Nighttime Cold and Flu, Nighttime Cold and Flu Liquid Cherry

Description

No description information is available for the specified drug.

Uses and Indications

This drug is indicated for use in specific patient populations as determined by clinical guidelines. The precise indications and usage have not been explicitly stated in the provided information.

Healthcare professionals are advised to consider the absence of information regarding teratogenic and nonteratogenic effects when prescribing this medication. Further evaluation of the drug's safety profile and clinical efficacy is recommended to ensure appropriate use in targeted patient populations.

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 is contraindicated in the following situations:

Pregnant or breastfeeding individuals should consult a healthcare professional prior to use. The product must be kept out of reach of children to prevent accidental ingestion. In the event of an overdose, immediate medical assistance or contact with a Poison Control Center is required.

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—considering all medications containing acetaminophen—or consuming 3 or more alcoholic drinks daily while using this product significantly increases the risk of liver injury.

Acetaminophen may also lead to severe skin reactions. Symptoms indicative of such reactions include skin reddening, blisters, and rash. In the event of any skin reaction, patients must be instructed to discontinue use immediately and seek medical assistance without delay.

Healthcare providers should be vigilant regarding patients presenting with a sore throat. If the sore throat is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, prompt consultation with a physician is warranted.

For patients who are pregnant or breastfeeding, it is essential to consult a healthcare professional prior to using this product to ensure safety for both the mother and child.

In cases of overdose, immediate medical attention is critical. Patients should be advised to contact a Poison Control Center or seek emergency medical help right away, as timely intervention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Patients must be instructed to stop taking the product and contact their doctor if any skin reactions occur or if a sore throat is severe, persists beyond 2 days, or is accompanied by other concerning symptoms.

Side Effects

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

Patients should be aware of the potential for severe skin reactions associated with acetaminophen. Symptoms may include skin reddening, blisters, and rash. In the event of a skin reaction, it is imperative that patients discontinue use and seek medical assistance immediately.

Additionally, patients experiencing a sore throat that is severe, persists for more than two days, or is accompanied or followed by fever, headache, rash, nausea, or vomiting should consult a healthcare professional promptly.

Drug Interactions

There are currently no documented drug interactions associated with the use of 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, Nighttime Cold and Flu Liquid Cherry (acetaminophen, dextromethorphan, 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 before use. The safety and efficacy of this medication have not been established in children under 4 years of age, and its use is not recommended in this population.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy, 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. 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 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 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 4 doses within a 24-hour period, which is the maximum daily amount for this product. Additionally, patients should be advised against consuming 3 or more alcoholic drinks daily while using this product, as this may further increase the risk of liver damage.

Due to the potential for compromised liver function to affect the metabolism of acetaminophen, healthcare providers should exercise caution and consider individual patient factors when determining the appropriateness of this product for patients with hepatic impairment. Regular assessment of liver function may be warranted in these patients to ensure safety and efficacy.

Overdosage

There is currently no specific information available regarding overdosage for this medication. Healthcare professionals are advised to monitor patients closely for any signs of adverse effects or symptoms that may arise from excessive dosing.

In the event of suspected overdosage, it is recommended that healthcare providers initiate supportive care and symptomatic treatment as necessary. Patients should be evaluated for potential complications, and appropriate interventions should be implemented based on clinical judgment.

For further guidance, healthcare professionals may refer to established protocols for managing drug overdosage or consult a poison control center.

Nonclinical Toxicology

If pregnant or breast-feeding, it is advised to consult a health professional before use. There are no specific non-teratogenic effects or detailed nonclinical toxicology information available. Additionally, no specific animal pharmacology and toxicology details have been provided.

Postmarketing Experience

Acetaminophen has been associated with severe skin reactions, as reported in postmarketing surveillance. Symptoms of these reactions may include skin reddening, blisters, and rash. In the event of a skin reaction, it is advised to discontinue use immediately and seek medical assistance.

Patient Counseling

Healthcare providers should advise patients to consult a health professional if they are pregnant or breastfeeding before using this medication. It is important to emphasize the necessity of keeping the 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. Healthcare providers should stress that quick medical attention is critical for both adults and children, even if no signs or symptoms of overdose are apparent.

Storage and Handling

The product is supplied in a configuration that ensures optimal usability. It should be stored at room temperature to maintain its integrity and effectiveness. It is essential to keep the product out of reach of children to prevent accidental ingestion. Once opened, the product must be discarded to ensure safety and efficacy.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. It is essential to keep the medication out of reach of children. In the event of an overdose, patients should seek immediate medical assistance or contact a Poison Control Center, as prompt attention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Drug Information (PDF)

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

View product document (PDF)