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, 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

Adults and children aged 12 years and over are advised to take 30 mL every 6 hours, with a maximum of 4 doses within a 24-hour period. It is imperative that the medication is measured exclusively with the dosing cup provided; the use of any other dosing device is not recommended.

For children under 12 years of age, the use of this medication is contraindicated. When utilizing other Day Time or Night Time products, healthcare professionals should instruct patients to carefully read each label to ensure accurate 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, as well as for 2 weeks following the discontinuation of 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.

Additionally, this product should not be used concurrently with any other medication containing acetaminophen, whether prescription or non-prescription, due to the risk of acetaminophen overdose. If there is any doubt about the acetaminophen content of a medication, a healthcare professional should be consulted.

Warnings and Precautions

This product contains acetaminophen, which carries a significant risk of severe liver damage under certain conditions. Healthcare professionals should advise patients to avoid exceeding 4,000 mg of acetaminophen within a 24-hour period. Additionally, patients should not use this product concurrently with other medications containing acetaminophen or consume three or more alcoholic beverages daily while using this product.

Acetaminophen may also induce severe skin reactions. Symptoms indicative of such reactions 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 instructed to consult a physician without delay.

Healthcare professionals must emphasize the importance of adhering to the recommended dosage, as exceeding this can lead to overdose and potential liver damage. In the event of an overdose, immediate medical attention is crucial. Patients should be advised to contact a Poison Control Center (1-800-222-1222) promptly, even if no symptoms are apparent.

Patients should also be instructed to stop using the product and consult a 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 develops; new symptoms arise; 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 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, which may result from taking more than the recommended dose, immediate medical attention is critical. Patients are advised to contact a Poison Control Center (1-800-222-1222) without delay, even if no signs or 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 stop use and seek medical help immediately. 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 doctor promptly.

Common adverse reactions may include excitability, particularly in children, and marked drowsiness. Patients are advised to avoid alcoholic beverages, as well as sedatives and tranquilizers, which may exacerbate drowsiness. Caution is recommended when driving a motor vehicle or operating machinery.

Patients should discontinue use 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 occur, or if a cough returns or occurs with a rash or headache that lasts. These symptoms could indicate a serious condition requiring medical evaluation.

Drug Interactions

Acetaminophen has the potential to increase the risk of liver damage when used concurrently with other medications containing acetaminophen or in individuals consuming three or more alcoholic beverages daily. It is advisable to avoid the combined use of acetaminophen-containing products and to limit alcohol intake to reduce the risk of hepatotoxicity.

Dextromethorphan may interact with monoamine oxidase inhibitors (MAOIs), which can lead to serious adverse effects. It is recommended to avoid the use of dextromethorphan in patients currently taking MAOIs or within two weeks of discontinuing MAOI therapy to prevent potential interactions.

Warfarin, an anticoagulant, may have its anticoagulant effects modified when administered with acetaminophen. It is essential to monitor International Normalized Ratio (INR) levels closely in patients receiving this combination to ensure therapeutic efficacy and safety.

Packaging & NDC

Below are the non-prescription pack sizes of Nighttime Cold and Flu (acetaminophen, dextromethorphan hbr, 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. In children, the use of this medication may lead to excitability. For patients aged 12 years and older, the recommended dosage is 30 mL every 6 hours. In the event of an overdose, it is crucial to seek immediate medical attention for both adults and children, even if no signs or symptoms are apparent.

Geriatric Use

Elderly patients may use this product; however, there are no specific dosage adjustments or safety concerns outlined for this population in the available information. The product is indicated for adults and children aged 12 years and older, suggesting that it may not be appropriate for younger individuals, but it does not provide explicit guidance regarding geriatric patients.

While the warnings section does not specifically address considerations for elderly patients, it is important to note that general warnings related to liver disease, glaucoma, and other medical conditions may be particularly relevant for this demographic. Therefore, healthcare providers should exercise caution and consider these factors when prescribing the product to elderly patients.

Additionally, it is recommended that elderly patients consult with their healthcare provider prior to use, especially if they have existing health conditions. This consultation is crucial to ensure safe and effective use of the product in the context of their overall health status.

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 regarding 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 not been specifically addressed in the drug insert regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the absence of detailed 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 exercise caution when using this product, which contains acetaminophen. It is critical to note that severe liver damage may occur if the total daily dose of acetaminophen exceeds 4,000 mg. Additionally, the risk of severe liver damage increases if acetaminophen is taken concurrently with other medications that also contain acetaminophen.

Patients with compromised liver function are advised to avoid the consumption of three or more alcoholic drinks per day while using this product, as this may further elevate the risk of liver damage. Prior to using this product, patients with a history of liver disease should consult a healthcare professional for guidance.

In the event of an overdose, which may occur if the recommended dosage is exceeded, 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 essential for both adults and children, even in the absence of noticeable signs or symptoms of overdose.

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 to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 without delay.

Prompt medical intervention is essential for both adults and children, even in the absence of noticeable signs or symptoms of overdose. The lack of immediate symptoms does not preclude the risk of significant harm, underscoring the importance of vigilance and proactive management in cases of suspected overdose.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

No specific postmarketing experience details are provided in the insert.

Patient Counseling

Healthcare providers should advise patients about the potential risks associated with overdose, emphasizing that taking more than the recommended dose may lead to liver damage. In the event of an overdose, patients should seek medical help or contact a Poison Control Center (1-800-222-1222) immediately, as prompt medical attention is crucial for both adults and children, even if no signs or symptoms are apparent.

Patients currently taking a prescription monoamine oxidase inhibitor (MAOI) for depression, psychiatric or emotional conditions, or Parkinson’s disease should be informed that they must not use this product while on the MAOI or for two weeks after discontinuing it. If patients are uncertain whether their prescription includes an MAOI, they should be encouraged to consult their 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 non-prescription. Patients should be advised to verify the contents of their medications with a healthcare professional if they are unsure.

Patients should be counseled to discontinue use and consult a doctor if their pain or cough worsens or persists for more than seven days, if their fever worsens or lasts more than three days, if they notice any redness or swelling, or if new symptoms arise. Additionally, they should be informed to seek medical advice if a cough recurs or is accompanied by a rash or headache that lasts, 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. They should be cautioned against consuming alcoholic beverages while using this product, as well as being careful when driving or operating machinery. The combination of this product with alcohol, sedatives, or tranquilizers may enhance drowsiness.

Patients with liver disease, glaucoma, a cough associated with excessive phlegm, or chronic respiratory issues such as asthma, chronic bronchitis, or emphysema should be advised to consult a doctor before using this product. Furthermore, those experiencing difficulty urinating due to an enlarged prostate gland, or those taking sedatives, tranquilizers, or the blood-thinning medication warfarin, should also seek guidance from a healthcare professional 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 20-25ºC (68-77ºF). 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 product 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 use in children under 12 years of age.

Clinicians should counsel patients to consult a health professional if they are pregnant or breastfeeding. It is essential to keep the medication out of reach of children. An overdose may lead to liver damage; therefore, patients should be advised to seek immediate medical assistance or contact a Poison Control Center (1-800-222-1222) if an overdose occurs, regardless of the presence of symptoms.

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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