Nighttime Cold and Flu

Description

Acetaminophen, at a dosage of 650 mg, serves as a pain reliever and fever reducer. The formulation also includes Dextromethorphan HBr, a cough suppressant, at a concentration of 30 mg, and Diphenhydramine Succinate, an antihistamine, at 12.5 mg. The product is flavored with cherry and contains 10% alcohol.

Uses and Indications

This drug is indicated for the temporary relief of common cold and flu symptoms, including minor aches and pains, headache, fever, sore throat, runny nose, sneezing, and cough due to minor throat and bronchial irritation.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Healthcare professionals should advise patients to adhere strictly to the recommended dosage to avoid the risk of overdose. 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 30 mL every 6 hours as needed. It is imperative that the dosing cup provided with the product is used for measurement; no other dosing devices should be utilized to ensure accurate dosing. The dosing cup should be kept with the product at all times to facilitate proper administration.

Children under 12 years of age should not use this product. When patients are using other Day Time or Night Time products, they must carefully read each label to confirm the correct dosing and avoid exceeding the recommended limits.

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) for depression, psychiatric or emotional conditions, or Parkinson’s disease, and for a period of 2 weeks following the discontinuation of the MAOI. This is due to the potential for serious drug interactions. If there is uncertainty about whether a prescription drug contains an MAOI, a healthcare professional should be consulted prior to use.

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 patient exceeds 4,000 mg of acetaminophen within a 24-hour period, uses other medications containing acetaminophen concurrently, or consumes three or more alcoholic drinks daily while using this product. It is crucial to monitor patients for signs of liver dysfunction, particularly in those who may be at higher risk.

Allergy Alert Acetaminophen may induce severe skin reactions, which can manifest as skin reddening, blisters, or rash. If any of these symptoms occur, patients should be advised to discontinue use immediately and seek medical assistance.

Sore Throat Warning Patients experiencing a severe sore throat that persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, should be instructed to consult a physician promptly.

General Precautions Healthcare professionals should advise patients to consult a doctor before using this product if they have any of the following conditions: liver disease, glaucoma, a cough associated with excessive phlegm, breathing problems, chronic cough related to smoking, asthma, chronic bronchitis, emphysema, or difficulty urinating due to an enlarged prostate gland. Additionally, patients should be cautioned to seek advice from a doctor or pharmacist if they are taking sedatives, tranquilizers, or the anticoagulant warfarin.

Emergency Medical Help In the event of an overdose, immediate medical attention is essential. Patients should be instructed to contact a Poison Control Center (1-800-222-1222) or seek emergency medical help right away, even if no symptoms are apparent, as prompt intervention is critical for both adults and children.

Discontinuation of Use Patients should be advised to stop taking this product and consult a doctor if they experience any of the following: worsening pain or cough lasting more than seven days, the emergence of new symptoms, fever that worsens or persists for more than three days, presence of redness or swelling, or a cough that recurs or is accompanied by a rash or headache lasting longer than expected. These symptoms may indicate a serious underlying condition that requires further evaluation.

Side Effects

Severe liver damage may occur in patients taking this product containing acetaminophen if they exceed 4,000 mg in 24 hours, use other medications containing acetaminophen concurrently, or consume three or more alcoholic drinks daily while using this product. Patients should be aware of the potential for severe skin reactions, which may 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.

Participants should also be cautious of the possibility of excitability, particularly in children, and marked drowsiness may occur. It is advised to avoid alcoholic beverages, as well as sedatives and tranquilizers, which may exacerbate drowsiness. Patients are urged to exercise caution when driving or operating machinery.

Patients should stop use and consult a healthcare professional if pain or cough worsens or persists beyond 7 days, if new symptoms arise, if fever intensifies or lasts more than 3 days, if redness or swelling is observed, or if a cough recurs with a rash or headache that lasts. These symptoms could indicate a serious condition.

In cases of overdose, which may result from exceeding the recommended dosage, patients are at risk for liver damage. Immediate medical attention is crucial for both adults and children, even if no signs or symptoms are initially apparent. In such instances, contacting a Poison Control Center (1-800-222-1222) is strongly recommended.

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 an MAOI. This interaction may lead to serious and potentially life-threatening side effects.

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 due to potential interactions.

It is important to note that the combined use of alcohol, sedatives, and tranquilizers with this medication may further increase drowsiness, necessitating caution in activities requiring alertness.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 12 years of age should not use this product. For adolescents aged 12 years and older, the recommended dosage is 30 mL every 6 hours.

Healthcare professionals should be aware that excitability may occur, particularly in children, and marked drowsiness is a potential side effect. In the event of an overdose, prompt medical attention is essential for both adults and children, even if no signs or symptoms are immediately apparent.

Geriatric Use

Elderly patients may not require specific dosage adjustments or face unique safety concerns when using this product, as no such information is provided in the prescribing information. The product is indicated for adults and children aged 12 years and older, suggesting that it may not be appropriate for younger populations, but it does not offer explicit guidance regarding its use in geriatric patients.

While the warnings section does not specifically address considerations for elderly patients, it does note the potential for marked drowsiness, which could pose a risk for this population. Therefore, healthcare providers should exercise caution and monitor elderly patients for signs of excessive sedation or impaired cognitive function.

Additionally, it is recommended that patients consult a healthcare professional prior to use if they have existing health conditions. Although there is no specific mention of geriatric patients in this context, it remains prudent for healthcare providers to evaluate the overall health status of elderly patients before initiating treatment.

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 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 should consult a healthcare professional prior to use, particularly if they experience difficulties with urination due to an enlarged prostate gland. It is essential to assess renal function and consider potential dosing adjustments or monitoring requirements based on the degree of kidney impairment.

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 4,000 mg of acetaminophen in a 24-hour period, particularly if they are taking other medications that contain acetaminophen or consuming three or more alcoholic drinks daily while using this product.

Patients with a history of liver disease are advised to consult a healthcare professional prior to use. In the event of an overdose, which is defined as taking more than the recommended dose, patients may be at risk for liver damage. Immediate medical assistance should be sought, or contact with a Poison Control Center (1-800-222-1222) is recommended. Prompt medical attention is critical for both adults and children, even if no signs or symptoms of overdose are apparent.

Overdosage

In the event of an overdose, it is crucial to recognize that exceeding the recommended dosage may lead to significant liver damage. Healthcare professionals should be aware that immediate medical intervention is essential.

Recommended Actions In cases of suspected overdose, it is imperative to seek medical assistance without delay. Healthcare providers should advise patients or caregivers to contact a Poison Control Center at 1-800-222-1222 for guidance. Prompt medical attention is critical for both adults and children, even in the absence of noticeable signs or symptoms of overdose.

Potential Symptoms While specific symptoms of overdose may not always be evident, the risk of liver damage underscores the importance of vigilance and timely intervention.

Management Procedures Upon recognition of an overdose, healthcare professionals should initiate appropriate management protocols, which may include monitoring liver function and providing supportive care as necessary. The involvement of poison control experts can further assist in determining the best course of action based on the specific circumstances of the overdose.

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 that acetaminophen may be associated with severe skin reactions, which can manifest as skin reddening, blisters, or rash. In the event of a skin reaction, it is advised to discontinue use and seek medical assistance immediately.

Additionally, excitability has been reported, particularly in pediatric patients, and marked drowsiness may occur. The concomitant use of alcohol, sedatives, or tranquilizers may exacerbate drowsiness.

Healthcare professionals should be alerted if any of the following occur: worsening pain or cough lasting more than 7 days, the emergence of new symptoms, fever that worsens or persists beyond 3 days, presence of redness or swelling, or a cough that recurs or is accompanied by a rash or headache lasting longer than usual. These symptoms may indicate a serious underlying condition.

Furthermore, an overdose warning is in place, as exceeding the recommended dosage may lead to liver damage. In cases of suspected overdose, immediate medical attention is crucial for both adults and children, even if no signs or symptoms are apparent. Contacting a Poison Control Center (1-800-222-1222) is recommended for guidance.

Patient Counseling

Healthcare providers should advise patients about the potential risks associated with overdose, emphasizing that taking more than the recommended dose may lead to liver damage. In the event of an overdose, patients should seek medical help or contact a Poison Control Center (1-800-222-1222) immediately, as prompt medical attention is crucial for both adults and children, even if no signs or symptoms are apparent.

Patients should be instructed 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 inform patients that this product should not be used if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or within two weeks of stopping such medication. 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 seven days. They should also seek medical advice if new symptoms arise, if fever worsens or lasts more than three days, or if there is any redness or swelling. Additionally, patients should be informed that if a cough returns or occurs with a rash or headache that lasts, they should seek medical attention, as these may indicate a serious condition.

When using this product, patients may experience excitability, particularly in children, as well as marked drowsiness. Therefore, they should be cautioned against consuming alcoholic beverages while using this product, as alcohol, sedatives, and tranquilizers can enhance drowsiness. Patients should also be advised to 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, or any breathing problems such as chronic cough, smoking-related issues, asthma, chronic bronchitis, or emphysema. Additionally, patients with 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 various package configurations, with specific NDC numbers available for identification. It is essential to store the product at a temperature range of 20-25ºC (68-77ºF). Refrigeration is not recommended, as it may compromise the integrity of the product. Proper handling and storage conditions must be adhered to in order to maintain the product's efficacy and safety.

Additional Clinical Information

The medication is administered orally, with a recommended dosage of 30 mL every 6 hours for adults and children aged 12 years and older. It is contraindicated for use in children under 12 years of age. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. Additionally, it is important to keep the medication out of reach of children. No further information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

Drug Information (PDF)

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

View product document (PDF)