Nighttime Cherry Cold and Flu

Description

No relevant information is available for SPL code 34089-3.

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. 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 30 mL every 6 hours. For children aged 4 to under 12 years, it is advised to consult a healthcare professional for appropriate dosing. The medication is not recommended for children under 4 years of age.

Contraindications

Use of this product is contraindicated in the following situations:

Patients should not use this product in conjunction with any other medication containing acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in a medication, consultation with a healthcare professional is advised.

Additionally, this product is contraindicated in individuals currently taking a prescription monoamine oxidase inhibitor (MAOI) for conditions such as depression, psychiatric or emotional disorders, or Parkinson's disease, as well as for a period of 2 weeks following the discontinuation of an MAOI. Patients should verify with a healthcare professional if their prescription medication contains an MAOI before using this product.

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 recommended dosage guidelines. Specifically, patients must not exceed 4 doses within a 24-hour period, which is the maximum daily amount. Caution is also warranted when this product is used in conjunction with other medications containing acetaminophen, as this can increase the risk of liver injury. Additionally, patients should be informed that consuming three or more alcoholic drinks daily while using this product may further elevate the risk of liver damage.

Acetaminophen has been associated with severe skin reactions. Symptoms indicative of such reactions may 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 advised to consult a healthcare provider promptly.

Patients should be instructed to stop using the product and seek medical advice if any of the following occur: pain or cough worsens or lasts longer than seven days; fever worsens or persists beyond three days; redness or swelling develops; new symptoms arise; or if a cough recurs or is accompanied by a rash or headache lasting longer than usual. These symptoms may indicate a serious underlying condition that requires further evaluation.

In the event of an overdose, immediate medical attention is essential. Patients should be directed to contact a Poison Control Center at 1-800-222-1222 or seek emergency medical help without delay, even if no signs or symptoms are apparent. Prompt intervention is critical for both adults and children in such situations.

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 this product, particularly if patients exceed the maximum recommended dosage of 4 doses in 24 hours, take it in conjunction with other medications containing acetaminophen, or consume 3 or more alcoholic drinks daily while using this product.

Additionally, acetaminophen may cause severe skin reactions, which can manifest as skin reddening, blisters, or rash. If any of these symptoms occur, patients are advised to discontinue use immediately and seek medical assistance.

Patients should also be cautious regarding sore throat symptoms. If a sore throat is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, it is recommended that they consult a healthcare professional promptly.

Furthermore, patients should stop using the product and consult a doctor if pain or cough worsens or lasts more than 7 days, if fever worsens or lasts more than 3 days, if redness or swelling is present, if new symptoms develop, or if a cough recurs or occurs with 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 conditions such as depression, psychiatric disorders, or Parkinson's disease, and for a period of two 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 amplify drowsiness and should be approached with caution.

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 consult a healthcare professional prior to use. The product is contraindicated in children under 4 years of age. Caution is advised as excitability may occur, particularly in pediatric patients.

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 considered in these populations to ensure the safety of both the mother and the fetus or infant.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no specific data available regarding the excretion of this medication in breast milk or its effects on breastfed infants. Therefore, caution is recommended when considering the use of this medication during lactation.

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 be closely monitored when using this product, which contains acetaminophen. It is important to note that severe liver damage may occur if patients exceed the maximum daily dosage of 4 doses within a 24-hour period. Additionally, patients should avoid concomitant 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. Specifically, the intake of 3 or more alcoholic drinks per day while using this product may significantly heighten the risk of liver damage. Therefore, careful consideration of liver function and adherence to recommended dosing guidelines is essential to minimize the potential for adverse effects in this patient population. Regular monitoring of liver function tests may be warranted in patients with known hepatic impairment to ensure safety and efficacy during treatment.

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 amount 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 drinks 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 overdosage. 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 several adverse reactions associated with the use of acetaminophen. Notably, severe skin reactions have been reported, which include 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 should be sought without delay.

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 present.

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 stopped taking one within the last 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 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 arise. 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 is a possible side effect. They 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. The use of alcohol, sedatives, and tranquilizers may further enhance drowsiness.

Patients should be encouraged to 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. Additionally, those experiencing difficulty urinating due to an enlarged prostate gland should seek medical advice prior to use. Finally, patients taking sedatives, tranquilizers, or the blood-thinning medication warfarin should also consult their healthcare provider 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)