Nighttime Cold and Flu

Description

No description information is available for the specified drug.

Uses and Indications

This drug is indicated for the temporary relief of common cold and flu symptoms, including minor aches and pains, headache, sore throat, runny nose, sneezing, fever, and cough due to minor throat and bronchial irritation.

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

Dosage and Administration

Healthcare professionals should advise patients to adhere strictly to the recommended dosage guidelines. The maximum dosage should not exceed four doses within a 24-hour period.

For adults and children aged 12 years and older, the recommended dose is 30 mL administered every 6 hours as needed. It is imperative that the dosing cup provided with the medication is used for measurement; no other dosing devices should be utilized to ensure accurate dosing.

For children under 12 years of age, the use of this medication is not recommended.

When patients are using other Daytime or Nighttime products, they must carefully read each product label to confirm the correct dosing and avoid potential overdosing.

Contraindications

Use of this product is contraindicated in the following situations:

Patients currently taking a prescription monoamine oxidase inhibitor (MAOI) for depression, psychiatric or emotional conditions, or Parkinson's disease, or within 2 weeks of discontinuing an MAOI. The combination may lead to serious adverse effects. If there is uncertainty regarding the presence of an MAOI in a prescription drug, consultation with a healthcare professional is advised.

Concurrent use with any other drug containing acetaminophen, whether prescription or nonprescription, is also contraindicated due to the risk of acetaminophen overdose. If there is doubt about the acetaminophen content of a medication, a healthcare professional should be consulted.

Warnings and Precautions

This product contains acetaminophen, which poses a risk of severe liver damage if the following conditions are met: exceeding 4000 mg of acetaminophen within a 24-hour period, concomitant use with other medications containing acetaminophen, or consumption of three or more alcoholic beverages daily while using this product.

Acetaminophen may also lead to severe skin reactions, which can manifest as skin reddening, blisters, or rash. In the event of a skin reaction, it is imperative to discontinue use immediately and seek medical assistance.

Healthcare professionals should advise patients to consult a doctor promptly if they experience a sore throat that is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting.

Overdose of acetaminophen can result in liver damage. In cases of suspected overdose, immediate medical attention is crucial. Patients should be instructed to contact a Poison Control Center at 1-800-222-1222, even if no symptoms are apparent.

General precautions should be taken when using this product. Patients should be advised to consult a healthcare provider prior to use if they have any of the following conditions: liver disease, glaucoma, a cough associated with excessive phlegm, breathing problems or chronic cough related to smoking, asthma, chronic bronchitis, emphysema, or difficulty urinating due to an enlarged prostate gland. Additionally, patients should seek guidance from a doctor or pharmacist if they are taking sedatives, tranquilizers, or the anticoagulant warfarin.

While using this product, patients may experience excitability, particularly in children, and marked drowsiness. It is recommended to avoid alcoholic beverages, and caution should be exercised when driving or operating machinery, as alcohol, sedatives, and tranquilizers can exacerbate drowsiness.

Patients should be instructed to stop using the product and contact a healthcare provider if any of the following occur: pain or cough worsens or persists for more than seven days, new symptoms arise, fever worsens or lasts more than three days, redness or swelling is observed, or if a cough recurs or is accompanied by 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 who exceed 4000 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, which may also lead to liver damage, it is imperative for patients to seek immediate medical assistance or contact a Poison Control Center (1-800-222-1222), as prompt medical attention is critical for both adults and children, even in the absence of noticeable signs or symptoms.

Patients should be aware that acetaminophen may cause severe skin reactions, characterized by symptoms such as skin reddening, blisters, and rash. If any skin reaction occurs, patients are advised to discontinue use and seek medical help immediately.

In clinical settings, participants have reported excitability, particularly in children, as well as marked drowsiness. Patients are cautioned to avoid alcoholic beverages, as the combination of alcohol, sedatives, and tranquilizers may exacerbate drowsiness. Care should be taken when driving a motor vehicle or operating machinery due to the potential for increased sedation.

Patients should discontinue use and consult a healthcare provider if pain or cough worsens or persists beyond 7 days, if new symptoms arise, if fever intensifies or lasts more than 3 days, if redness or swelling is observed, or if a cough recurs alongside a rash or headache that lasts, as these may indicate a serious condition.

Before using this product, patients with liver disease, glaucoma, or chronic respiratory issues, such as a cough with excessive phlegm, asthma, chronic bronchitis, or emphysema, should consult a healthcare professional. Additionally, those experiencing urinary difficulties due to an enlarged prostate gland, or who are taking sedatives, tranquilizers, or the blood-thinning medication warfarin, should also seek medical advice prior to use.

Drug Interactions

There are currently no documented drug interactions associated with the use of 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 Nighttime Cold and Flu (acetaminophen, dextromethorphan hydrobromide, and 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 30 mL 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 children, even if no signs or symptoms are immediately apparent.

Geriatric Use

Elderly patients may use this product as it is indicated for adults and children aged 12 years and older. However, no specific geriatric use information is provided in the prescribing information.

While there are no dosage adjustments or special precautions explicitly outlined for geriatric patients, it is important for healthcare providers to exercise caution. It is advised that elderly patients consult a physician prior to use, particularly if they have underlying conditions such as liver disease or glaucoma, which may influence the safety and efficacy of the product.

Healthcare providers should remain vigilant in monitoring elderly patients for any potential adverse effects or complications associated with the use of this product, given the absence of specific geriatric considerations in the labeling.

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 considered, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to discuss their individual circumstances with a healthcare provider 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 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 exercise caution when using this product, which contains acetaminophen. Severe liver damage may occur if patients exceed 4000 mg of acetaminophen in a 24-hour period, use other medications containing acetaminophen concurrently, or consume three or more alcoholic drinks daily while using this product.

It is advised that patients with a history of liver disease consult a healthcare professional prior to use. The risk of liver damage increases significantly with the intake of doses above the recommended amount, and in the event of an overdose, immediate medical assistance should be sought. Patients are encouraged to contact a Poison Control Center (1-800-222-1222) without delay, as prompt medical attention is critical for both adults and children, even in the absence of noticeable signs or symptoms.

Overdosage

In the event of an overdose, it is crucial to recognize that exceeding the recommended dosage may lead to significant liver damage. Healthcare professionals should be aware that prompt medical intervention is essential for both adults and children, regardless of whether any symptoms are immediately apparent.

Recommended Actions In cases of suspected overdose, it is imperative to seek medical assistance without delay. Healthcare providers should advise patients or caregivers to contact a Poison Control Center at 1-800-222-1222 for immediate guidance and support.

Potential Symptoms While specific symptoms of overdose may vary, the risk of liver damage underscores the importance of vigilance. Symptoms may not be evident initially, which further emphasizes the necessity of seeking medical attention even in the absence of noticeable signs.

Management Procedures Upon receiving a report of an overdose, healthcare professionals should initiate appropriate management protocols. This may include monitoring liver function and providing supportive care as needed. Early intervention can significantly improve outcomes and mitigate the risk of severe complications.

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 to keep this product out of reach of children to prevent accidental ingestion. Patients should be informed not to use this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or within two weeks of stopping such medication. If patients are uncertain whether their prescription includes an MAOI, they should be encouraged to consult with a doctor or pharmacist.

It is important to instruct patients not to use this product in conjunction with any other medications containing acetaminophen, whether prescription or nonprescription. Patients should be reminded to verify the presence of acetaminophen in their other medications by consulting a healthcare professional if they are unsure.

Patients should be counseled to discontinue use and seek medical advice if their pain or cough worsens or persists for more than seven days. They should also be advised to stop using the product and consult a doctor if new symptoms arise, if fever worsens or lasts more than three days, or if there is any redness or swelling. Additionally, patients should be informed to seek medical attention if a cough returns or occurs alongside a rash or headache that persists, as these may indicate a serious condition.

When using this product, patients should be made aware that excitability may occur, particularly in children, and that marked drowsiness is a possible side effect. Patients should be cautioned to avoid alcoholic beverages while using this product, as well as to exercise caution when driving or operating machinery due to the potential for drowsiness. They should also be informed that the use of alcohol, sedatives, and tranquilizers may enhance drowsiness.

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

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 20-25°C (68-77°F). Refrigeration is not recommended, as it may compromise the integrity of the product. Proper handling and storage conditions must be adhered to in order to maintain the product's efficacy and safety.

Additional Clinical Information

The medication is administered orally, with a recommended dosage of 30 mL every 6 hours for adults and children aged 12 years and older. It is contraindicated for children under 12 years of age. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. Additionally, it is important to keep the medication out of reach of children. No further information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

Drug Information (PDF)

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

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