Nighttime Cold and Flu Relief

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 cough due to minor throat and bronchial irritation, sore throat, headache, minor aches and pains, fever, runny nose, and sneezing.

There are no teratogenic or nonteratogenic effects mentioned in the available data.

Dosage and Administration

Patients should take the medication only as directed. 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.

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

The medication is not recommended for use in children under 4 years of age.

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), which are utilized for the treatment of depression, psychiatric or emotional conditions, or Parkinson’s disease, is contraindicated. This includes a prohibition on use for a period of 2 weeks following the discontinuation of MAOIs. Patients should verify with a healthcare professional if their prescription medications contain MAOIs.

• The product should not be used to induce sleep in children.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen. Healthcare professionals should advise patients to adhere strictly to the following guidelines to minimize the risk of liver injury: do not exceed 4 doses within a 24-hour period, avoid concurrent use with other medications containing acetaminophen, and limit alcohol consumption to fewer than 3 alcoholic drinks per day while using this product.

Acetaminophen may also lead to severe skin reactions. Symptoms indicative of such reactions include skin reddening, blisters, and rash. Should any of these symptoms occur, patients must 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 physician without delay.

General precautions should be taken prior to use. Patients should be instructed to consult a healthcare provider if they have a history of liver disease, glaucoma, a cough associated with excessive phlegm, or any breathing problems, including chronic coughs related to smoking, asthma, chronic bronchitis, or emphysema. Additionally, those experiencing difficulty urinating due to an enlarged prostate gland should seek medical advice before use. It is also prudent for patients to discuss their use of sedatives, tranquilizers, or the blood-thinning medication warfarin with their doctor or pharmacist prior to initiating treatment.

In the event of an overdose, immediate medical attention is essential. Patients should be instructed to contact a Poison Control Center (1-800-222-1222) or seek emergency medical help right away, as prompt intervention is critical for both adults and children, even in the absence of noticeable symptoms.

Patients should discontinue use and consult a healthcare professional if any of the following occur: pain worsens or persists beyond 7 days, fever intensifies or lasts more than 3 days, redness or swelling develops, new symptoms arise, or if a cough recurs or is accompanied by a rash or headache lasting longer than expected. These symptoms may indicate a serious underlying condition that requires further evaluation.

Side Effects

Severe adverse reactions associated with this product include the potential for severe liver damage, particularly in patients who exceed the maximum recommended dosage of 4 doses in 24 hours, use other medications containing acetaminophen concurrently, or consume 3 or more alcoholic drinks daily while using this product.

Patients should be aware of the risk of severe skin reactions, which may manifest as skin reddening, blisters, or rash. In the event of a skin reaction, it is imperative to discontinue use and seek medical assistance immediately. Additionally, if a sore throat is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, patients are advised to consult a healthcare professional promptly.

Common adverse reactions may include excitability, particularly in children, and marked drowsiness. Patients are cautioned to avoid alcoholic beverages while using this product, as alcohol, sedatives, and tranquilizers may exacerbate drowsiness. Care should be taken when driving or operating machinery.

Patients should discontinue use and consult a doctor if pain worsens or lasts more than 7 days, fever worsens or lasts more than 3 days, redness or swelling occurs, new symptoms develop, or if a cough recurs or is accompanied by a rash or headache lasting longer than expected, as these may indicate a serious condition.

Before using this product, patients with liver disease, glaucoma, chronic cough with excessive phlegm, or breathing problems such as asthma, chronic bronchitis, or emphysema should seek medical advice. Those experiencing difficulty urinating due to an enlarged prostate gland should also consult a healthcare provider. Furthermore, patients taking sedatives, tranquilizers, or the blood-thinning medication warfarin should discuss their use of this product with a doctor or pharmacist.

In the event of an overdose, immediate medical attention is crucial. Patients should contact a Poison Control Center (1-800-222-1222) without delay, as prompt intervention is essential for both adults and children, even in the absence of noticeable signs or symptoms.

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 and Flu Relief (acetaminophen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 4 to under 12 years should consult a healthcare professional before use. The product is not recommended for children under 4 years of age. Caution is advised as excitability may occur, particularly in pediatric patients.

Geriatric Use

Elderly patients, defined as those aged 65 and older, should consult a healthcare provider prior to using this medication, particularly if they have underlying conditions such as liver disease or glaucoma. While there are no specific recommendations or dosage adjustments outlined for geriatric patients, it is essential for healthcare providers to exercise caution and consider individual patient factors when prescribing this medication to the elderly population.

The prescribing information does not explicitly address safety concerns or special precautions for elderly patients; therefore, careful monitoring and assessment of the patient's overall health status are advised.

Pregnancy

Pregnant patients should consult a healthcare professional prior to using this medication. The safety of this drug during pregnancy has not been established, and potential risks to fetal outcomes are not fully understood. Therefore, it is essential for women of childbearing potential to seek medical advice to weigh the benefits and risks before initiating treatment.

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.

Hepatic Impairment

Patients with hepatic impairment should be aware that this product contains acetaminophen, which carries a risk of severe liver damage. It is critical that patients do not exceed 4 doses within a 24-hour period, as this is the maximum daily amount for this product. Additionally, patients must avoid the concurrent use of other medications containing acetaminophen, as this can further increase the risk of liver injury.

Patients with compromised liver function are also advised to limit alcohol consumption to fewer than 3 alcoholic drinks per day while using this product, as excessive alcohol intake can exacerbate the potential for liver damage.

Before using this product, patients with a history of liver disease should consult a healthcare professional to assess the appropriateness of use and to discuss any necessary dosage adjustments or monitoring requirements.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222. 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. Therefore, it is essential to monitor the patient closely and provide appropriate care as needed.

Nonclinical Toxicology

Teratogenic effects have not been specifically documented; however, it is advised to consult a health professional prior to use.

Non-teratogenic effects may include increased excitability, particularly in pediatric populations, as well as significant drowsiness. The concomitant use of alcohol, sedatives, and tranquilizers may exacerbate drowsiness.

No specific information is available regarding carcinogenicity, mutagenicity, or impairment of fertility. Additionally, there is no detailed data provided concerning animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions: severe skin reactions, which may include symptoms such as skin reddening, blisters, and rash. In cases where a skin reaction occurs, it is advised to discontinue use and seek medical assistance promptly.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center (1-800-222-1222) in the event of an overdose, as prompt medical attention is crucial for both adults and children, even if no signs or symptoms are apparent.

Patients should be informed not to use this product in conjunction with any other medications containing acetaminophen, whether prescription or nonprescription. If patients are uncertain about the presence of acetaminophen in their medications, they should consult a doctor or pharmacist for clarification.

It is important to instruct patients not to use this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have taken one within the past two weeks. Patients should be encouraged to ask their healthcare provider or pharmacist if they are unsure whether their prescription includes an MAOI.

Patients should be cautioned against using this product to induce sleep in children. They should also be advised to discontinue use and consult a doctor if their pain worsens or persists beyond 7 days, if their fever worsens or lasts more than 3 days, if they notice any redness or swelling, or if new symptoms arise. Additionally, patients should be instructed to seek medical advice if a cough recurs or is accompanied by a rash or persistent headache, as these may indicate a serious condition.

When using this product, patients may experience excitability, particularly in children, as well as marked drowsiness. Therefore, they should be advised to avoid alcoholic beverages and to exercise caution when driving or operating machinery. Patients should also be informed that the use of alcohol, sedatives, and tranquilizers may enhance drowsiness.

Healthcare providers should recommend that patients consult a doctor before using this product if they have liver disease, glaucoma, a cough associated with excessive phlegm, or any breathing problems, including chronic coughs related to smoking, asthma, chronic bronchitis, or emphysema. Patients experiencing difficulty urinating due to an enlarged prostate gland should also seek medical advice prior to use. Furthermore, patients should be encouraged to consult a doctor or pharmacist if they are taking sedatives, tranquilizers, or the blood-thinning medication warfarin.

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 20-25 °C (68-77 °F). Proper storage conditions are crucial to ensure the integrity and efficacy of the product.

Additional Clinical Information

Patients should be informed that the medication is administered orally, with the recommended dosage for adults and children aged 12 years and older being 2 softgels taken with water every 6 hours. For children aged 4 to under 12 years, it is advised to consult a doctor, while the product is not recommended for children under 4 years of age.

Clinicians should counsel patients to seek medical advice before use if they have liver disease, glaucoma, a cough with excessive phlegm, breathing problems, chronic cough associated with smoking, asthma, chronic bronchitis, emphysema, or difficulty urinating due to an enlarged prostate. Additionally, patients taking sedatives, tranquilizers, or the blood-thinning medication warfarin should consult a healthcare professional prior to use. While using this product, patients may experience excitability, particularly in children, and marked drowsiness may occur; therefore, it is advised to avoid alcohol and be cautious when driving or operating machinery. Patients should discontinue use and consult a doctor if pain worsens or persists beyond 7 days, fever lasts more than 3 days, or if new symptoms arise, as these may indicate a serious condition. Pregnant or breastfeeding patients should also seek professional advice before use.

Drug Information (PDF)

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

View product document (PDF)