Asp Nighttime Max

Description

ASP Nighttime Max Capsules are provided in a bulk shipment containing 4000 capsules, identified by NDC No. 53345-053-01. It is imperative to inspect the product immediately upon receipt. These capsules are intended solely for further manufacturing, processing, or repacking. Proper storage conditions must be maintained; the product should be protected from heat, humidity, and light, and refrigeration is not recommended.

Uses and Indications

This drug is indicated for the temporary relief of symptoms associated with the common cold or influenza, including minor aches and pains, headache, nasal and sinus congestion, cough, sore throat, runny nose, and sneezing. Additionally, it is indicated for the temporary reduction of fever.

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

Dosage and Administration

Adults and children 12 years of age and over are instructed to take 2 softgels with water every 4 hours as needed. The total daily dosage must not exceed 10 softgels within a 24-hour period, unless otherwise directed by a healthcare professional.

For children under 12 years of age, the use of this medication is not recommended. It is imperative that patients adhere to the recommended dosing guidelines to avoid potential overdose.

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.

• Concurrent use with prescription monoamine oxidase inhibitors (MAOIs) or within 2 weeks of discontinuing an MAOI, as this may lead to serious drug interactions.

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

• In children under 12 years of age, due to safety concerns and lack of established efficacy in this population.

Warnings and Precautions

This product contains acetaminophen, which poses a risk of severe liver damage if the following conditions are met: exceeding 10 softgels within a 24-hour period, concurrent use with other medications containing acetaminophen, or consumption of three or more alcoholic drinks daily while using this product.

In addition, healthcare professionals should be aware of the sore throat warning. If a patient experiences a severe sore throat that persists for more than two days, or if it is accompanied or followed by fever, headache, rash, nausea, or vomiting, prompt consultation with a physician is advised. It is also important to note that this product should not be used to sedate children.

General precautions should be taken when considering this product for patients with specific health conditions. Patients should be advised to consult a healthcare provider prior to use if they have any of the following: liver disease, heart disease, high blood pressure, thyroid disease, diabetes, glaucoma, cough with excessive phlegm, a breathing problem such as emphysema or chronic bronchitis, difficulty urinating due to prostate gland enlargement, or a persistent or chronic cough associated with smoking, asthma, or emphysema. Additionally, patients should seek guidance from a doctor or pharmacist if they are currently taking blood thinners such as warfarin or sedatives and tranquilizers.

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

Patients should be instructed to discontinue use and contact their healthcare provider if any of the following occur: worsening pain, cough, or nasal congestion lasting more than seven days; fever worsening or lasting more than three days; presence of redness or swelling; emergence of new symptoms; recurrence of cough accompanied by a rash or headache; or if nervousness, dizziness, or sleeplessness develops. These symptoms may indicate a serious underlying condition that requires further evaluation.

Side Effects

Severe liver damage may occur in patients who exceed the maximum daily dosage of 10 softgels within 24 hours, take the product in conjunction with other drugs containing acetaminophen, or consume three or more alcoholic drinks daily while using this product. Patients should be advised to consult a doctor promptly if they experience a severe sore throat that persists for more than two days, or if it is accompanied or followed by fever, headache, rash, nausea, or vomiting.

This product is contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within two weeks of stopping such medication. Additionally, it should not be used in patients with a known allergy to this product or any of its ingredients, or in children under 12 years of age. Patients should also be cautious and seek medical advice before use if they have liver disease, heart disease, high blood pressure, thyroid disease, diabetes, glaucoma, a cough with excessive phlegm, a breathing problem such as emphysema or chronic bronchitis, or difficulty urinating due to prostate enlargement.

Patients taking blood thinners such as warfarin, or those on sedatives or tranquilizers, should consult a doctor or pharmacist prior to use. While using this product, patients are advised not to exceed the recommended dosage, as it may cause marked drowsiness. The consumption of alcoholic drinks, sedatives, and tranquilizers may further increase drowsiness, and patients should exercise caution when driving or operating machinery. Excitability may occur, particularly in children.

Patients should discontinue use and consult a doctor if pain, cough, or nasal congestion worsens or lasts more than seven days, if fever worsens or lasts more than three days, if redness or swelling is present, if new symptoms occur, or if a cough returns or occurs with a rash or headache that persists. Symptoms such as nervousness, dizziness, or sleeplessness should also prompt a consultation with a healthcare provider.

In the event of an overdose, it is critical for patients to seek medical help or contact a Poison Control Center immediately, as prompt medical attention is essential for both adults and children, even if no signs or symptoms are initially apparent.

Drug Interactions

Concurrent use of this medication with any other drug containing acetaminophen, whether prescription or nonprescription, is contraindicated due to the risk of acetaminophen overdose and potential hepatotoxicity.

The use of this medication is also contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications for depression, psychiatric conditions, or Parkinson's disease. Additionally, it should not be used for at least 2 weeks following the discontinuation of an MAOI.

Patients taking the anticoagulant warfarin should consult a healthcare professional prior to using this medication, as there may be an increased risk of bleeding.

Furthermore, caution is advised for individuals using sedatives or tranquilizers, as the combination may enhance sedative effects. The concurrent use of alcohol, sedatives, and tranquilizers can lead to increased drowsiness, necessitating careful monitoring of patients for excessive sedation or impairment.

Packaging & NDC

Below are the non-prescription pack sizes of Asp Nighttime Max (acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients should not be sedated with this medication. The use of this product is contraindicated in children under 12 years of age. Caution is advised when considering treatment options for pediatric populations.

Geriatric Use

There is no specific information 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. It is advisable to monitor these patients closely for any 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. 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.

Hepatic Impairment

Patients with hepatic impairment should exercise caution when using this product, which contains acetaminophen. Severe liver damage may occur if patients exceed the maximum daily dosage of 10 softgels within a 24-hour period. Additionally, patients should avoid concomitant use with other medications containing acetaminophen, as this may further increase the risk of liver injury.

Patients with compromised liver function are also advised to limit alcohol consumption to fewer than three alcoholic drinks per day while using this product, as alcohol can exacerbate the potential for liver damage.

It is recommended that patients with a history of liver disease consult a healthcare professional prior to using this product to ensure safe and appropriate use. Regular monitoring of liver function may be warranted in these patients to detect any potential adverse effects early.

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 adverse effects. Therefore, vigilance and timely action are essential in managing overdose situations effectively.

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 safety profile in nonclinical settings.

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions reported voluntarily or through surveillance programs: nervousness, dizziness, and sleeplessness. These events have been documented in the context of routine pharmacovigilance activities.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. In the event of an overdose, it is crucial for patients to seek medical help or contact a Poison Control Center immediately, as prompt medical attention is essential 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 the medication may cause marked drowsiness, and they should avoid consuming alcoholic drinks while taking it. Additionally, patients should be made aware that the combination of alcohol, sedatives, and tranquilizers can further increase drowsiness.

Healthcare providers should caution patients about the potential risks associated with driving a motor vehicle or operating machinery while under the influence of the medication. Lastly, it is important to inform patients that excitability may occur, particularly in children, and they should monitor for any unusual behavior.

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 room temperature, maintaining a range of 15° to 30°C (59° to 86°F). Care should be taken to avoid exposure to excessive heat to ensure the integrity of the product.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. It is crucial to keep the medication out of reach of children. In the event of an overdose, patients should seek medical assistance or contact a Poison Control Center immediately, as prompt medical attention is essential for both adults and children, even if no symptoms are apparent.

Drug Information (PDF)

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

View product document (PDF)