Daytime 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 alleviates nasal congestion, sinus congestion and pressure, minor aches and pains, headache, fever, sore throat, runny nose, sneezing, and cough due to minor throat and bronchial irritation. Additionally, it aids in promoting sleep by addressing cough and reduces swelling of the nasal passages, thereby facilitating nasal and/or sinus drainage and restoring freer breathing through the nose.

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 medication is to be taken only as directed, and healthcare professionals should refer to the Overdose warning for further information.

The provided dose cup must be utilized for accurate measurement. It is imperative that patients do not exceed a maximum of four doses within a 24-hour period.

For adults and children aged 12 years and older, the recommended dosage is 30 mL every 4 hours. For children aged 4 to under 12 years, it is advised to consult a physician for appropriate dosing recommendations. The medication is contraindicated for children under 4 years of age; therefore, it should not be used in this population.

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 there is uncertainty regarding the presence of acetaminophen in other medications, consultation with a healthcare professional is advised.

• Concurrent use with prescription monoamine oxidase inhibitors (MAOIs) or within 2 weeks of discontinuing an MAOI, as this may lead to serious drug interactions. Patients should verify with a healthcare provider if their current medications include an MAOI.

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

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen. Healthcare professionals should advise patients to avoid exceeding 4,000 mg of acetaminophen within a 24-hour period, to refrain from using other medications that also contain acetaminophen, and to limit alcohol consumption to fewer than three drinks per day while using this product.

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

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 advised to consult a physician promptly.

Healthcare professionals should recommend that patients consult a doctor prior to use if they have any of the following conditions: liver disease, heart disease, high blood pressure, thyroid disease, diabetes, glaucoma, a cough associated with excessive phlegm, breathing problems such as emphysema or chronic bronchitis, difficulty urinating due to an enlarged prostate gland, a persistent or chronic cough related to smoking, asthma, or emphysema, or if they are on a sodium-restricted diet.

Additionally, patients should be cautioned to seek advice from a doctor or pharmacist before using this product if they are currently taking sedatives, tranquilizers, or the blood-thinning medication warfarin.

In the event of an overdose, immediate medical attention is crucial. Patients should be instructed to contact a Poison Control Center at 1-800-222-1222 or seek emergency medical help right away, regardless of whether symptoms are present.

Patients should discontinue use and contact a healthcare provider if they experience nervousness, dizziness, or sleeplessness; if pain, nasal congestion, or cough worsens or persists beyond seven days; if fever worsens or lasts more than three days; if redness or swelling occurs; if new symptoms develop; or if a cough recurs or is accompanied by a rash or headache lasting longer than expected, as these may indicate a serious condition.

Side Effects

Severe liver damage may occur 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 potential for severe skin reactions associated with acetaminophen, 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.

Patients experiencing a severe sore throat that persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, should consult a healthcare professional promptly. Additionally, individuals should stop use and contact a doctor if they experience nervousness, dizziness, or sleeplessness; if pain, nasal congestion, or cough worsens or lasts longer than 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 or occurs with a rash or headache that persists, as these may indicate a serious condition.

While using this product, patients may experience excitability, particularly in children, as well as marked drowsiness. It is advised to avoid alcoholic beverages, as alcohol, sedatives, and tranquilizers may enhance drowsiness. Caution is recommended when driving a motor vehicle or operating machinery.

Patients with pre-existing conditions such as liver disease, heart disease, high blood pressure, thyroid disease, diabetes, glaucoma, or breathing problems (e.g., emphysema or chronic bronchitis) should consult a doctor before use. Additionally, those with trouble urinating due to an enlarged prostate gland, persistent or chronic cough (as seen in smoking, asthma, or emphysema), or those on a sodium-restricted diet should also seek medical advice prior to use.

Patients taking sedatives or tranquilizers, or the blood-thinning medication warfarin, should consult a doctor or pharmacist before using this product. In the event of an overdose, immediate medical attention is critical for both adults and children, even if no signs or symptoms are apparent. Patients are encouraged to contact a Poison Control Center at 1-800-222-1222 for assistance.

Drug Interactions

Acetaminophen has the potential to interact with warfarin, which may lead to an increased risk of bleeding. It is advisable to monitor the International Normalized Ratio (INR) closely in patients who are receiving both medications concurrently.

Monoamine oxidase inhibitors (MAOIs) are contraindicated in combination with products containing dextromethorphan due to the risk of severe hypertension. Caution should be exercised to avoid this combination to prevent adverse effects.

No additional drug interactions or drug and laboratory test interactions have been identified.

Packaging & NDC

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

Pediatric Use

Pediatric patients aged 4 to under 12 years should consult a healthcare professional before use. For children under 4 years, the product is contraindicated. The recommended dosage for adults and children aged 12 years and older is 30 mL every 4 hours. For children aged 6 to under 12 years, the dosage is 15 mL every 4 hours. Children aged 4 to under 6 years should also seek medical advice prior to use.

It is important to note that 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 particular safety concerns as indicated in the provided information. However, it is generally advisable for geriatric patients to consult a healthcare provider prior to use, particularly if they have underlying health conditions or are concurrently taking other medications. This precaution helps ensure safe and effective use of the medication in this population. Regular monitoring and assessment of the patient's overall health status are recommended to mitigate any potential risks associated with their 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 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 mothers.

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 impairment.

Hepatic Impairment

Patients with hepatic impairment should consult a healthcare professional prior to using this medication. It is essential for individuals with liver disease to receive appropriate guidance regarding the use of this product, as compromised liver function may affect the drug's metabolism and overall safety profile. Monitoring of liver function may be necessary to ensure the safe administration of the medication in this population.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222. 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 adverse effects. Therefore, vigilance and timely action are essential in managing overdose situations effectively.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to use.

Excitability may occur, particularly in children, and marked drowsiness has been observed.

No specific nonclinical toxicology data or animal pharmacology and toxicology data are provided in the insert.

Postmarketing Experience

Postmarketing experience has identified the potential for severe skin reactions associated with acetaminophen use. Reported symptoms of these reactions may include skin reddening, blisters, and rash. In the event of a skin reaction, it is advised to discontinue use and seek medical assistance immediately.

Additionally, users are encouraged to stop use and consult a healthcare professional if they experience any of the following: increased nervousness, dizziness, or sleeplessness; worsening pain, nasal congestion, or cough lasting more than 7 days; fever that worsens or persists beyond 3 days; presence of redness or swelling; emergence of new symptoms; or recurrence of cough accompanied by rash or headache lasting for an extended period. These symptoms may indicate a serious underlying condition.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 in the event of an overdose, emphasizing the importance of prompt medical attention for both adults and children, even if no signs or symptoms are apparent.

Patients should be instructed not to exceed the recommended dosage, as taking more than directed can lead to serious health risks. It is important to inform patients that excitability may occur, particularly in children, and that marked drowsiness is a possible side effect.

Providers should counsel patients to avoid consuming alcoholic beverages while using this medication, as alcohol can exacerbate drowsiness. Additionally, patients should be cautioned about the potential for increased drowsiness when combined with sedatives or tranquilizers.

Finally, healthcare providers should remind patients to exercise caution when driving or operating machinery, as the medication may impair their ability to perform these tasks safely.

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 controlled temperature range of 20-25°C (68-77°F) to maintain its integrity and efficacy. Proper storage conditions must be adhered to, ensuring that the product is kept within the specified temperature limits to prevent degradation.

Additional Clinical Information

Patients aged 12 years and older are advised to administer 30 mL every 4 hours, while those between 6 to under 12 years should take 15 mL every 4 hours. For children aged 4 to under 6 years, it is recommended to consult a doctor, and the product should not be used in children under 4 years of age.

Clinicians should counsel patients to seek advice from a health professional if they are pregnant or breastfeeding. It is essential to keep the product 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 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 Daytime Nighttime Severe Cold and Flu, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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