Nighttime Cold and Flu

Description

NIGHTTIME COLD AND FLU CAPSULES are provided in a bulk shipment containing 4000 capsules, identified by NDC No: 53345-026-01. These capsules are intended solely for further manufacturing, processing, or repackaging. Upon receipt, immediate inspection is required to ensure product integrity. The capsules must be protected from heat, humidity, and light, and should not be refrigerated. Recommended storage conditions are between 15-30°C (59-86°F).

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 adhere strictly to the prescribed dosage and administration guidelines. 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 as needed.

For children aged 4 to 12 years, it is advised to consult a healthcare professional for appropriate dosing recommendations.

The use of this product is contraindicated in children under 4 years of age.

When utilizing other nighttime or daytime products, it is essential to carefully review each label to ensure proper dosing and avoid potential overdose.

Contraindications

Use of this product is contraindicated in the following situations:

• Co-administration with any other drug containing acetaminophen, whether prescription or nonprescription, due to the risk of acetaminophen overdose. If uncertain about the presence of acetaminophen in other medications, consult a healthcare professional.

• Concurrent use with prescription monoamine oxidase inhibitors (MAOIs) or within 2 weeks of discontinuing an MAOI, as this may lead to serious drug interactions. If there is uncertainty regarding the presence of an MAOI in a prescription medication, seek advice from a healthcare professional.

• Use in children for the purpose of inducing sleep is contraindicated.

Additionally, do not exceed the recommended dosage and avoid the consumption of alcoholic beverages while 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.

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 instructed to seek medical attention promptly.

Emergency medical assistance is crucial in the event of an overdose. Patients should be advised to contact a Poison Control Center or seek immediate medical help, regardless of whether they exhibit any signs or symptoms of overdose. This is essential for both adults and children.

Patients should discontinue use and consult a healthcare provider if any of the following occur: pain or cough worsens or lasts longer than seven days; fever worsens or persists for 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 liver damage may occur in patients who exceed the maximum daily dosage of four doses within a 24-hour period, take this product in conjunction with other medications containing acetaminophen, or consume three or more alcoholic drinks daily while using this product.

Patients should be advised to seek medical attention if they experience a sore throat that is severe, lasts more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting. Additionally, individuals should discontinue use and consult a healthcare professional if pain or cough worsens or persists beyond seven days, if fever worsens or lasts more than three days, if redness or swelling is observed, if new symptoms arise, or if a cough recurs alongside a rash or headache that lasts. These symptoms may indicate a serious underlying condition.

Before using this product, patients with liver disease, glaucoma, or a cough associated with excessive phlegm should consult a healthcare provider. Those with breathing problems or chronic coughs related to smoking, asthma, chronic bronchitis, or emphysema, as well as individuals experiencing difficulty urinating due to an enlarged prostate gland, should also seek medical advice prior to use.

Furthermore, patients taking sedatives or tranquilizers, or those on the blood-thinning medication warfarin, should consult a doctor or pharmacist before using this product.

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 2 weeks following the discontinuation of an MAOI. This combination may lead to serious and potentially life-threatening interactions.

Patients should consult a healthcare professional before 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 prior to using this medication, as there may be an increased risk of bleeding or other interactions.

It is important to note that the concomitant 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 aged 4 to 12 years should consult a healthcare professional before use. The product is contraindicated in children under 4 years of age. For adults and children aged 12 years and older, the recommended dosage is 2 softgels with water every 6 hours.

Caution is advised as excitability may occur, particularly in children. Additionally, marked drowsiness is a potential side effect that should be considered when administering this product to pediatric patients.

Geriatric Use

Elderly patients may not require specific dosage adjustments when using this medication, as there are no safety concerns or modifications indicated for this population in the provided information. However, healthcare providers should remain vigilant in monitoring for any potential adverse effects, as individual responses to treatment can vary among geriatric patients. It is advisable to consider the overall health status and comorbidities of elderly patients when prescribing this medication to ensure optimal therapeutic outcomes.

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 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 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 exercise caution when using this product, which contains acetaminophen. Severe liver damage may occur if patients exceed the maximum daily amount 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.

It is also advised that patients with compromised liver function limit their alcohol intake to fewer than 3 alcoholic drinks daily while using this product, as alcohol consumption can exacerbate the potential for liver damage. Regular monitoring of liver function may be warranted in patients with existing hepatic impairment to ensure safety and prevent adverse effects.

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 risk of liver damage is heightened when this product is taken concurrently with other medications containing acetaminophen.

Furthermore, patients who consume three or more alcoholic drinks daily while using this product are also at an increased risk for severe liver damage.

Recommended Actions In the event of suspected overdosage, it is imperative to assess the patient's condition promptly. Immediate medical intervention may be necessary, and healthcare providers should consider monitoring liver function tests and providing supportive care as needed. It is crucial to educate patients on the importance of adhering to dosing guidelines and the potential dangers of combining this product with other substances that may exacerbate liver toxicity.

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 compound in these areas.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions reported voluntarily or through surveillance programs.

Allergic reactions have been noted, including cases of anaphylaxis and angioedema. Skin reactions such as rash, urticaria, and pruritus have also been documented. Instances of hepatotoxicity, including acute liver failure, have been reported. Gastrointestinal reactions, including nausea and vomiting, have been observed. Additionally, central nervous system effects, such as dizziness and sedation, have been recorded.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. Patients should be informed that taking more than the directed dose can lead to serious health problems. In the event of an overdose, it is crucial to seek medical help or contact a Poison Control Center immediately, as prompt medical attention is essential for both adults and children, even if no signs or symptoms are present.

Patients should be cautioned against using this product in conjunction with any other medications that contain 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 may use this product to assist with sleep in children; however, they should be advised to stop use and consult a doctor if pain or cough worsens or persists for more than seven days, if fever worsens or lasts more than three days, or if any redness or swelling occurs. Additionally, patients should seek medical advice if new symptoms arise or if a cough returns or occurs alongside a rash or headache that lasts, as these may indicate a serious condition.

While using this product, patients should adhere strictly to the recommended dosage. They should be made aware that excitability may occur, particularly in children, and that marked drowsiness is a possible side effect. Patients should be advised to avoid alcoholic beverages, as well as to exercise caution when driving or operating machinery, given the potential for increased drowsiness when combined with alcohol, sedatives, or tranquilizers.

Patients with liver disease, glaucoma, a cough accompanied by excessive phlegm, or breathing problems such as chronic cough, asthma, chronic bronchitis, or emphysema should consult a doctor before using this product. Additionally, those experiencing difficulty urinating due to an enlarged prostate gland, or those taking sedatives, tranquilizers, or the blood-thinning medication warfarin, should also seek guidance from their healthcare provider or pharmacist prior to use.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It should be stored at room temperature, within the range of 15° to 30°C (59° to 86°F). Care should be taken to ensure that the product is kept in a suitable container to maintain its integrity. Special handling requirements should be observed to prevent exposure to extreme temperatures or conditions that may compromise the product's quality.

Additional Clinical Information

The medication is administered orally. Clinicians should counsel patients to consult a doctor prior to use if they have liver disease, glaucoma, a cough with excessive phlegm, or any breathing issues related to smoking, asthma, chronic bronchitis, or emphysema. Additionally, patients experiencing difficulty urinating due to an enlarged prostate should seek medical advice. It is also recommended that patients inform their healthcare provider if they are taking sedatives, tranquilizers, or the blood-thinning medication warfarin. Pregnant or breastfeeding individuals should consult a health professional before using this medication.

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)