Nighttime Severe Cold and Flu

Description

No description information is available for the specified drug.

Uses and Indications

This drug is indicated for the temporary relief of symptoms associated with the common cold and influenza. Specifically, it addresses the following symptoms: nasal congestion, sinus congestion and pressure, cough due to minor throat and bronchial irritation, cough to facilitate sleep, minor aches and pains, headache, fever, sore throat, runny nose, and sneezing. Additionally, this drug reduces swelling of the nasal passages, temporarily restores freer breathing through the nose, and promotes nasal and/or sinus drainage.

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

Dosage and Administration

The medication should be taken only as directed. For adults and children aged 12 years and older, the recommended dosage is 2 Softgels taken with water every 6 hours, not to exceed 8 Softgels within a 24-hour period.

For children aged 4 to under 12 years, it is advised to consult a physician for appropriate dosing. The use of this medication is not recommended for children under 4 years of age.

Contraindications

There are no specific contraindications listed for this product. However, it is essential to keep the product out of reach of children to prevent accidental ingestion. In the event of an overdose, immediate medical assistance should be sought by contacting a Poison Control Center at 1-800-222-1222, as prompt intervention is critical for both adults and children, regardless of the presence of symptoms.

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 8 Softgels is exceeded within a 24-hour period. This risk is heightened when the product is taken in conjunction with other medications containing acetaminophen or when the patient consumes three or more alcoholic drinks daily while using this product. It is essential to monitor liver function in patients who may be at risk of exceeding these limits.

Allergy Alert Acetaminophen has the potential to cause severe skin reactions. Symptoms may include skin reddening, blisters, and rash. In the event of a skin reaction, patients should be advised to discontinue use immediately and seek medical assistance without delay.

Sore Throat Warning Healthcare professionals should instruct patients to consult a doctor if a sore throat is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting. Prompt medical evaluation is crucial in these cases to rule out serious underlying conditions.

Emergency Medical Help In the event of an overdose, it is imperative to seek emergency medical help or contact a Poison Control Center immediately at 1-800-222-1222. Quick medical attention is critical for both adults and children, even if no signs or symptoms are apparent.

Discontinuation of Use Patients should be advised to stop taking the product and contact their healthcare provider if any skin reactions occur. Immediate medical evaluation is necessary to address potential complications.

Side Effects

Severe liver damage may occur in patients who exceed the maximum daily dosage of 8 Softgels within a 24-hour period, particularly when used in conjunction with other medications containing acetaminophen or when consuming three or more alcoholic drinks daily while using this product.

Patients should be aware of the potential for severe skin reactions associated with acetaminophen. Symptoms of such reactions may include skin reddening, blisters, and rash. In the event of a skin reaction, it is imperative that patients discontinue use immediately and seek medical assistance.

Additionally, patients experiencing a sore throat should be vigilant. If the sore throat is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, it is advised that they consult a healthcare professional promptly.

Drug Interactions

There are currently no documented drug interactions associated with the use of this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

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

Pediatric Use

Pediatric patients aged 12 years and older may take 2 Softgels with water every 6 hours. For children aged 4 to under 12 years, it is advised to consult a doctor before use. The product is not recommended for children under 4 years of age.

It is essential to keep this medication out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center at 1-800-222-1222. Quick medical attention is critical 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 efficacy, given the lack of targeted data for this population.

Pregnancy

Safety during pregnancy has not been established for this product. It is contraindicated in pregnancy due to potential risks to the fetus associated with its use. Pregnant patients should avoid using this product unless directed by a healthcare professional. If a pregnant patient requires treatment, consultation with a healthcare provider is essential for any necessary dosage modifications.

Lactation

There are no specific warnings or recommendations regarding the use of this product in lactating mothers. Additionally, there is no information available concerning the potential for excretion in breast milk or any associated risks to breastfed infants.

Renal Impairment

There is no information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution and consider the lack of specific guidance when prescribing to patients with reduced kidney function.

Hepatic Impairment

Patients with hepatic impairment should exercise caution when using this product, which contains acetaminophen. It is important to note that severe liver damage may occur if patients exceed the maximum daily dosage of 8 Softgels within a 24-hour period. This limit applies not only to this product but also to any other medications containing acetaminophen. Additionally, patients who consume three or more alcoholic drinks daily while using this product are at an increased risk for liver damage.

Due to the potential for compromised liver function to affect the metabolism of acetaminophen, patients with hepatic impairment should be closely monitored for signs of liver toxicity. It is advisable for these patients to consult with a healthcare professional before using this product to ensure safe and appropriate use.

Overdosage

In the absence of specific overdosage information, it is essential for healthcare professionals to remain vigilant and consider general principles of management in cases of suspected overdose.

Healthcare providers should be aware that the clinical presentation of an overdose may vary significantly depending on the substance involved, the amount ingested, and the individual patient's characteristics. Symptoms of overdose can range from mild to severe and may include altered mental status, cardiovascular instability, respiratory distress, and gastrointestinal disturbances.

In the event of an overdose, immediate medical attention is warranted. The following steps are recommended for the management of suspected overdose cases:

1. Assessment: Conduct a thorough assessment of the patient's clinical status, including vital signs and level of consciousness.

2. Supportive Care: Initiate supportive care measures as necessary, which may include airway management, oxygen supplementation, and intravenous fluids.

3. Decontamination: If the overdose is recent and the patient is alert, consider activated charcoal administration to limit further absorption of the substance. Gastric lavage may be indicated in certain situations, but only if performed within a suitable timeframe and in a controlled setting.

4. Specific Antidotes: If applicable, administer specific antidotes as indicated for the substance involved in the overdose.

5. Monitoring: Continuous monitoring of the patient is crucial to detect any deterioration in their condition and to guide further management.

6. Consultation: Engage with a poison control center or toxicology expert for additional guidance tailored to the specific circumstances of the overdose.

In summary, while no specific overdosage information is provided, healthcare professionals should be prepared to implement general overdose management protocols and remain alert to the potential for serious complications.

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 the following adverse reactions: severe skin reactions, which may manifest as skin reddening, blisters, and rash. In the event of a skin reaction, it is advised that the use of the product be discontinued immediately and medical assistance be sought.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. It is essential to emphasize the importance of seeking immediate medical assistance in the event of an overdose. Patients should be informed to contact a Poison Control Center at 1-800-222-1222 or seek medical help right away, regardless of whether they observe any signs or symptoms. Quick medical attention is critical for both adults and children in such situations.

Storage and Handling

The product is supplied in a container that must be kept tightly closed to maintain integrity. It should be stored at a temperature range of 20°C to 25°C (68°F to 77°F), with permissible excursions between 15°C to 30°C (59°F to 86°F). It is essential to protect the product from light to prevent degradation. Additionally, the product should be discarded after opening to ensure safety and efficacy.

Additional Clinical Information

Patients should be informed that the medication is administered orally. It is crucial to keep the medication out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center at 1-800-222-1222, as prompt attention is essential for both adults and children, even if no symptoms are apparent.

Clinicians should advise patients about the potential for severe skin reactions associated with acetaminophen, which may manifest as skin reddening, blisters, or rash. If any of these symptoms occur, patients should discontinue use and seek medical help immediately. Additionally, patients should be cautioned to consult a doctor if a sore throat is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting.

Drug Information (PDF)

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

View product document (PDF)