Nighttime Cold and Flu, Nighttime Cold and Flu Liquid Cherry

Description

The product, identified by SPL Code 34089-3, is a liquid formulation designed to alleviate cold and flu symptoms. It contains a combination of active ingredients, specifically acetaminophen, dextromethorphan, and phenylephrine. The inactive ingredients include citric acid, sodium citrate, sodium benzoate, artificial flavor, high fructose corn syrup, water, glycerin, propylene glycol, sodium chloride, potassium sorbate, sucralose, and color additives as applicable. The product is presented in a clear, amber-colored solution with a characteristic flavor, typically packaged in a bottle.

Uses and Indications

This drug is indicated for use in patients as determined by the prescribing healthcare professional. Currently, there are no specific indications or usage details provided.

There are no known teratogenic or nonteratogenic effects associated with this drug. Healthcare professionals should consider the absence of these effects when evaluating treatment options for their patients.

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 should be sought or contact with a Poison Control Center is advised.

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.

Patients should be informed of the potential for severe skin reactions associated with acetaminophen. Symptoms indicative of such reactions may include skin reddening, blisters, and rash. In the event of any skin reaction, 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 healthcare provider without delay.

Emergency medical help should be sought in the event of an overdose. It is crucial for both adults and children to receive prompt medical attention, even if no signs or symptoms are immediately apparent. Healthcare professionals should encourage patients to contact a Poison Control Center or seek medical help right away in such situations.

Patients must be instructed to stop taking the product and contact their healthcare provider if any skin reactions occur or if the sore throat is severe and persists beyond 2 days, especially if 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 should be vigilant. If the sore throat is severe, persists for more than two days, or is accompanied or followed by fever, headache, rash, nausea, or vomiting, it is advised to consult a healthcare professional promptly.

Drug Interactions

Severe liver damage may occur when acetaminophen is co-administered with other medications containing acetaminophen. Healthcare professionals should advise patients to avoid the concurrent use of multiple acetaminophen-containing products to mitigate the risk of hepatotoxicity.

Additionally, the risk of severe liver damage is heightened when acetaminophen is taken in conjunction with the consumption of three or more alcoholic beverages daily. It is recommended that patients limit alcohol intake while using acetaminophen to reduce the potential for liver injury.

No specific drug and laboratory test interactions have been identified in the available data.

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 product is not recommended for children under 4 years of age.

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. 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 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 in 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

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should implement supportive care measures, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

If available, specific antidotes or treatments should be administered as indicated based on the clinical scenario and the substance involved. Consultation with a poison control center or a medical toxicologist may also be beneficial in guiding the management of the overdose.

Documentation of the incident, including the substance involved, the amount ingested, and the time of ingestion, is crucial for effective treatment and follow-up care.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to use. No specific non-teratogenic effects have been identified in the available data. Additionally, there are no detailed findings regarding nonclinical toxicology or animal pharmacology and toxicology provided in the current information.

Postmarketing Experience

Postmarketing experience has identified that acetaminophen may be associated with severe skin reactions. Reports indicate that symptoms can 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 for patients to understand the potential risks and benefits associated with its use during these periods.

Providers should emphasize the necessity of keeping the medication out of reach of children to prevent accidental ingestion. Patients should be informed about the importance of safeguarding medications and ensuring they are stored securely.

In the event of an overdose, healthcare providers must instruct patients to seek immediate medical assistance or contact a Poison Control Center. It is crucial to communicate that quick medical attention is essential for both adults and children, even if no signs or symptoms of overdose are apparent. This proactive approach can help mitigate potential health risks associated with misuse or accidental exposure.

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 if no symptoms are apparent.

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)