Night Time Cold and Flu Relief

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 sore throat, headache, minor aches and pains, fever, runny nose, sneezing, and cough due to minor throat and bronchial irritation.

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

Dosage and Administration

Patients should adhere strictly to the recommended dosage guidelines to avoid potential overdose. The maximum allowable dosage is four doses within a 24-hour period.

For adults and children aged 12 years and older, the recommended dosage is two softgels taken with water every six hours as needed. It is imperative that the softgels are swallowed whole; they must not be crushed, chewed, or dissolved prior to ingestion.

This medication is not indicated for use in children under 12 years of age.

Contraindications

Use of this product is contraindicated in the following situations:

Patients should not use this product in conjunction with any other medication containing acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in a medication, consultation with a healthcare professional is advised.

The product is also contraindicated in individuals currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such treatment. MAOIs are typically prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. If there is any doubt about the presence of an MAOI in a prescription, a healthcare professional should be consulted prior to use.

Additionally, patients should not exceed the recommended dosage and should avoid the consumption of alcoholic beverages while using this product.

Warnings and Precautions

This product contains acetaminophen, which carries significant risks that healthcare professionals must communicate to patients.

Liver Warning Severe liver damage may occur if the patient exceeds 4,000 mg of acetaminophen within a 24-hour period, uses other medications containing acetaminophen concurrently, or consumes three or more alcoholic drinks daily while using this product. It is imperative to monitor patients for signs of liver dysfunction, particularly in those with pre-existing liver conditions.

Allergy Alert Acetaminophen may induce severe skin reactions, which can manifest as skin reddening, blisters, or rash. Should any of these symptoms arise, patients must be advised 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 is accompanied by fever, headache, rash, nausea, or vomiting, patients should be instructed to consult a physician without delay.

General Precautions Healthcare professionals should advise patients to consult a doctor prior to use if they have any of the following conditions: liver disease, glaucoma, difficulty urinating due to an enlarged prostate gland, or respiratory issues such as chronic cough, asthma, chronic bronchitis, or emphysema. Additionally, patients taking blood thinners like warfarin or those on sedatives or tranquilizers should seek guidance from a healthcare provider or pharmacist before using this product.

Emergency Medical Help In the event of an overdose, immediate medical attention is crucial. Patients should be instructed to contact a Poison Control Center (1-800-222-1222) or seek emergency medical help right away, regardless of the presence of symptoms.

Monitoring and Follow-Up Patients should be advised to discontinue use and contact their healthcare provider if any of the following occur: pain or cough worsens or persists beyond seven days; fever worsens or lasts more than three days; redness or swelling is observed; new symptoms develop; or if a cough recurs alongside a rash or headache that lasts. These symptoms may indicate a serious underlying condition that requires further evaluation.

Side Effects

Patients using this product should be aware of several potential adverse reactions, which can vary in seriousness and frequency.

Severe liver damage is a significant concern associated with the use of this product, particularly due to its acetaminophen content. Patients are at increased risk if they 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. In cases of overdose, immediate medical attention is crucial, and patients are advised to contact a Poison Control Center (1-800-222-1222) without delay, as prompt intervention is essential for both adults and children.

Allergic reactions may also occur, with severe skin reactions being a notable risk. Symptoms of such reactions can include skin reddening, blisters, and rash. Should any of these symptoms manifest, patients must discontinue use and seek medical assistance immediately.

Patients may experience excitability, particularly in children, as well as marked drowsiness. The use of alcohol, sedatives, or tranquilizers may exacerbate drowsiness, necessitating caution when driving or operating machinery.

Additional warnings include the need to consult a healthcare provider if a sore throat is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting. Patients should also stop using the product and seek medical advice 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, or if new symptoms arise. The recurrence of cough, especially when accompanied by rash or headache, may indicate a serious condition requiring medical evaluation.

Overall, careful adherence to dosing recommendations and monitoring for adverse reactions is essential for the safe use of this product.

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 Night Time Cold and Flu Relief (acetaminophen, dextromethorphan hydrobromide, doxylamine succinate). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Children under 12 years should not use this medication. For adults and children aged 12 years and older, the recommended dosage is 2 softgels taken with water every 6 hours.

Healthcare professionals should be aware that excitability may occur, particularly in pediatric patients. In the event of an overdose, prompt medical attention is essential for both adults and children, even if no signs or symptoms are immediately apparent.

Geriatric Use

There is no specific information available 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. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy, 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. 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 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 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 be closely monitored when using this product, which contains acetaminophen. It is important to note that severe liver damage may occur if patients exceed 4,000 mg of acetaminophen in a 24-hour period, take this product in conjunction with other medications containing acetaminophen, or consume three 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. Due to the potential for overdose and subsequent liver damage, it is critical that patients adhere to the recommended dosage. In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center (1-800-222-1222) should be contacted without delay. Prompt medical attention is essential for both adults and children, even if no signs or symptoms of overdose are apparent.

Overdosage

In cases of overdosage, it is crucial to recognize the potential for serious health consequences, particularly concerning liver damage. Healthcare professionals should be aware that exceeding the recommended dosage can lead to significant adverse effects.

Recommended Actions In the event of an overdose, immediate medical assistance is essential. Healthcare providers should advise patients or caregivers to contact a Poison Control Center at 1-800-222-1222 without delay. Prompt medical intervention is vital for both adults and children, even in the absence of noticeable symptoms.

Potential Symptoms While specific symptoms of overdose may not always be evident, the risk of liver damage underscores the importance of vigilance. Healthcare professionals should monitor for any signs of hepatic impairment and be prepared to initiate appropriate management protocols.

Management Procedures Upon confirmation of an overdose, healthcare providers should follow established guidelines for the assessment and treatment of liver toxicity. This may include supportive care and monitoring of liver function tests, as well as considering the need for further interventions based on the severity of the overdose and the patient's clinical status.

Nonclinical Toxicology

If pregnant or breast-feeding, it is advised to consult a health professional before use. No specific non-teratogenic effects have been identified in the available data. Additionally, there are no detailed findings regarding nonclinical toxicology or animal pharmacology and toxicology provided in the current information.

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions: severe skin reactions, which may manifest 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 not to exceed the recommended dosage of the medication, as taking more than the prescribed amount can lead to liver damage. In the event of an overdose, it is crucial for patients to seek medical assistance immediately or contact a Poison Control Center at 1-800-222-1222, as prompt medical attention is essential for both adults and children, even if no signs or symptoms are apparent.

Patients should be informed that excitability may occur, particularly in children, and they should be cautious about the potential for marked drowsiness. It is important to counsel patients to avoid consuming alcoholic beverages while taking this medication, as alcohol, along with sedatives and tranquilizers, may enhance drowsiness. Additionally, patients should be advised to exercise caution when driving a motor vehicle or operating machinery due to the risk of impaired alertness.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It should be stored at a temperature range of 15º to 30ºC (59º to 86ºF). Care should be taken to avoid exposure to excessive heat to maintain product integrity. Proper storage conditions are essential to ensure the efficacy and safety of the product.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)