Nighttime Cold and Flu Relief

Description

AUROHEALTH Nighttime Relief Cold & Flu is a pharmaceutical formulation designed to alleviate symptoms associated with cold and flu. Each capsule contains a combination of active ingredients: Acetaminophen (325 mg), Dextromethorphan HBr (15 mg), and Doxylamine Succinate (6.25 mg). This product is presented in a capsule dosage form and is packaged in a size of 24 capsules. It is indicated for the relief of headache, fever, sore throat, minor aches and pains, sneezing, runny nose, and cough. The National Drug Code (NDC) for this product is 58602-769-78.

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, fever, as well as runny nose and sneezing.

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

Dosage and Administration

Patients should take the medication only as directed. The maximum dosage should not exceed 8 capsules within a 24-hour period.

For adults and children aged 12 years and older, the recommended dosage is 2 capsules taken with water every 6 hours as needed.

For children aged 4 to under 12 years, it is advised to consult a physician for appropriate dosing recommendations.

This medication is not intended for use in 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), which are utilized for the treatment of depression, psychiatric or emotional conditions, or Parkinson's disease, is contraindicated. This includes a prohibition on use for a period of 2 weeks following the discontinuation of an MAOI. If there is uncertainty about whether a prescription medication contains an MAOI, a healthcare professional should be consulted prior to use.

• Additionally, the product should not be used in excess of the directed dosage.

Warnings and Precautions

This product contains acetaminophen, which carries specific warnings and precautions that healthcare professionals must consider to ensure safe use.

Liver Warning Severe liver damage may occur if the maximum daily dosage of 8 capsules is exceeded within a 24-hour period. Additionally, the risk of liver damage increases when acetaminophen is taken in conjunction with other medications containing acetaminophen or when consumed with three or more alcoholic drinks daily while using this product. It is essential to monitor patients for signs of liver dysfunction, particularly in those who may be at higher risk due to concurrent medication use or alcohol consumption.

Allergy Alert Acetaminophen may lead to severe skin reactions, which can manifest as skin reddening, blisters, or rash. Should any of these symptoms occur, it is imperative to discontinue use immediately and seek medical assistance. Healthcare professionals should be vigilant in assessing patients for any signs of allergic reactions, particularly in those with a history of drug allergies.

Sore Throat Warning In cases of severe sore throat that persists for more than two days, or if it is accompanied or followed by fever, headache, rash, nausea, or vomiting, prompt consultation with a physician is advised. This may indicate a more serious underlying condition that requires further evaluation.

Emergency Medical Help In the event of an overdose, immediate medical attention is crucial. Healthcare providers should instruct patients or caregivers to contact a Poison Control Center at 1-800-222-1222 without delay, even if no symptoms are apparent. Quick intervention is vital for both adults and children.

Monitoring and Follow-Up Patients should be advised to discontinue use and consult a healthcare provider if any of the following occur: 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. These symptoms may indicate a serious condition that necessitates further medical evaluation. Regular follow-up and monitoring of symptoms are recommended to ensure patient safety and effective management.

Side Effects

Patients using this product should be aware of several important warnings and potential adverse reactions.

Severe liver damage may occur with the use of acetaminophen, particularly if patients exceed the maximum daily dosage of 8 capsules within a 24-hour period, use other medications containing acetaminophen concurrently, or consume 3 or more alcoholic drinks daily while taking this product.

Additionally, there is an allergy alert associated with acetaminophen, as it may lead to severe skin reactions. Symptoms of such reactions can include skin reddening, blisters, and rash. In the event of a skin reaction, patients are advised to discontinue use immediately and seek medical assistance.

Patients should also be cautious regarding sore throat symptoms. If a sore throat is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, it is recommended that they consult a healthcare professional promptly.

Furthermore, patients are advised to stop use and consult a doctor 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 occurs alongside a rash or headache that persists. These symptoms may indicate a serious condition requiring medical evaluation.

Drug Interactions

Co-administration 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) or within 2 weeks of discontinuing an MAOI. MAOIs are commonly prescribed for depression, psychiatric or emotional conditions, and Parkinson's disease. The combination may lead to serious adverse effects.

Patients should consult a healthcare professional prior to using this medication if they are concurrently taking sedatives or tranquilizers, as these substances may enhance drowsiness. Additionally, caution is advised for individuals taking the anticoagulant warfarin; consultation with a healthcare provider is recommended to assess the potential for increased bleeding risk.

It is important to note that the concomitant use of alcohol, sedatives, and tranquilizers with this medication may further increase drowsiness, necessitating careful monitoring of patients for excessive sedation and related effects.

Packaging & NDC

Below are the non-prescription pack sizes of Nighttime Cold and Flu Relief (acetaminophen, dextromethorphan hydrobromide and doxylamine succinate). 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 medication is contraindicated in children under 4 years of age. For adults and children aged 12 years and older, the recommended dosage is 2 capsules with water every 6 hours.

Caution is advised as excitability may occur, particularly in children. Additionally, marked drowsiness is a potential side effect. In the event of an overdose, it is critical to seek immediate medical attention for both adults and children, even if no signs or symptoms are apparent.

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. 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 not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

Hepatic Impairment

Patients with hepatic impairment should exercise caution when using this product, which contains acetaminophen. The maximum recommended dosage is 8 capsules in a 24-hour period; exceeding this limit may result in severe liver damage.

Additionally, patients should be aware that taking this product in conjunction with other medications containing acetaminophen can also lead to severe liver damage.

Furthermore, the risk of liver damage is heightened for patients who consume 3 or more alcoholic drinks daily while using this product. It is advisable for patients with compromised liver function to consult with a healthcare professional before using this product to ensure safe and appropriate use. Regular monitoring of liver function may be warranted in these patients to prevent potential adverse effects.

Overdosage

Severe liver damage may occur with an overdose of this product, which contains acetaminophen. Healthcare professionals should be aware that the maximum recommended dosage is 8 capsules within a 24-hour period. Exceeding this limit, particularly in conjunction with other medications containing acetaminophen or the consumption of 3 or more alcoholic beverages daily, significantly increases the risk of hepatotoxicity.

In the event of suspected overdosage, it is imperative to assess the patient's condition promptly. Symptoms of acetaminophen overdose may not be immediately apparent but can include nausea, vomiting, loss of appetite, confusion, and jaundice. Early recognition and intervention are crucial to mitigate potential liver damage.

Management of acetaminophen overdose typically involves the administration of N-acetylcysteine (NAC), which acts as an antidote and is most effective when given within 8 hours of ingestion. Healthcare providers should monitor liver function tests and consider supportive care as necessary. It is essential to provide patients with clear guidance on the importance of adhering to recommended dosages to prevent the risk of overdosage and its associated complications.

Nonclinical Toxicology

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

Excitability may occur, particularly in children, and marked drowsiness has been observed. The concomitant use of alcohol, sedatives, and tranquilizers may enhance drowsiness.

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

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 that the use of the product be discontinued immediately and medical assistance be sought.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical help or contact a Poison Control Center at 1-800-222-1222 in the event of an overdose, as prompt medical attention is crucial for both adults and children, even if no signs or symptoms are apparent.

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 about the presence of acetaminophen in their medications, they should consult a doctor or pharmacist for clarification.

It is important to instruct patients not to use this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have stopped taking an MAOI within the past two weeks. Patients should be encouraged to ask their healthcare provider or pharmacist if they are unsure whether their prescription medication contains an MAOI.

Patients should be advised to discontinue use and consult a doctor if their pain or cough worsens or persists for more than 7 days, if their fever worsens or lasts more than 3 days, if they notice any redness or swelling, or if new symptoms develop. Additionally, they should be informed to seek medical advice if a cough recurs or is accompanied by a rash or persistent headache, as these may indicate a serious condition.

While using this product, patients should be cautioned against exceeding the recommended dosage. They should be made aware that excitability may occur, particularly in children, and that marked drowsiness is a possible side effect. Patients should be advised to avoid alcoholic beverages, as well as to exercise caution when driving or operating machinery, given the potential for increased drowsiness when combined with alcohol, sedatives, or tranquilizers.

Patients with liver disease, glaucoma, a cough associated with excessive phlegm, breathing problems, chronic coughs related to smoking, asthma, chronic bronchitis, or emphysema should be encouraged to consult a doctor before using this product. Furthermore, those experiencing difficulty urinating due to an enlarged prostate gland, as well as patients taking sedatives, tranquilizers, or the blood-thinning medication warfarin, should also seek guidance from their healthcare provider or pharmacist prior to use.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers assigned for identification. It is essential to store the product at room temperature to maintain its integrity and efficacy. Proper handling should be observed to ensure the product remains within the recommended storage conditions.

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. It is essential to keep the medication out of reach of children. In the event of an overdose, patients should seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222, as prompt medical attention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Drug Information (PDF)

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

View product document (PDF)