Nightime

Description

The product identified by SPL code 34089-3 is designated as 694T-HEB-Nighttime-16s. This formulation is intended for nighttime use, although specific details regarding its active ingredients, dosage form, and molecular characteristics are not provided in the extracted data. Further information may be required to fully characterize the product's composition and intended therapeutic applications.

Uses and Indications

This drug is indicated for the temporary relief of symptoms associated with the common cold and influenza. Specifically, it alleviates cough due to minor throat and bronchial irritation, sore throat, headache, minor aches and pains, fever, as well as runny nose and sneezing.

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 4 doses 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

Use of this product is contraindicated in the following situations:

• Concurrent use 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.

• In patients currently taking a prescription monoamine oxidase inhibitor (MAOI) for depression, psychiatric or emotional conditions, or Parkinson's disease, or within 2 weeks of discontinuing such treatment. The interaction between this product and MAOIs may lead to serious adverse effects. If there is uncertainty about the presence of an MAOI in a prescription medication, a healthcare professional should be consulted prior to use.

Warnings and Precautions

This product contains acetaminophen, which poses a risk of severe liver damage if the following conditions are met: exceeding 4 doses within a 24-hour period, using other medications that also contain acetaminophen, or consuming 3 or more alcoholic drinks daily while using this product.

Allergy Alert Acetaminophen may lead to severe skin reactions. Symptoms indicative of such reactions include skin reddening, blisters, and rash. In the event of a skin reaction, it is imperative to discontinue use immediately and seek medical assistance.

Sore Throat Warning Healthcare professionals should advise patients to consult a doctor promptly if a sore throat is severe, persists for more than 2 days, or is accompanied or followed by fever, headache, rash, nausea, or vomiting.

General Precautions Patients should be instructed to consult a doctor prior to use if they have any of the following conditions: liver disease, glaucoma, a cough associated with excessive phlegm, breathing problems or chronic cough related to smoking, asthma, chronic bronchitis, or emphysema, or difficulty urinating due to an enlarged prostate gland. Additionally, patients should seek advice from a doctor or pharmacist before use if they are currently taking sedatives, tranquilizers, or the blood-thinning medication warfarin.

Emergency Medical Help In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center (1-800-222-1222) should be contacted. Prompt medical attention is crucial 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 a doctor if any of the following occur: pain or cough worsens or persists for more than 7 days; fever worsens or lasts more than 3 days; redness or swelling is observed; new symptoms develop; or if a cough recurs or is accompanied by a rash or headache that lasts. These symptoms may indicate a serious condition requiring further evaluation.

Side Effects

Severe liver damage may occur in patients taking this product containing acetaminophen if they exceed the maximum daily amount of 4 doses in 24 hours, use other medications containing acetaminophen concurrently, or consume 3 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. Additionally, if a sore throat is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, patients should consult a healthcare professional promptly.

While using this product, excitability may occur, particularly in children, and marked drowsiness is also a possibility. Patients are advised to avoid alcoholic beverages, as well as sedatives and tranquilizers, which may exacerbate drowsiness. Caution is recommended when driving a motor vehicle or operating machinery.

Patients should discontinue use and consult a doctor if pain or cough worsens or lasts longer than 7 days, if fever worsens or persists for more than 3 days, if redness or swelling is observed, if new symptoms arise, or if a cough recurs with a rash or headache that lasts. These symptoms could indicate a serious condition requiring medical evaluation.

Drug Interactions

Concurrent use of this medication with other products 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) for conditions such as depression, psychiatric disorders, or Parkinson's disease, as well as for a period of two weeks following the discontinuation of an MAOI. This interaction may lead to serious adverse effects, including hypertensive crises.

Patients should consult a healthcare professional prior to using this medication if they are concurrently taking sedatives or tranquilizers, as these substances may enhance the sedative effects of the medication, leading to increased drowsiness.

Additionally, caution is advised for patients taking warfarin or other anticoagulants. It is recommended that patients seek guidance from a healthcare provider before using this medication in conjunction with warfarin, as there may be an increased risk of bleeding.

The combined use of alcohol, sedatives, and tranquilizers with this medication may further amplify drowsiness and should be approached with caution. Monitoring for excessive sedation is advised in such cases.

Packaging & NDC

Below are the non-prescription pack sizes of Nightime (acetaminophen dextromethorphan hbr doxylamine succinate). 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 medication is contraindicated in children under 4 years of age.

Marked drowsiness may occur, particularly in pediatric patients, necessitating caution. Quick medical attention is essential for both adults and children, even in the absence of noticeable signs or symptoms.

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 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 individuals.

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 exercise caution when using this product, as it contains acetaminophen, which is associated with the risk of severe liver damage. It is critical that patients do not exceed 4 doses within a 24-hour period, as this represents the maximum daily amount for this product. Additionally, patients should avoid concomitant use with other medications containing acetaminophen, as this can further increase the risk of liver injury.

Patients with compromised liver function are advised to consult a healthcare professional prior to using this product, particularly if they have a history of liver disease. Furthermore, consumption of three or more alcoholic drinks daily while using this product is contraindicated, as it may exacerbate the risk of liver damage. Regular monitoring of liver function may be warranted in patients with existing liver conditions to ensure safety and efficacy during treatment.

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 intervention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Healthcare professionals should be aware that the timely administration of appropriate medical care can significantly influence the outcome of an overdose situation. Therefore, vigilance in monitoring for any potential symptoms is essential, as early recognition and management can mitigate the risks associated with overdose.

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

No specific postmarketing experience details are provided in the insert.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. In the event of an overdose, patients must seek medical help immediately 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 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 whether a drug contains acetaminophen, they should consult a doctor or pharmacist for clarification. Additionally, patients should be cautioned against using this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have stopped taking one within the last two weeks. If patients are unsure whether their prescription includes an MAOI, they should seek advice from a healthcare professional.

Patients should be instructed to discontinue use and consult a doctor if their pain or cough worsens or persists for more than seven days, if their fever worsens or lasts more than three days, or if they notice any redness or swelling. They should also seek medical advice if new symptoms arise or if a cough returns, particularly if accompanied by a rash or persistent headache, as these may indicate a serious condition.

When using this product, patients should be made aware that excitability may occur, especially in children, and that marked drowsiness is a possible side effect. They should be advised to avoid alcoholic beverages while using this medication, as alcohol, sedatives, and tranquilizers can enhance drowsiness. Caution should be exercised when driving or operating machinery.

Patients should be encouraged to consult a doctor before using this product if they have liver disease, glaucoma, a cough associated with excessive phlegm, or any breathing problems, including chronic coughs related to smoking, asthma, chronic bronchitis, or emphysema. Additionally, those experiencing difficulty urinating due to an enlarged prostate gland should seek medical advice prior to use. Finally, patients taking sedatives, tranquilizers, or the blood-thinning medication warfarin should also consult a doctor or pharmacist before using this product.

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 to maintain its integrity and effectiveness. Proper handling should be observed to ensure the product remains within the recommended storage conditions.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)