, or have a history of liver disease.

Acetaminophen may also provoke severe skin reactions, which can manifest as skin reddening, blisters, or rash. Should any of these symptoms arise, 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 instructed to consult a physician without delay.

Patients should be advised against using this product in conjunction with any other medications containing acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in other medications, patients should consult a healthcare professional. Additionally, this product should not be used by individuals currently taking a prescription monoamine oxidase inhibitor (MAOI) or within two weeks of discontinuing such medication.

Healthcare professionals should recommend that patients seek medical advice prior to using this product if they have any of the following conditions: liver disease, heart disease, high blood pressure, thyroid disease, diabetes, glaucoma, difficulty urinating due to an enlarged prostate, or a cough associated with excessive phlegm. Patients with a history of breathing problems or chronic cough, particularly those related to smoking, asthma, chronic bronchitis, or emphysema, should also consult a physician.

Patients taking sedatives, tranquilizers, or the blood-thinning medication warfarin should be advised to consult a doctor or pharmacist before using this product.

While using this product, patients must not exceed the recommended dosage. It is important to note that excitability may occur, particularly in children, and marked drowsiness may be experienced. Patients should be cautioned to avoid alcoholic beverages, as well as sedatives and tranquilizers, which may exacerbate drowsiness. Care should be taken when driving or operating machinery.

In the event of an overdose, immediate medical attention should be sought, or the Poison Control Center should be contacted.

Patients should discontinue use and contact a healthcare provider if they experience nervousness, dizziness, or sleeplessness; if pain, nasal congestion, 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 requiring medical evaluation.

Side Effects

Severe liver damage may occur in patients taking this product containing acetaminophen if they exceed the maximum daily amount of 8 softgels within 24 hours, use other medications containing acetaminophen concurrently, or consume 3 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 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, patients are advised to consult a healthcare professional promptly.

While using this product, patients may experience excitability, particularly in children, as well as marked drowsiness. It is recommended to avoid alcoholic beverages, as well as to exercise caution when driving or operating machinery, due to the potential for increased drowsiness when combined with alcohol, sedatives, or tranquilizers.

Patients should discontinue use and consult a doctor if they experience nervousness, dizziness, or sleeplessness; if pain, nasal congestion, or cough worsens or persists beyond 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 or is accompanied by a rash or headache lasting longer than expected, as these may indicate a serious condition.

In the event of an overdose, it is crucial for patients to seek medical help or contact a Poison Control Center immediately.

Drug Interactions

There are currently no documented drug interactions associated with 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 Nitetime Severe Cold and Flu Relief 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 healthcare professional before use. The product is not recommended for children under 4 years of age. For dosing, adults and children aged 12 years and older may take 2 softgels with water every 4 hours, with a maximum of 8 softgels in a 24-hour period. Caution is advised as excitability may occur, particularly in children.

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 safe use during pregnancy and lactation.

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 text. Therefore, healthcare professionals should exercise caution and consider individual patient factors when prescribing to this population. Regular assessment of renal function may be warranted to ensure safe and effective use of the medication in patients with reduced kidney function.

Hepatic Impairment

Patients with hepatic impairment should exercise caution when using this product, as it contains acetaminophen, which is associated with the risk of severe liver damage. It is critical that patients do not exceed the maximum daily dosage of 8 softgels within a 24-hour period. Additionally, patients should avoid concurrent use of other medications containing acetaminophen and limit alcohol consumption to fewer than 3 drinks per day while using this product.

Before initiating treatment, patients with known liver disease are advised to consult a healthcare professional. Monitoring of liver function may be warranted in these patients to ensure safety and efficacy during the course of therapy.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Prompt intervention is crucial to mitigate potential adverse effects associated with the overdose.

Healthcare professionals should be vigilant in monitoring for symptoms that may arise from an overdose. While specific symptoms are not detailed in the provided information, it is essential to be aware that they can vary based on the substance involved and the individual patient’s response.

Management of an overdose typically involves supportive care and symptomatic treatment. Healthcare providers are advised to follow established protocols for overdose management, which may include decontamination, monitoring vital signs, and providing appropriate interventions based on the clinical presentation.

In summary, timely medical intervention and adherence to established management guidelines are critical in addressing overdose situations effectively.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data in these areas limits the understanding of the compound's potential effects in nonclinical settings.

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 the medication out of reach of children to prevent accidental ingestion. It is important for patients to understand the potential risks associated with overdose. In the event of an overdose, patients should be instructed to seek medical help immediately or contact a Poison Control Center for assistance. This information is crucial for ensuring patient safety and promoting responsible use of the medication.

Storage and Handling

The product is supplied in packaging that ensures its integrity and stability. It should be stored at a controlled room temperature, maintained between 20-25°C (68-77°F). It is essential to protect the product from light, heat, and moisture to preserve its efficacy and safety. Proper handling and storage conditions are critical to maintaining the quality of the product throughout its shelf life.

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 experience.

Drug Information (PDF)

This file contains official product information for Nitetime Severe Cold and Flu Relief Softgels, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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