Nighttime Cold/Flu Relief

Description

No description information is available for the specified drug.

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 effects associated with this drug. Additionally, no nonteratogenic effects have been reported.

Dosage and Administration

Patients should adhere strictly to the prescribed dosage and administration guidelines. It is imperative not to exceed four doses within a 24-hour period.

For adults and children aged 12 years and older, the recommended dosage is two soft gels taken with water every six hours as needed.

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

The product is not intended for use in children under 4 years of age.

When utilizing other Daytime or Nighttime 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:

• Concurrent use with any other products 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.

• In patients currently taking a prescription Monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such medication, as this may lead to serious interactions. If there is uncertainty regarding the presence of an MAOI in a prescription drug, seek guidance from a healthcare professional.

• For the purpose of inducing sleep in children, as this use is not recommended.

Additionally, while using this product, do not exceed the recommended dosage or consume alcoholic beverages, as these actions may exacerbate side effects.

Warnings include the potential for excitability, particularly in children, and the possibility of marked drowsiness. Caution is advised when driving or operating machinery, as alcohol, sedatives, and tranquilizers may enhance drowsiness.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen. Healthcare professionals should advise patients that exceeding 4 doses within a 24-hour period, the maximum daily amount for this product, or concurrent use with other medications containing acetaminophen can significantly increase the risk of liver injury. Additionally, consumption of 3 or more alcoholic drinks daily while using this product may further exacerbate this risk.

Acetaminophen has been associated with severe skin reactions, which may manifest as skin reddening, blisters, or rash. If any of these symptoms occur, patients should be instructed to discontinue use immediately and seek medical assistance.

In cases of severe sore throat, particularly if it persists for more than 2 days or is accompanied by fever, headache, rash, nausea, or vomiting, patients should be advised to consult a healthcare provider promptly.

Patients should be instructed to stop taking the product and contact a healthcare professional 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 is accompanied by a rash or headache lasting beyond a short duration. These symptoms may indicate a serious underlying condition that requires medical evaluation.

In the event of an overdose, immediate medical attention should be sought, or the local Poison Control Center should be contacted without delay.

No specific laboratory tests are recommended for monitoring the use of this product. However, healthcare professionals should remain vigilant for signs of adverse reactions and liver function impairment in patients using acetaminophen-containing products.

Side Effects

Severe adverse reactions associated with this product include significant liver damage, which may occur if patients exceed four doses within a 24-hour period, use other medications containing acetaminophen concurrently, or consume three or more alcoholic drinks daily while using this product.

Patients should be aware of the potential for severe skin reactions, which may manifest as skin reddening, blisters, or rash. In the event of any skin reaction, it is imperative to discontinue use and seek medical assistance immediately.

Additionally, a sore throat warning is in place; 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 professional promptly.

Participants in clinical trials and postmarketing experiences have indicated that patients should stop use and consult a doctor if pain or cough worsens or lasts longer than seven days, if fever worsens or lasts more than three days, if redness or swelling is observed, if new symptoms arise, or if a cough recurs with a rash or headache that persists. These symptoms may indicate a serious underlying condition.

Patients are advised to seek medical advice before using this product if they have liver disease, glaucoma, a cough accompanied by excessive phlegm, or any breathing problems, including chronic coughs related to smoking, asthma, chronic bronchitis, or emphysema. Furthermore, individuals experiencing difficulty urinating due to an enlarged prostate gland should also consult a healthcare provider prior to use.

It is recommended that patients consult a doctor or pharmacist before using this product if they are currently taking sedatives or tranquilizers, or if they are on the blood-thinning medication warfarin.

Drug Interactions

There are currently no documented drug interactions associated with 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/Flu Relief (acetaminophen, dextromethorphan hbr, doxylamine succinate). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 4 years of age should not use this medication. For children aged 4 to under 12 years, it is advised to consult a healthcare professional before use.

For adolescents and adults aged 12 years and older, the recommended dosage is 2 soft gels every 6 hours with water, not to exceed 4 doses in a 24-hour period.

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. The potential risks and benefits must be carefully weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice 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 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 available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring of these patients.

Hepatic Impairment

Patients with hepatic impairment should be closely monitored when using this product, which contains acetaminophen. It is critical to adhere to the maximum daily dosage of 4 doses within a 24-hour period to prevent severe liver damage. Additionally, patients should be advised against the concurrent use of other medications containing acetaminophen, as well as the consumption of 3 or more alcoholic drinks daily while using this product. These precautions are essential to mitigate the risk of exacerbating liver function and to ensure patient safety. Regular assessment of liver function may be warranted in patients with compromised liver health to monitor for any potential adverse effects.

Overdosage

In the event of an accidental overdose, it is imperative to seek immediate medical assistance or contact a Poison Control center without delay. Prompt medical intervention is crucial for both adults and children, regardless of whether any signs or symptoms are apparent.

Healthcare professionals should be aware that the absence of symptoms does not preclude the possibility of serious complications arising from an overdose. Therefore, vigilance and swift action are essential in managing such situations to ensure patient safety and effective treatment.

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 several adverse reactions associated with the use of this product. Severe skin reactions, including skin reddening, blisters, and rash, have been reported in association with acetaminophen use. In the event of a skin reaction, users are advised to discontinue use and seek medical assistance immediately.

Additionally, reports of excitability, particularly in children, have been noted. Users may also experience marked drowsiness, which can be exacerbated by the concurrent use of alcohol, sedatives, or tranquilizers. New symptoms may arise during treatment; if this occurs, users should stop use and consult a healthcare professional.

Serious conditions may be indicated by worsening pain or cough lasting more than 7 days, fever persisting for more than 3 days, redness or swelling, or the recurrence of cough accompanied by rash or headache. In cases of overdose, prompt medical attention is essential for both adults and children, even if no signs or symptoms are immediately apparent.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. In the event of an overdose, patients should be instructed to seek medical help or contact a Poison Control Center immediately.

Patients must be cautioned against using this product in conjunction with any other medications that contain acetaminophen, whether prescription or nonprescription. If patients are uncertain whether a drug contains acetaminophen, they should be encouraged to consult with a doctor or pharmacist.

It is important to inform patients that this product should not be used if they are currently taking a prescription Monoamine oxidase inhibitor (MAOI) or within two weeks of stopping such medication. Patients should be advised to check with their healthcare provider if they are unsure whether their prescription includes an MAOI.

Patients should be warned not to use this medication to induce sleep in children. They should be instructed to discontinue use and consult a doctor if their pain or cough worsens or persists for more than seven days, if fever worsens or lasts more than three days, or if they notice any redness or swelling. Additionally, patients should seek medical advice if new symptoms arise or if a cough returns or occurs alongside a rash or headache that lasts, as these may indicate a serious condition.

When using this product, patients should be reminded to adhere strictly to the recommended dosage and not exceed it. 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 accompanied by excessive phlegm, or breathing problems such as chronic cough, asthma, chronic bronchitis, or emphysema should be encouraged to consult a doctor before using this product. Additionally, 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 room temperature, maintaining a range of 20-25º C (68-77º F). Care should be taken to avoid exposure to excessive heat, as this may compromise the integrity of the product. Proper storage conditions are crucial to ensure the product's efficacy and safety.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)