Night Time Cold and Flu

Description

Acetaminophen, dextromethorphan, and doxylamine succinate are the active ingredients in this formulation. Acetaminophen serves as a pain reliever and fever reducer, while dextromethorphan functions as a cough suppressant, and doxylamine succinate acts as an antihistamine. The product is alcohol-free and is presented in the form of softgels, specifically liquid-filled capsules.

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 to avoid the risk of 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. It is imperative that the softgels are swallowed whole; they must not be crushed, chewed, or dissolved prior to ingestion.

This product is not intended for use in children under 12 years of age.

When utilizing other Daytime or Nighttime products, healthcare professionals should advise patients to carefully read each label to ensure accurate dosing and avoid exceeding the recommended limits.

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 uncertain about the presence of acetaminophen in other medications, consult a healthcare professional.

• 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 regarding the presence of an MAOI in a prescription medication, seek advice from a healthcare professional.

Additionally, it is advised not to exceed the recommended dosage and to avoid the consumption of alcoholic beverages while using this product.

Warnings and Precautions

This product contains acetaminophen, which carries a significant risk of severe liver damage if not used according to the specified guidelines. Healthcare professionals should advise patients to avoid exceeding 4,000 mg of acetaminophen within a 24-hour period. Additionally, patients should be cautioned against the concurrent use of other medications containing acetaminophen and the consumption of three or more alcoholic drinks daily while using this product.

Acetaminophen may also induce severe skin reactions. Symptoms indicative of such reactions include skin reddening, blisters, and rash. In the event of any skin reaction, patients must discontinue use immediately and seek medical assistance.

Healthcare providers should be vigilant regarding patients presenting with a sore throat. If the sore throat is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, prompt consultation with a physician is warranted.

Patients should be instructed to stop using the product and consult a healthcare professional if any of the following occur: pain or cough worsens or lasts longer than seven days; fever worsens or persists beyond three days; redness or swelling develops; new symptoms arise; or if a cough recurs or is accompanied by a rash or headache that lasts. These symptoms may indicate a serious underlying condition requiring further evaluation.

In cases of suspected overdose, immediate medical attention is essential. Patients should be advised to contact a Poison Control Center (1-800-222-1222) without delay, as rapid intervention is critical for both adults and children, even in the absence of noticeable signs or symptoms.

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, 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 critical; patients are advised to contact a Poison Control Center (1-800-222-1222) without delay, even if no symptoms are present.

Patients may also experience severe skin reactions, which can manifest as skin reddening, blisters, or rash. If any of these symptoms occur, it is imperative to discontinue use and seek medical assistance promptly. Additionally, if a sore throat is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, patients should consult a healthcare provider immediately.

Common adverse reactions may include excitability, particularly in children, and marked drowsiness. The use of alcohol, sedatives, or tranquilizers may exacerbate drowsiness, and patients are cautioned to exercise caution when driving or operating machinery.

Patients should also stop using the product and consult a doctor if pain or cough worsens or lasts more than seven days, if fever worsens or lasts more than three days, if redness or swelling is present, if new symptoms develop, or if a cough recurs with a rash or headache lasting longer than expected. These symptoms could indicate a serious underlying condition.

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 and potential hepatotoxicity.

The use of this medication is also contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) for depression, psychiatric or emotional conditions, or Parkinson's disease, and for a period of 2 weeks following the discontinuation of the MAOI. This interaction may lead to serious adverse effects, including hypertensive crises.

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

Additionally, caution is advised for individuals using sedatives or tranquilizers. The concomitant use of alcohol, sedatives, and tranquilizers may enhance drowsiness, which could impair the ability to perform tasks requiring alertness. Monitoring for increased sedation and potential respiratory depression is recommended in these cases.

Packaging & NDC

Below are the non-prescription pack sizes of Night Time Cold and Flu (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 medication. For adolescents 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 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

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.

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 maternal health. 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 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. 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 daily while using this product is also contraindicated, as it may exacerbate liver injury.

Before using this product, patients with liver disease should consult a healthcare professional. It is essential to assess liver function and determine the appropriateness of this medication in the context of their overall health status.

In the event of an overdose, which can lead to significant liver damage, patients must seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222. Prompt medical attention is critical for both adults and children, even if no signs or symptoms of overdose are apparent.

Overdosage

Taking more than the recommended dose of this medication can lead to significant liver damage. It is crucial for healthcare professionals to be aware of the potential severity of an overdose and the importance of prompt intervention.

In the event of an overdose, immediate medical assistance should be sought. Healthcare providers are advised to contact a Poison Control Center at 1-800-222-1222 for guidance on management. Quick medical attention is essential for both adults and children, even in cases where no signs or symptoms are immediately apparent. Early intervention can be critical in mitigating the risks associated with overdose and ensuring patient safety.

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 assistance immediately or contact a Poison Control Center at 1-800-222-1222, as prompt medical attention is crucial for both adults and children, even if no signs or symptoms are present.

Patients should be informed that excitability may occur, particularly in children, and that marked drowsiness is a possible side effect. It is important to counsel patients to avoid alcoholic beverages, as alcohol, sedatives, and tranquilizers can enhance drowsiness. Patients should exercise caution when driving or operating machinery due to the potential for increased drowsiness.

Healthcare providers should encourage patients to consult a doctor before using the medication if they have any of the following conditions: liver disease, glaucoma, difficulty urinating due to an enlarged prostate gland, breathing problems or chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema, or a cough that produces excessive phlegm (mucus). Additionally, patients taking the blood-thinning medication warfarin, or those using sedatives or tranquilizers, should also seek advice from a doctor or pharmacist prior to use.

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, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)