Night Time Cold and Flu Relief

Description

Acetaminophen is a non-opioid analgesic and antipyretic agent, utilized for the relief of pain and reduction of fever. Dextromethorphan hydrobromide serves as a cough suppressant, providing symptomatic relief from cough. Diphenhydramine succinate functions as an antihistamine, aiding in the management of allergic symptoms. The formulation is presented in softgels, specifically liquid-filled capsules, designed for oral administration.

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. For adults and children aged 12 years and older, the prescribed dosage is 2 softgels taken with water every 6 hours, not to exceed 4 doses within a 24-hour period. It is imperative that the softgels are swallowed whole; they must not be crushed, chewed, or dissolved to ensure proper release and absorption of the medication.

For children under 12 years of age, the use of this medication is not recommended. Additionally, when utilizing other Daytime or Nighttime products, healthcare professionals should advise patients to carefully read each product label to confirm appropriate dosing and avoid potential overdose.

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, as this may lead to serious drug interactions. If there is uncertainty about the presence of an MAOI in a prescription medication, a healthcare professional should be consulted.

Additionally, it is important to adhere to the recommended dosage and to avoid the consumption of alcoholic beverages while using this product.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen. Healthcare professionals should advise patients to avoid exceeding 4,000 mg of acetaminophen within a 24-hour period. Caution is also warranted when this product is used in conjunction with other medications containing acetaminophen or when patients consume three or more alcoholic drinks daily while using this product.

Acetaminophen has been associated with severe skin reactions. Symptoms indicative of such reactions may include skin reddening, blisters, and rash. Should any of these symptoms manifest, patients must discontinue use immediately and seek medical assistance.

In cases of severe sore throat, particularly if it persists for more than two days or is accompanied by fever, headache, rash, nausea, or vomiting, patients should be advised to consult a physician without delay.

In the event of an overdose, it is imperative to seek medical help or contact a Poison Control Center immediately. Prompt medical attention is crucial for both adults and children, even if no signs or symptoms are initially apparent.

Patients should be instructed to stop use and consult a healthcare professional 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 persists. These symptoms may indicate a serious underlying condition that requires further evaluation.

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 4,000 mg in a 24-hour period, combine it with other medications containing acetaminophen, or consume three or more alcoholic drinks daily while using this product. In cases of overdose, immediate medical attention is critical for both adults and children, even if no signs or symptoms are initially present, as this can lead to significant liver damage.

Patients should also be alert for severe skin reactions associated with acetaminophen, which may manifest as skin reddening, blisters, or rash. If any of these symptoms occur, patients are advised to discontinue use and seek medical assistance promptly.

In clinical observations, excitability has been noted, particularly in children, and marked drowsiness may occur in some patients. The use of alcohol, sedatives, or tranquilizers can exacerbate drowsiness, necessitating caution when driving or operating machinery.

Patients are advised to stop using the product and consult a healthcare provider if pain or cough worsens or persists beyond 7 days, if fever worsens or lasts more than 3 days, if redness or swelling is observed, if new symptoms develop, or if a cough recurs with a rash or headache that lasts. These symptoms may indicate a serious underlying condition.

Overall, careful monitoring of symptoms and adherence to recommended dosages are essential to minimize the risk of adverse reactions associated with this product.

Drug Interactions

Concurrent use of this medication with other products containing acetaminophen, whether prescription or nonprescription, is contraindicated due to the risk of acetaminophen overdose.

The use of this medication is also contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) for conditions such as depression, psychiatric disorders, or Parkinson's disease, as well as for a period of two weeks following the discontinuation of an MAOI.

Patients taking the anticoagulant warfarin should consult a healthcare professional prior to using this medication, as there may be an increased risk of bleeding.

Additionally, caution is advised for individuals using sedatives or tranquilizers. The concomitant use of alcohol, sedatives, and tranquilizers may enhance drowsiness, necessitating careful monitoring of sedation levels and potential impairment in activities requiring alertness.

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

Pediatric patients under 12 years of age should not use this product. For adolescents aged 12 years and older, the recommended dosage is 2 softgels taken with water every 6 hours.

Caution is advised as excitability may occur, particularly in children. In the event of an overdose, prompt medical attention is essential for both adults and pediatric patients, even if no signs or symptoms are immediately apparent.

Geriatric Use

Elderly patients may not require specific dosage adjustments or face unique safety concerns when using this product. However, it is important to note that the product may cause marked drowsiness, which could be particularly concerning for this population.

Due to the potential for drowsiness, elderly patients should exercise caution when driving a motor vehicle or operating machinery. Additionally, it is advisable for elderly patients to consult a healthcare provider prior to use if they have a history of liver disease, glaucoma, difficulty urinating due to an enlarged prostate gland, or any breathing problems or chronic cough. Monitoring and careful consideration of these factors are recommended to ensure the safe use of the product in geriatric patients.

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 medication 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 absence of 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 be aware that this product contains acetaminophen, which carries a risk of severe liver damage. It is crucial for these patients to adhere to the following guidelines to minimize the risk of hepatotoxicity.

Patients should not exceed 4,000 mg of acetaminophen in a 24-hour period. Additionally, they must avoid the concurrent use of other medications containing acetaminophen, as this can further increase the risk of liver damage. Consumption of three or more alcoholic drinks per day while using this product is also contraindicated, as it may exacerbate liver function impairment.

Before using this product, patients with known liver disease should consult a healthcare professional. It is essential for these patients to be monitored closely for any signs of liver dysfunction, particularly if they are taking the maximum recommended dose or have other risk factors for liver injury.

In the event of an overdose, which can lead to significant liver damage, immediate medical attention is necessary. Patients should seek help or contact a Poison Control Center without delay, as prompt intervention is critical for both adults and children, even in the absence of noticeable symptoms.

Overdosage

In the event of an overdose, it is crucial to recognize the potential for serious health consequences, particularly liver damage, which may occur when the recommended dosage is exceeded. Healthcare professionals should advise patients and caregivers to seek immediate medical assistance or contact a Poison Control Center without delay if an overdose is suspected.

Recommended Actions

Prompt medical attention is essential for both adults and children, even in the absence of noticeable signs or symptoms. The lack of immediate symptoms does not preclude the possibility of significant harm, and therefore, vigilance is necessary.

Potential Symptoms

While specific symptoms of overdose may vary, the risk of liver damage is a primary concern. Healthcare providers should monitor for any signs of hepatic impairment and be prepared to initiate appropriate interventions.

Management Procedures

Upon identification of an overdose, healthcare professionals should follow established protocols for managing such cases. This may include supportive care, monitoring of liver function, and other interventions as deemed necessary based on the clinical presentation.

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 limits the assessment of potential risks associated with the use of the compound in these contexts.

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions associated with acetaminophen use: severe skin reactions, which include skin reddening, blisters, and rash. These events have been reported voluntarily or through surveillance programs.

Patient Counseling

Healthcare providers should advise patients not to exceed the recommended dosage, as taking more than the prescribed amount can lead to liver damage. In the event of an overdose, patients should seek medical help or contact a Poison Control Center immediately, as prompt medical attention is crucial 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 avoid consuming alcoholic beverages while using this medication. Marked drowsiness is a potential side effect, and the use of alcohol, sedatives, or tranquilizers may exacerbate this drowsiness. Therefore, patients should exercise caution when driving or operating machinery.

Patients should be instructed to discontinue use and consult a doctor if their pain or cough worsens or persists for more than 7 days, if fever worsens or lasts longer than 3 days, or if they notice any redness or swelling. They should also seek medical advice if new symptoms arise or if a cough recurs alongside a rash or headache that lasts, as these may indicate a serious condition.

It is important for patients to consult a doctor before using this medication if they have liver disease, glaucoma, difficulty urinating due to an enlarged prostate gland, or any breathing problems or chronic coughs, such as those associated with smoking, asthma, chronic bronchitis, or emphysema. Additionally, patients should seek guidance from a doctor or pharmacist if they are taking the blood-thinning medication warfarin or if they are using sedatives or tranquilizers.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at a temperature range of 15-30ºC (59-86ºF) to maintain its efficacy. Care should be taken to avoid exposure to excessive heat, as this may compromise the integrity of the product. Proper storage conditions are crucial for ensuring the quality and safety of the product throughout its shelf life.

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.

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