Nitetime Severe

Description

Nitetime Severe is a combination medication formulated to provide nighttime relief from cold and flu symptoms. It contains the following active ingredients: acetaminophen, dextromethorphan HBr, doxylamine succinate, and phenylephrine HCl. Acetaminophen serves as a pain reliever and fever reducer, while dextromethorphan HBr acts as a cough suppressant. Doxylamine succinate functions as an antihistamine, and phenylephrine HCl is included as a nasal decongestant. This product is available in a maximum strength dosage form and is presented in a berry flavor. Each bottle contains 12 fluid ounces (355 mL) of the solution.

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 total of 4 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. The medication is contraindicated for children under 4 years of age; therefore, it should not be used in this age group.

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. This includes certain medications prescribed for depression, psychiatric or emotional conditions, or Parkinson’s disease, as the combination may lead to serious adverse effects. Verification of MAOI status with a healthcare provider is recommended if there is any doubt.

• History of allergic reaction to this product or any of its components, as this may result in severe allergic responses.

Warnings and Precautions

This product contains acetaminophen, which carries significant risks for liver damage. Healthcare professionals should advise patients that severe liver damage may occur if they 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 alerted to the potential for severe skin reactions associated with acetaminophen. Symptoms may include skin reddening, blisters, and rash. In the event of a skin reaction, patients must 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 instructed to consult a physician promptly.

Healthcare providers 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 that produces excessive phlegm, a breathing problem such as emphysema or chronic bronchitis, difficulty urinating due to an enlarged prostate gland, a persistent or chronic cough (e.g., due to smoking, asthma, or emphysema), or if they are on a sodium-restricted diet.

Additionally, patients should be advised to seek guidance 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 (1-800-222-1222) or seek emergency medical help right away, regardless of whether they exhibit signs or symptoms.

Patients must be advised to discontinue use and contact their 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 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 skin reddening, blisters, or rash. If any of these symptoms occur, 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 should consult a healthcare provider promptly.

Common adverse reactions may include nervousness, dizziness, or sleeplessness. Patients are advised to stop use and consult a doctor if pain, nasal congestion, or cough worsens or lasts longer than seven days, if fever worsens or persists beyond three days, if redness or swelling is observed, or if new symptoms arise. A return of cough or the occurrence of cough with rash or headache that lasts may indicate a serious condition requiring medical evaluation.

Patients with pre-existing conditions such as liver disease, heart disease, high blood pressure, thyroid disease, diabetes, glaucoma, or chronic respiratory issues should seek medical advice before using this product. Additionally, those experiencing persistent coughs, particularly those associated with smoking, asthma, or emphysema, or those on a sodium-restricted diet should consult a healthcare professional prior to use.

Caution is advised when using this product in conjunction with sedatives, tranquilizers, or the blood-thinning medication warfarin, as these may interact adversely. During use, patients should adhere strictly to dosing instructions to avoid excitability, particularly in children, and be aware that marked drowsiness may occur. Alcoholic beverages, sedatives, and tranquilizers can exacerbate drowsiness, necessitating caution when driving or operating machinery.

In the event of an overdose, immediate medical attention is crucial. Patients should contact a Poison Control Center or seek emergency medical help without delay, as prompt intervention is essential for both adults and children, even in the absence of noticeable symptoms.

Drug Interactions

Co-administration of this medication with any other product containing acetaminophen, whether prescription or nonprescription, is contraindicated. Patients should be advised to consult a healthcare professional if there is uncertainty regarding the presence of acetaminophen in other medications.

Caution is advised when considering the use of this medication in conjunction with prescription monoamine oxidase inhibitors (MAOIs), which are utilized for the treatment of depression, psychiatric disorders, or Parkinson’s disease. Patients should seek guidance from a healthcare provider if they are currently taking an MAOI or have discontinued such treatment within the past two weeks.

The concomitant use of this medication with warfarin, an anticoagulant, may elevate the risk of bleeding. Monitoring of coagulation parameters is recommended to ensure patient safety.

Additionally, the use of alcohol, sedatives, and tranquilizers in conjunction with this medication may potentiate drowsiness. Patients should be advised to exercise caution and consider avoiding these substances to mitigate the risk of excessive sedation.

Packaging & NDC

Below are the non-prescription pack sizes of Nitetime Severe (acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride). 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. The product is not recommended for children under 4 years of age. For dosing, adults and children aged 12 years and older may take 30 mL every 4 hours. Caution is advised as excitability may occur, particularly in children. 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 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. It is important to assess the potential risks and benefits, as well as any available data regarding fetal outcomes and lactation. Healthcare providers can offer guidance tailored to individual circumstances, ensuring the safety of both the patient and the developing fetus or nursing 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 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.

Hepatic Impairment

Patients with hepatic impairment should consult a healthcare professional prior to using this product. The presence of liver disease may necessitate caution due to the potential for increased risk of adverse effects.

This product contains acetaminophen, which is associated with the risk of severe liver damage. Patients with compromised liver function should be particularly vigilant regarding the maximum dosage of acetaminophen. It is critical that patients do not exceed 4,000 mg of acetaminophen within a 24-hour period. Additionally, concurrent use of other medications containing acetaminophen or the consumption of three or more alcoholic drinks daily while using this product may further elevate the risk of liver damage.

Monitoring of liver function may be warranted in patients with hepatic impairment to ensure safety and efficacy while using this product.

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 severity of symptoms may vary based on the specific substance involved in the overdose. Therefore, a thorough assessment and monitoring of the patient are essential.

Management of an overdose may include supportive care and symptomatic treatment, tailored to the individual’s clinical presentation. Continuous evaluation and appropriate interventions should be initiated as necessary to mitigate potential complications.

Nonclinical Toxicology

If pregnant or breast-feeding, it is advised to consult a health professional before use due to potential teratogenic effects.

Excitability may occur, particularly in children, alongside marked drowsiness. The concomitant use of alcohol, sedatives, and tranquilizers may enhance drowsiness.

No specific information is available regarding nonclinical toxicology or animal pharmacology and toxicology in the insert.

Postmarketing Experience

Postmarketing experience has identified several important safety considerations associated with the use of acetaminophen. Reports indicate that severe skin reactions may occur, characterized by symptoms such as skin reddening, blisters, and rash. In the event of a skin reaction, it is advised to discontinue use and seek medical assistance immediately.

Additionally, excitability has been noted, particularly in pediatric populations. Marked drowsiness is another reported effect, which may be exacerbated by the concurrent use of alcohol, sedatives, or tranquilizers.

Healthcare professionals are advised to instruct patients to discontinue use and consult a physician if symptoms such as pain, nasal congestion, or cough worsen or persist beyond 7 days, if fever worsens or lasts more than 3 days, or if any redness or swelling occurs. The emergence of new symptoms, or a cough that recurs or is accompanied by a rash or persistent headache, may indicate a serious underlying condition requiring medical evaluation.

Patient Counseling

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

Patients should be informed not to use this product in conjunction with any other medications containing acetaminophen, whether prescription or nonprescription. If patients are uncertain about the presence of acetaminophen in their medications, they should consult a doctor or pharmacist.

It is important to instruct patients not to use this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have stopped taking an MAOI within the past two weeks. Patients should be encouraged to ask their healthcare provider or pharmacist if they are unsure whether their prescription includes an MAOI.

Patients with a history of allergic reactions to this product or any of its ingredients should be advised against its use. Healthcare providers should counsel patients to discontinue use and consult a doctor if they experience nervousness, dizziness, or sleeplessness.

Patients should also be informed to stop using the product and seek medical advice if pain, nasal congestion, 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. New symptoms that arise should prompt a consultation with a healthcare provider, as should a cough that returns or occurs alongside a rash or headache lasting longer than usual, as these may indicate a serious condition.

When using this product, patients should be cautioned not to exceed 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 while using this product, as well as to exercise caution when driving or operating machinery. The use of alcohol, sedatives, and tranquilizers may enhance drowsiness.

Healthcare providers should recommend that patients consult a doctor before using this product 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, or a persistent or chronic cough related to smoking, asthma, or emphysema. Additionally, patients on a sodium-restricted diet or those taking sedatives, tranquilizers, or the blood-thinning medication warfarin should also seek advice 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 is essential to store the product at a temperature range of 68-77°F (20-25°C) to maintain its integrity and efficacy. Proper storage conditions must be adhered to, ensuring that the product is kept within the specified temperature range at all times.

Additional Clinical Information

The medication is administered orally. Clinicians should counsel patients to exercise caution when driving or operating machinery, as the medication may cause drowsiness, especially when combined with alcohol, sedatives, or tranquilizers. Patients should be advised to monitor for worsening symptoms, such as increased pain, nasal congestion, or cough lasting more than 7 days, fever persisting beyond 3 days, or the presence of redness or swelling. New symptoms or a recurrence of cough accompanied by a rash or headache warrant immediate medical attention, as these may indicate a serious condition.

Patients should adhere strictly to the dosing instructions, using only the provided dose cup and not exceeding 4 doses within a 24-hour period. It is important to take the medication only as directed to avoid the risk of overdose.

Drug Information (PDF)

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

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