Night Cold Flu Cough and Allergy

Description

NIGHTTIME COLD AND FLU CAPSULES are provided in a bulk shipment containing 4000 capsules. The product is identified by the National Drug Code (NDC) number 53345-020-01. It is essential to inspect the shipment immediately upon receipt. This product is intended solely for further manufacturing, processing, or repacking. Proper storage conditions must be maintained; the capsules should be protected from heat, humidity, and light, and refrigeration is not recommended.

Uses and Indications

This drug is indicated for the temporary relief of symptoms associated with the common cold or influenza, including minor aches and pains, headache, nasal and sinus congestion, cough, sore throat, runny nose, and sneezing. Additionally, it is indicated for the temporary reduction of fever.

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

Dosage and Administration

Adults and children 12 years of age and over are advised to take 2 softgels with water every 4 hours as needed. The total daily dosage must not exceed 10 softgels within a 24-hour period, unless otherwise directed by a healthcare professional.

For children under 12 years of age, the use of this medication is not recommended. It is imperative that patients adhere to the recommended dosing guidelines to avoid potential adverse effects.

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. Verify the presence of MAOIs in prescription medications with a healthcare provider if unsure.

• History of allergic reactions to this product or any of its ingredients, as this may result in severe hypersensitivity reactions.

• Use in children under 12 years of age is contraindicated due to safety concerns.

Warnings and Precautions

This product contains acetaminophen, which poses a risk of severe liver damage if the following conditions are met: exceeding 10 softgels within a 24-hour period, concurrent use with other medications containing acetaminophen, or consumption of three or more alcoholic drinks daily while using this product.

In cases of severe sore throat that persists for more than two days, or if accompanied by fever, headache, rash, nausea, or vomiting, it is imperative to consult a healthcare professional promptly. Additionally, this product is not intended for use as a sedative in children.

Healthcare professionals should advise patients to seek medical guidance prior to use if they have any of the following conditions: liver disease, heart disease, high blood pressure, thyroid disease, diabetes, glaucoma, cough with excessive phlegm, breathing problems such as emphysema or chronic bronchitis, difficulty urinating due to prostate enlargement, or persistent cough associated with smoking, asthma, or emphysema. Furthermore, patients should consult a doctor or pharmacist before use if they are currently taking the anticoagulant warfarin or any sedatives or tranquilizers.

In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center without delay. Rapid medical intervention is crucial for both adults and children, even in the absence of noticeable symptoms.

Patients should discontinue use and contact their healthcare provider if any of the following occur: worsening pain, cough, or nasal congestion lasting more than seven days; fever worsening or persisting beyond three days; presence of redness or swelling; emergence of new symptoms; recurrence of cough accompanied by rash or headache; or the onset of nervousness, dizziness, or sleeplessness.

Side Effects

Severe liver damage may occur in patients who exceed the maximum daily dosage of 10 softgels within a 24-hour period, take the product in conjunction with other drugs containing acetaminophen, or consume three or more alcoholic drinks daily while using this product. Patients should be advised to consult a doctor promptly if they experience a severe sore throat that persists for more than two days, or if it is accompanied or followed by fever, headache, rash, nausea, or vomiting.

This product is contraindicated in patients who are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have taken one within the past two weeks, as well as in those with a known allergy to this product or any of its ingredients. It should not be used in children under 12 years of age. Patients with liver disease, heart disease, high blood pressure, thyroid disease, diabetes, glaucoma, cough with excessive phlegm, breathing problems such as emphysema or chronic bronchitis, or difficulty urinating due to prostate enlargement should seek medical advice before using this product.

While using this product, patients are cautioned not to exceed the recommended dosage, as it may cause marked drowsiness. The use of alcoholic drinks, sedatives, or tranquilizers may exacerbate drowsiness, and patients should exercise caution when driving or operating machinery. Excitability may occur, particularly in children.

Patients should discontinue use and consult a doctor if pain, cough, or nasal congestion worsens or persists beyond seven days, if fever worsens or lasts more than three days, if redness or swelling is present, if new symptoms arise, or if a cough recurs with a rash or headache that lasts. Additionally, if patients experience nervousness, dizziness, or sleeplessness, they should seek medical advice.

In the event of an overdose, it is critical for patients to seek immediate medical assistance or contact a Poison Control Center, as prompt medical attention is essential for both adults and children, even if no signs or symptoms are initially apparent.

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 for Parkinson's disease. It is advised to wait at least 2 weeks after discontinuing an MAOI before initiating this medication to avoid serious interactions.

Patients taking the anticoagulant warfarin should consult a healthcare professional prior to using this medication, as there may be an increased risk of bleeding.

Caution is advised when this medication is used in conjunction with alcohol, sedatives, or tranquilizers, as these substances may enhance drowsiness and impair cognitive and motor functions. Monitoring for increased sedation is recommended in such cases.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 12 years of age should not be administered this medication. It is contraindicated for use in children for sedation purposes. Caution is advised as excitability may occur, particularly in pediatric populations.

Healthcare professionals should ensure that this medication is kept out of reach of children. In the event of an overdose, immediate medical assistance should be sought, and contacting a Poison Control Center is recommended. Prompt medical attention is essential for both adults and children, even if no signs or symptoms are initially 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 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 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 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, which contains acetaminophen. Severe liver damage may occur if patients exceed the maximum daily dosage of 10 softgels within a 24-hour period. Additionally, patients should avoid concomitant use with other medications containing acetaminophen, as this may further increase the risk of liver injury.

Patients with compromised liver function are also advised to limit alcohol consumption to fewer than three alcoholic drinks per day while using this product, as alcohol can exacerbate the potential for liver damage.

It is recommended that patients with a history of liver disease consult a healthcare professional prior to using this product to ensure safe and appropriate use. Regular monitoring of liver function may be warranted in these patients to detect any potential adverse effects early.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Prompt medical intervention is crucial for both adults and children, even in the absence of observable signs or symptoms.

Healthcare professionals should be aware that the lack of immediate symptoms does not preclude the potential for serious health consequences. Therefore, it is essential to monitor the patient closely and provide appropriate care as needed.

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 shown that the following adverse reactions may occur: nervousness, dizziness, and sleeplessness. These events have been reported voluntarily or identified through surveillance programs.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. In the event of an overdose, it is crucial for patients 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 apparent.

Patients should be instructed not to exceed the recommended dosage to avoid potential adverse effects. It is important to inform patients that the medication may cause marked drowsiness, and they should be cautioned against consuming alcoholic drinks while taking it. Additionally, patients should be made aware that the combination of alcohol, sedatives, and tranquilizers can further increase drowsiness.

Healthcare providers should emphasize the need for caution when driving a motor vehicle or operating machinery due to the potential for impaired alertness. Lastly, patients should be informed that excitability may occur, particularly in children, and they should monitor for any unusual behavioral changes.

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 room temperature, maintaining a range of 15° to 30°C (59° to 86°F). Care should be taken to avoid exposure to excessive heat, as this may compromise the integrity of the product. Proper storage conditions are crucial to ensure the product remains effective and safe for use.

Additional Clinical Information

The medication is administered orally. For adults and children aged 12 years and older, the recommended dosage is 2 softgels taken with water every 4 hours, with a maximum of 10 softgels in a 24-hour period unless otherwise directed by a healthcare provider. The use of this medication is not recommended for children under 12 years of age.

Clinicians should counsel patients to consult a health professional if they are pregnant or breastfeeding. It is important to keep the medication out of reach of children. In the event of an overdose, immediate medical assistance should be sought, and contacting a Poison Control Center is advised, as prompt medical attention is crucial for both adults and children, even if no symptoms are apparent.

Drug Information (PDF)

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

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