Acetaminophen/Dextromethorphan hydrobromide/Doxylamine succinate

Description

Nitetime Cold and Flu is a pharmaceutical product designed for the relief of cold and flu symptoms. The product is presented in an image/jpeg format, with the reference image identified as 418---nitetime-cold-and-flu-relief-1.jpg. The effective date of this product is October 31, 2023.

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 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 indicated for use in children under 4 years of age.

Contraindications

Use of this product is contraindicated in the following situations:

The product should not be used in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription, due to the risk of acetaminophen overdose. Additionally, it is contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing an MAOI, as this may lead to serious drug interactions.

This product is also not intended for use in making a child sleep, and it should not be used in excess of the directed dosage. Consumption of alcoholic beverages should be avoided while using this product.

Warnings and Precautions

This product contains acetaminophen, which carries significant risks that healthcare professionals must communicate to patients.

Liver Warning Severe liver damage may occur if the maximum daily dosage of 4 doses within 24 hours is exceeded. Additionally, the risk increases when acetaminophen is taken concurrently with other medications containing acetaminophen or when consumed with three or more alcoholic drinks daily while using this product.

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, it is imperative 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 is accompanied by fever, headache, rash, nausea, or vomiting, patients should be advised to consult a healthcare provider promptly.

General Precautions Patients should be instructed to consult a doctor prior to use 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.

Furthermore, it is advisable for patients to consult a doctor or pharmacist if they are currently taking sedatives, tranquilizers, or the blood-thinning medication warfarin.

Emergency Medical Help In the event of an overdose, immediate medical attention is crucial. Patients should be directed to contact a Poison Control Center at 1-800-222-1222 without delay, as prompt intervention is essential for both adults and children, even in the absence of noticeable symptoms.

Discontinuation and Consultation Patients should be instructed to stop taking the product and contact their healthcare provider if any of the following occur: pain or cough worsens or persists beyond seven days; fever worsens or lasts more than three days; redness or swelling is observed; new symptoms develop; or if a cough recurs alongside a rash or headache that lasts. 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 daily dosage of four doses within a 24-hour period, use other medications containing acetaminophen concurrently, or consume three 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 any skin reaction, it is imperative to discontinue use and seek medical assistance immediately. Additionally, if 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.

Common adverse reactions may include excitability, particularly in children, and marked drowsiness. Patients are cautioned to avoid alcoholic beverages, as well as sedatives and tranquilizers, which may exacerbate drowsiness. Care should be taken when driving or operating machinery due to the potential for impaired alertness.

Patients should discontinue use and consult a doctor if pain or cough worsens or lasts longer than seven days, if fever worsens or persists beyond three days, if redness or swelling is observed, if new symptoms arise, or if a cough recurs with a rash or headache that lasts, as these may indicate a serious condition.

Before using this product, patients with liver disease, glaucoma, or chronic respiratory conditions such as asthma, chronic bronchitis, or emphysema should seek medical advice. Additionally, those experiencing difficulty urinating due to an enlarged prostate gland, or those taking sedatives, tranquilizers, or the blood-thinning medication warfarin, should consult a healthcare professional prior to use.

Drug Interactions

Co-administration 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) or within 2 weeks of discontinuing an MAOI. This interaction may lead to severe hypertensive reactions.

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, leading to increased drowsiness.

Additionally, caution is advised for patients taking the anticoagulant warfarin. It is recommended that a healthcare provider be consulted before initiating this medication, as interactions may increase the risk of bleeding.

Alcohol, along with sedatives and tranquilizers, may further amplify drowsiness when taken with this medication. Monitoring for excessive sedation is advised in patients consuming these substances concurrently.

Packaging & NDC

Below are the non-prescription pack sizes of Nite Time Cold and Flu Relief. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Children aged 4 to under 12 years should consult a doctor 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. In the event of an overdose, prompt medical attention is essential for both adults and children, even if no signs or symptoms are apparent.

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 potential 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, as the effects on fetal outcomes and breastfeeding infants are not fully established. It is essential for women of childbearing potential to discuss their individual circumstances with a healthcare provider 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 currently no available data regarding the excretion of this medication 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 drug insert regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment should exercise caution when using this product, as it contains acetaminophen, which is associated with the risk of severe liver damage. It is critical that patients do not exceed 4 doses within a 24-hour period, as this represents the maximum daily amount for this product. Additionally, patients should avoid concomitant use with other medications containing acetaminophen, as this can further increase the risk of liver injury.

Patients with compromised liver function are advised to consult a healthcare professional prior to using this product, particularly if they have a history of liver disease. Furthermore, it is recommended that patients limit alcohol consumption to fewer than 3 drinks per day while using this product to mitigate the risk of liver damage. Regular monitoring of liver function may be warranted in patients with existing liver conditions to ensure safety and efficacy during treatment.

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, vigilance and timely action are essential in managing potential overdose situations.

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

There have been reports of severe skin reactions associated with acetaminophen, including 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 immediately.

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, emphasizing the importance of prompt medical attention for both adults and children, even if no signs or symptoms are apparent.

Patients should be instructed not to exceed the recommended dosage. It is important to inform them that excitability may occur, particularly in children, and that marked drowsiness is a possible side effect. Providers should caution patients to avoid alcoholic beverages, as alcohol, sedatives, and tranquilizers can enhance drowsiness.

When discussing safety, healthcare providers should remind patients to exercise caution when driving or operating machinery due to the potential for drowsiness.

Patients should be encouraged to consult with their healthcare provider before use if they have any of the following conditions: liver disease, glaucoma, a cough accompanied by excessive phlegm (mucus), breathing problems, or a chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema. Additionally, patients experiencing difficulty urinating due to an enlarged prostate gland should also seek medical advice prior to use.

Finally, healthcare providers should recommend that patients consult with a doctor or pharmacist if they are currently taking sedatives, tranquilizers, or the blood-thinning medication warfarin, to ensure safe and effective use of the medication.

Storage and Handling

The product is supplied in blister packaging. Each blister unit must be inspected prior to use; do not use if the blister unit is torn or open.

For optimal storage, the product should be maintained at room temperature, specifically within the range of 20-25 °C (68-77 °F). Proper handling and storage conditions are essential to ensure the integrity and efficacy of the product.

Additional Clinical Information

Adults and children aged 12 years and older are advised to take 2 softgels with water every 6 hours. For children aged 4 to under 12 years, consultation with a doctor is recommended, while the product should not be used in children under 4 years of age.

Clinicians should counsel patients to seek advice from a health professional if they are pregnant or breastfeeding. It is important to keep the product out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center (1-800-222-1222) should be contacted, as prompt medical attention is crucial for both adults and children, regardless of the presence of symptoms.

Drug Information (PDF)

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

View product document (PDF)