Nighttime Cherry Cold and Flu

Description

750L Nighttime Cold and Flu Liquid Cherry is presented in a liquid dosage form. The active and inactive ingredients, as well as specific physical characteristics and packaging details, are not provided in the available information.

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 or nonteratogenic effects associated with this drug.

Dosage and Administration

Patients should take the medication only as directed and utilize the dose cup provided for accurate measurement.

For adults and children aged 12 years and older, the recommended dosage is 30 mL every 6 hours, with a maximum of 4 doses within a 24-hour period.

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

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

Contraindications

Use of this product is contraindicated in the following situations:

• Concurrent use 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.

• In patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such treatment. MAOIs are commonly prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. If there is uncertainty about the presence of an MAOI in a prescription medication, a healthcare professional should be consulted prior to use.

Warnings and Precautions

This product contains acetaminophen, which carries specific warnings and precautions that healthcare professionals must communicate to patients to ensure safe use.

Liver Warning Severe liver damage may occur if the patient exceeds the maximum recommended dosage of 4 doses within a 24-hour period. Caution is advised when this product is taken in conjunction with other medications containing acetaminophen. Additionally, patients should be informed that consuming three or more alcoholic drinks daily while using this product increases the risk of liver damage.

Allergy Alert Acetaminophen may lead to severe skin reactions. Symptoms indicative of such reactions include skin reddening, blisters, and rash. Should any of these symptoms occur, patients must be instructed to discontinue use immediately and seek medical assistance.

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

Emergency Medical Help In the event of an overdose, it is imperative to seek emergency medical help or contact a Poison Control Center at 1-800-222-1222 without delay. Quick medical attention is crucial for both adults and children, even if no signs or symptoms are immediately apparent.

When to Stop Taking the Product Patients should be instructed to stop taking this product and consult a healthcare professional if any of the following occur:

• Pain or cough worsens or persists for more than 7 days.

• Fever worsens or lasts more than 3 days.

• Redness or swelling is observed.

• New symptoms develop.

• Cough recurs or occurs alongside a rash or headache that lasts.

Healthcare professionals should ensure that patients are fully aware of these warnings and precautions to promote safe and effective use of the product.

Side Effects

Severe liver damage may occur in patients who exceed the maximum daily dosage of four doses within a 24-hour period, take the product in conjunction with other medications containing acetaminophen, or consume three or more alcoholic drinks daily while using this product.

Patients should be aware that acetaminophen may 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 and seek medical assistance immediately.

In cases where a sore throat is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, patients are advised to consult a healthcare professional promptly.

Additionally, patients should stop use and contact a doctor if any of the following occur: pain or cough worsens or lasts longer than seven days; fever worsens or lasts more than three days; redness or swelling is observed; new symptoms develop; or if a cough recurs or occurs alongside a rash or headache that persists. These symptoms may indicate a serious condition requiring medical evaluation.

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 combination may lead to serious and potentially life-threatening interactions.

Patients should consult a healthcare professional prior to using this medication if they are concurrently taking sedatives or tranquilizers, as these substances may enhance the sedative effects of the medication, leading to increased drowsiness.

Additionally, individuals taking the anticoagulant warfarin should seek advice from a healthcare provider before using this medication, as there may be an increased risk of bleeding or other interactions.

It is important to note that the consumption of alcohol, along with sedatives and tranquilizers, may further increase drowsiness and should be approached with caution. Monitoring for excessive sedation is advised in patients using these combinations.

Packaging & NDC

Below are the non-prescription pack sizes of Nighttime Cherry Cold and Flu (acetaminophen, dextromethorphan hydrobromide, and doxylamine succinate). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 4 to under 12 years should be advised to consult a healthcare professional before use. The medication is not recommended for children under 4 years of age.

Caution is warranted as excitability may occur, particularly in pediatric patients. Additionally, marked drowsiness has been reported, which may impact the safety and efficacy of the treatment in this population.

Geriatric Use

Elderly patients may not require specific dosage adjustments or face unique safety concerns when using this product. However, it is important to note that the product has the potential to cause marked drowsiness, which may be more pronounced in geriatric patients who are often more sensitive to sedative effects.

Due to the risk of drowsiness, elderly patients should exercise caution when driving a motor vehicle or operating machinery. It is advisable for these patients to consult a healthcare provider prior to use, particularly if they have underlying conditions such as liver disease, glaucoma, respiratory issues, or difficulties with urination related to an enlarged prostate gland. Monitoring and careful consideration of these factors are recommended to ensure the safe use of the product in the geriatric 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 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 not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

Hepatic Impairment

Patients with hepatic impairment should exercise caution when using this product, which contains acetaminophen. Severe liver damage may occur if patients exceed the maximum daily amount of 4 doses within a 24-hour period. Additionally, patients must avoid concomitant use with other medications that contain acetaminophen, as this can further increase the risk of liver injury.

It is also important for patients with compromised liver function to limit alcohol consumption. Specifically, the intake of 3 or more alcoholic drinks per day while using this product is contraindicated, as it may exacerbate the risk of severe liver damage.

Monitoring of liver function is recommended for patients with hepatic impairment who are prescribed this product, to ensure safety and mitigate potential adverse effects.

Overdosage

In cases of overdosage, significant health risks are associated with the consumption of this product beyond the recommended limits.

Risk of Severe Liver Damage Healthcare professionals should be aware that severe liver damage may occur if a patient exceeds four doses within a 24-hour period, which is the maximum daily dosage for this product. Additionally, the concomitant use of this product with other medications containing acetaminophen can also lead to severe liver damage.

Furthermore, patients who consume three or more alcoholic beverages daily while using this product are at an increased risk of experiencing severe liver damage.

Recommended Actions In the event of suspected overdosage, it is imperative to assess the patient's liver function and consider immediate medical intervention. Monitoring of liver enzymes and supportive care may be necessary, depending on the severity of the symptoms and the extent of the overdose. Prompt recognition and management are crucial to mitigate potential complications associated with liver injury.

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 the use of acetaminophen. Reports have included severe skin reactions, characterized by symptoms such as skin reddening, blisters, and rash. In the event of a skin reaction, it is advised that the use of acetaminophen be discontinued immediately and medical assistance be sought.

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, it is crucial to seek medical help immediately or contact a Poison Control Center at 1-800-222-1222, as prompt medical attention is essential 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 whether a drug contains acetaminophen, 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 stopped taking an MAOI within the past two weeks. Patients should be encouraged to ask their healthcare provider or pharmacist if they are unsure whether their prescription medication contains an MAOI.

Patients should be advised to discontinue use and consult a doctor if their pain or cough worsens or persists for more than 7 days, if their fever worsens or lasts more than 3 days, if they notice any redness or swelling, or if new symptoms develop. Additionally, they should seek medical advice 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 made aware that excitability may occur, particularly in children, and that marked drowsiness may also be a side effect. They should be cautioned to avoid alcoholic beverages while using this product, as alcohol, sedatives, and tranquilizers can enhance drowsiness. Patients should exercise caution when driving a motor vehicle or operating machinery.

Healthcare providers should recommend that patients consult a doctor before using this product if they have liver disease, glaucoma, a cough accompanied by excessive phlegm, a chronic cough 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 taking sedatives, tranquilizers, or the blood-thinning medication warfarin should consult their doctor or pharmacist before using this product.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers. It is essential to store the product at a temperature not exceeding 25°C. Refrigeration is not recommended. Proper storage conditions must be maintained to ensure the integrity and efficacy of the product.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)