Nite Time Severe Cold and Flu

Description

NDC 41250-877-08. This product, marketed under the Meijer® brand, is a maximum strength nighttime formulation for the relief of severe cold and flu symptoms, including congestion. Each caplet contains acetaminophen, a pain reliever and fever reducer; dextromethorphan HBr, a cough suppressant; doxylamine succinate, an antihistamine; and phenylephrine HCl, a nasal decongestant. The product is presented in a package containing 24 caplets. It is tamper evident; do not use if the package is opened or if the blister unit is torn, broken, or shows any signs of tampering. Distributed by Meijer Distribution, Inc., Grand Rapids, MI 49544. For more information, visit www.meijer.com.

Uses and Indications

This drug is indicated for the temporary relief of symptoms associated with the common cold and influenza. Specifically, it alleviates minor aches and pains, sinus congestion and pressure, sore throat, fever, headache, nasal congestion, and cough. Additionally, it aids in promoting nasal and/or sinus drainage, temporarily restores freer breathing through the nose, and reduces swelling of the nasal passages.

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

Dosage and Administration

Patients should adhere strictly to the recommended dosage and not exceed the maximum daily limit. For adults and children aged 12 years and older, the recommended dosage is 2 caplets taken with water every 4 hours, with a maximum of 8 caplets within a 24-hour period.

For children under 12 years of age, it is advised to consult a physician for appropriate dosing recommendations.

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) or within 2 weeks of discontinuing such treatment. MAOIs are commonly prescribed for depression, psychiatric or emotional conditions, or Parkinson’s disease. If there is uncertainty about the presence of an MAOI in a prescription, a healthcare professional should be consulted prior to use.

• In individuals with a history of allergic reactions to this product or any of its ingredients, as this may lead to severe allergic responses.

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 this product in conjunction with other medications containing acetaminophen, or consumes three or more alcoholic drinks daily while using this product. It is imperative 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 blisters, rash, or skin reddening. Should any of these symptoms arise, patients must be advised 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 instructed to consult a physician without delay.

General Precautions Healthcare professionals should advise patients to consult a doctor prior to use if they have any of the following conditions: liver disease, diabetes, thyroid disease, heart disease, glaucoma, difficulty urinating due to prostate enlargement, high blood pressure, or chronic respiratory issues such as asthma, chronic bronchitis, or emphysema. 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 crucial. Patients should be instructed to contact a Poison Control Center or seek emergency medical help, regardless of whether symptoms are present.

Discontinuation of Use Patients should be advised to stop taking this product and consult a healthcare provider if they experience nervousness, dizziness, or sleeplessness; if pain, nasal congestion, or cough worsens or persists beyond seven days; if new symptoms develop; if fever worsens or lasts more than three days; if redness or swelling occurs; or if a cough recurs with a rash or headache lasting longer than usual. 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 4,000 mg of acetaminophen 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 blisters, rash, or skin reddening. 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 nervousness, dizziness, or sleeplessness. Patients should discontinue use and consult a doctor if pain, nasal congestion, or cough worsens or lasts longer than seven days, if new symptoms arise, if fever worsens or persists beyond three days, or if redness or swelling is observed. A return of cough or the occurrence of cough with rash or headache that lasts may indicate a serious condition requiring medical evaluation.

While using this product, patients may experience excitability, particularly in children, and marked drowsiness. The use of alcohol, sedatives, and tranquilizers may exacerbate drowsiness, and patients are advised to avoid alcoholic beverages. Caution is recommended when driving a motor vehicle or operating machinery.

It is crucial for patients to adhere to the recommended dosage to mitigate the risk of adverse reactions.

Drug Interactions

Concurrent use of this medication with other products containing acetaminophen, whether prescription or nonprescription, is contraindicated due to the risk of acetaminophen overdose.

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, as well as for a period of two weeks following the discontinuation of an MAOI.

Patients should consult a healthcare professional prior to using this medication if they are concurrently taking sedatives or tranquilizers, as these substances may enhance drowsiness. Additionally, individuals on the anticoagulant warfarin should seek advice from a healthcare provider before use, as potential interactions may necessitate monitoring or dosage adjustments.

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

Packaging & NDC

Below are the non-prescription pack sizes of Nite Time Severe Cold and Flu (acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional before use. For adolescents aged 12 years and older, the recommended dosage is 2 caplets taken with water every 4 hours.

Caution is advised as excitability may occur, particularly in children. Additionally, marked drowsiness is a potential side effect that should be monitored. It is essential to keep this medication out of reach of children to prevent accidental ingestion.

In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center without delay. Prompt medical attention is critical for both adults and children, even if no signs or symptoms are apparent.

Geriatric Use

There is no specific information available 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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in 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 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 no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data 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 4,000 mg of acetaminophen within a 24-hour period. Additionally, patients should avoid the concurrent use of other medications containing acetaminophen and limit alcohol consumption to fewer than three alcoholic drinks per day while using this product.

Before initiating treatment, patients with known liver disease are advised to consult a healthcare professional. Monitoring of liver function may be warranted in these patients to ensure safety and efficacy during the course of therapy.

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 noticeable 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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

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

Additionally, users are instructed to stop use and consult a healthcare professional if they experience nervousness, dizziness, or sleeplessness. Other concerning symptoms include worsening pain, nasal congestion, or cough lasting more than 7 days, as well as fever that worsens or persists beyond 3 days. The presence of redness or swelling, the emergence of new symptoms, or a cough that recurs or is accompanied by a rash or headache lasting an extended period may indicate a serious condition requiring medical evaluation.

In cases of overdose, it is crucial to seek medical help or contact a Poison Control Center without delay, as prompt medical attention is essential for both adults and children, even in the absence of noticeable signs or symptoms.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center in the event of an overdose, emphasizing that prompt medical attention is crucial 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 excitability may occur, particularly in children, and that marked drowsiness is a possible side effect.

Healthcare providers should caution patients about the increased risk of drowsiness when consuming alcohol, sedatives, or tranquilizers, and strongly recommend avoiding alcoholic beverages while taking this medication. Additionally, patients should be made aware of the need for caution when driving a motor vehicle or operating machinery due to the potential for drowsiness.

Storage and Handling

The product is supplied in a tamper-evident package. It should not be used if the outer package is opened or if the blister is torn or broken. The recommended storage temperature is 25°C (77°F), with permissible excursions between 15°C and 30°C (59°F to 86°F). For tracking purposes, the expiration date and lot number can be found on the end flap of the packaging.

Additional Clinical Information

Patients should be informed that the medication is administered orally. Clinicians are advised to counsel patients on important safety measures, including the necessity of consulting a health professional if pregnant or breastfeeding. It is crucial 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 recommended, as prompt attention is vital for both adults and children, regardless of the presence of symptoms.

Additionally, clinicians may refer to resources such as www.StopMedicineAbuse.org to understand issues related to medicine abuse among teenagers. No further information is available regarding laboratory tests or postmarketing experiences.

Drug Information (PDF)

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

View product document (PDF)