Nitetime Daytime

Description

Acetaminophen is included as a pain reliever and fever reducer. Dextromethorphan HBr serves as a cough suppressant, while guaifenesin functions as an expectorant. Phenylephrine HCl acts as a nasal decongestant. The formulation is free from alcohol and antihistamines, incorporating doxylamine succinate as an antihistamine component. The product is available in a mixed berry flavor and is sugar-free. It provides multi-symptom relief and is packaged in 2 to 12 FL OZ (355 mL) bottles, with a total volume of 24 FL OZ (1.5 pt) (710 mL).

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 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 to ensure safety and efficacy. The recommended dosage for adults and children aged 12 years and older is 30 mL administered orally every 4 hours. It is imperative that patients do not exceed 4 doses within a 24-hour period.

For children aged 4 to under 12 years, it is advised to consult a healthcare professional for appropriate dosing recommendations. The use of this medication is contraindicated in children under 4 years of age.

Patients must utilize only the dose cup provided with the medication to ensure accurate dosing. Care should be taken to avoid overdose, and any concerns regarding dosage should be directed to a healthcare provider.

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), which are used for the treatment of depression, psychiatric or emotional conditions, or Parkinson’s disease, as well as for a period of 2 weeks following the discontinuation of an MAOI. Patients should verify with a healthcare professional if their prescription medications contain an MAOI.

• History of allergic reactions to this product or any of its ingredients, as this may lead to 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 lead to severe skin reactions. Symptoms such as skin reddening, blisters, or rash may indicate an allergic reaction. In the event of a skin reaction, 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 if accompanied by fever, headache, rash, nausea, or vomiting, patients should be advised to consult a physician promptly.

General precautions should be taken for patients with specific health conditions. Prior to use, patients should be encouraged to consult a healthcare provider if they have liver disease, heart disease, high blood pressure, thyroid disease, diabetes, glaucoma, a cough associated with excessive phlegm, a breathing problem such as emphysema or chronic bronchitis, difficulty urinating due to an enlarged prostate gland, a persistent cough related to smoking, asthma, or emphysema, or if they are on a sodium-restricted diet. Additionally, patients should seek advice from a doctor or pharmacist if they are 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 signs or symptoms are present.

Patients should 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 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.

If a patient experiences a severe sore throat that persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, they should consult a healthcare provider promptly.

Patients are advised to 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, excitability may occur, particularly in children, and marked drowsiness is also a possibility. Patients are cautioned to avoid alcoholic beverages, as well as to exercise caution when driving or operating machinery, given that alcohol, sedatives, and tranquilizers may enhance drowsiness.

Patients with liver disease, heart disease, high blood pressure, thyroid disease, diabetes, glaucoma, or breathing problems such as emphysema or chronic bronchitis should consult a doctor before use. Additionally, those experiencing trouble urinating due to an enlarged prostate gland, persistent or chronic cough (such as that associated with 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, it is critical to seek medical help or contact a Poison Control Center immediately at 1-800-222-1222. Prompt medical attention is essential for both adults and children, even if no signs or symptoms are immediately apparent.

Drug Interactions

Concurrent use of this product with other medications containing acetaminophen, whether prescription or nonprescription, is contraindicated. Patients should consult a healthcare professional if there is uncertainty regarding the presence of acetaminophen in any medication.

The use of this product is also contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within two weeks of discontinuing such treatment. MAOIs are commonly prescribed for depression, psychiatric conditions, or Parkinson’s disease. Patients should verify with a healthcare provider or pharmacist if their current medications include an MAOI.

Caution is advised when this product is used in conjunction with warfarin, as it may elevate the risk of bleeding. Monitoring of coagulation parameters is recommended to ensure patient safety.

Additionally, the concomitant use of alcohol, sedatives, and tranquilizers may enhance drowsiness associated with this product. Patients should be advised to exercise caution and consider dosage adjustments or monitoring for sedation effects when combining these substances.

Packaging & NDC

Below are the non-prescription pack sizes of Nitetime Daytime (acetaminophen, dextromethorphan hbr, doxylamine succinate, 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 children aged 6 to under 12 years is 15 mL every 4 hours, while adults and children aged 12 years and over may take 30 mL every 4 hours.

Caution is advised as excitability may occur, particularly in children. Additionally, marked drowsiness is a potential side effect. In the event of an overdose, it is crucial to seek immediate medical attention for both adults and children, even if no signs or symptoms are apparent.

Geriatric Use

Elderly patients, defined as those aged 65 years and older, do not have specific recommendations or dosage adjustments outlined in the prescribing information. Additionally, the insert does not explicitly mention any special precautions or safety concerns that are unique to this population.

Healthcare providers should exercise clinical judgment when prescribing this medication to geriatric patients, considering the potential for altered pharmacokinetics and pharmacodynamics in this age group. Regular monitoring and assessment of therapeutic outcomes and adverse effects are advisable to ensure the safety and efficacy of treatment in elderly patients.

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 on the excretion of this drug 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 should consult a healthcare professional prior to use, particularly if they experience difficulty urinating 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 be advised of the potential risks associated with the use of this product, particularly due to its acetaminophen content. Severe liver damage may occur if patients exceed a dosage of 4,000 mg of acetaminophen within a 24-hour period, especially when combined with other medications containing acetaminophen or when consuming three or more alcoholic drinks daily while using this product.

It is recommended that patients with known liver disease consult a healthcare professional prior to using this product. Monitoring of liver function may be warranted in these patients to ensure safety and to mitigate the risk of hepatotoxicity.

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, and early recognition and management are essential to mitigate potential complications. It is recommended that healthcare providers remain vigilant and prepared to initiate appropriate treatment protocols based on the specific circumstances of the overdose.

Nonclinical Toxicology

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

Excitability has been observed, particularly in pediatric populations. Additionally, marked drowsiness may occur as a potential effect.

No specific information regarding nonclinical toxicology or animal pharmacology and toxicology is available 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 immediately and seek medical assistance.

Additionally, there is a warning regarding the risk of overdose. In cases of suspected overdose, it is crucial to obtain medical help or contact a Poison Control Center promptly at 1-800-222-1222. Timely medical intervention 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 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 upon request. 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 in a suitable container that protects it from environmental factors. Special handling requirements should be followed to prevent any compromise to the product's quality.

Additional Clinical Information

Patients aged 12 years and older are advised to administer 30 mL every 4 hours, while children aged 6 to under 12 years should receive 15 mL every 4 hours. For children aged 4 to under 6 years, consultation with a doctor is recommended, and the product should not be used in children under 4 years of age. It is crucial for patients to adhere strictly to the dosing instructions, utilizing only the provided dose cup and not exceeding 4 doses within a 24-hour period.

Clinicians should counsel patients to avoid alcoholic beverages and to exercise caution when driving or operating machinery, as alcohol, sedatives, and tranquilizers may enhance drowsiness. Patients should be advised to seek medical attention if they experience worsening symptoms such as persistent pain, nasal congestion, or cough lasting more than 7 days, fever lasting more than 3 days, or the emergence of new symptoms. Additionally, they should be alert for signs of serious conditions, such as a cough that returns or occurs with a rash or headache that persists.

Drug Information (PDF)

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

View product document (PDF)