Nighttime Ultra Concentrated Cold and Flu

Description

No relevant information is available for SPL code 34089-3.

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 4 hours, not to exceed 8 softgels within a 24-hour period.

For children aged 4 to under 12 years, it is advised to consult a physician for appropriate dosing recommendations. 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) or within 2 weeks of discontinuing such treatment. MAOIs are commonly prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. 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

Severe liver damage may occur with the use of this product, which contains acetaminophen. Healthcare professionals should advise patients to adhere strictly to the recommended dosage, which is a maximum of 8 softgels in a 24-hour period. Caution is particularly warranted if patients are concurrently using other medications that contain acetaminophen or if they consume three or more alcoholic drinks daily while using this product.

Acetaminophen has been associated with severe skin reactions. Symptoms indicative of such reactions may include skin reddening, blisters, and rash. Should any of these symptoms manifest, patients must discontinue use immediately and seek medical assistance.

In cases of severe sore throat that persists for more than two days, or if it is accompanied or followed by fever, headache, rash, nausea, or vomiting, patients should be advised to consult a physician without delay.

Patients should be instructed to stop use and seek medical advice if any of the following occur:

• Pain or cough worsens or lasts longer than 7 days.

• Fever worsens or persists for more than 3 days.

• Redness or swelling is observed.

• New symptoms develop.

• Cough recurs or is accompanied by a rash or headache that lasts.

In the event of an overdose, immediate medical attention is essential. Patients should be directed to contact a Poison Control Center at 1-800-222-1222 or seek emergency medical help right away, as prompt intervention is critical for both adults and children, even in the absence of noticeable signs or symptoms.

Side Effects

Patients using this product should be aware of several important warnings and potential adverse reactions.

Severe liver damage may occur with the use of this product, particularly if patients exceed the maximum daily dosage of 8 softgels within a 24-hour period, use other medications containing acetaminophen concurrently, or consume three or more alcoholic drinks daily while using this product.

Additionally, there is an allergy alert associated with acetaminophen, which may lead to severe skin reactions. Symptoms of such reactions can include skin reddening, blisters, and rash. Patients experiencing any of these symptoms should discontinue use immediately and seek medical assistance.

Patients should also be cautious regarding sore throat symptoms. If a sore throat is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, it is advised to consult a healthcare professional promptly.

Furthermore, patients are advised to stop use and consult a doctor if any of the following occur: pain or cough worsens or lasts longer than seven days; fever worsens or lasts longer than three days; redness or swelling is present; new symptoms develop; or if a cough returns or occurs with a rash or headache that persists. These symptoms may 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.

The use of this medication is also contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) for conditions such as depression, psychiatric or emotional disorders, or Parkinson's disease, as well as for a period of two weeks following the discontinuation of an MAOI.

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.

Additionally, individuals taking the anticoagulant warfarin should seek advice from a healthcare provider before using this medication, as potential interactions may affect anticoagulation control.

It is important to note that the concomitant use of alcohol, sedatives, and tranquilizers may lead to increased drowsiness, necessitating caution in activities requiring alertness.

Packaging & NDC

Below are the non-prescription pack sizes of Nighttime Ultra Concentrated Cold and Flu (acetaminophen, dextromethorphan hbr, doxylamine succinate softgels). 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 adolescents and adults aged 12 years and older, the recommended dosage is 2 softgels with water every 4 hours, with a maximum of 8 softgels in a 24-hour period.

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 require specific dosage adjustments when receiving this medication, as there are no safety concerns or dosage modifications indicated in the available data. However, healthcare providers should remain vigilant in monitoring this population for any potential adverse effects, given the general considerations associated with pharmacotherapy in geriatric patients. It is advisable to assess the overall health status and comorbidities of elderly patients to ensure optimal therapeutic outcomes.

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 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 may not have specific information regarding dosage adjustments, special monitoring, or safety considerations outlined in the prescribing information. Therefore, healthcare professionals should exercise caution when prescribing to this population, as the absence of detailed guidance necessitates careful clinical judgment and individualized patient assessment.

Hepatic Impairment

Patients with hepatic impairment should be closely monitored when using this product, which contains acetaminophen. It is important to note that severe liver damage may occur if patients exceed the maximum daily dosage of 8 softgels within a 24-hour period. Additionally, patients should avoid concomitant use of other medications containing acetaminophen, as this can further increase the risk of liver injury.

Patients with compromised liver function are also advised to limit alcohol consumption to fewer than 3 alcoholic drinks per day while using this product. Due to the potential for increased susceptibility to liver damage, careful consideration of the patient's overall liver health and function is essential when determining the appropriateness of this product for use. Regular monitoring of liver function tests may be warranted in patients with significant hepatic impairment to ensure safety and efficacy.

Overdosage

In cases of overdosage, it is critical to recognize the potential for severe liver damage associated with the use of this product.

Maximum Daily Dosage Healthcare professionals should advise patients that exceeding the maximum recommended dosage of 8 softgels within a 24-hour period significantly increases the risk of severe liver damage.

Drug Interactions The concomitant use of this product with other medications containing acetaminophen can also lead to severe liver damage. It is essential for healthcare providers to review a patient's medication history thoroughly to prevent such interactions.

Alcohol Consumption Patients should be cautioned against the consumption of three or more alcoholic drinks daily while using this product, as this behavior further elevates the risk of liver damage.

In the event of suspected overdosage, immediate medical attention is warranted. Healthcare professionals should monitor liver function and consider appropriate management strategies based on the severity of the symptoms presented.

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 use of the compound in these contexts.

Postmarketing Experience

Postmarketing experience has identified that acetaminophen may be associated with severe skin reactions. Reports indicate that symptoms can include skin reddening, blisters, and rash. In the event of a skin reaction, it is advised to discontinue use immediately and seek medical assistance.

Patient Counseling

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

Patients should be informed not to use this product in conjunction with any other medication containing acetaminophen, whether prescription or nonprescription. If patients are uncertain whether a drug contains acetaminophen, 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) for conditions such as depression, psychiatric or emotional disorders, or Parkinson's disease, or for two weeks after discontinuing an MAOI. Patients should be encouraged to ask their healthcare provider if they are unsure whether their prescription includes an MAOI.

Patients should be advised to stop using the product 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, if they notice any redness or swelling, or if new symptoms develop. Additionally, they should seek medical advice if a cough returns or occurs alongside a rash or headache that lasts, as these may indicate a serious condition.

When using this product, patients should adhere strictly to the recommended dosage and be aware that excitability may occur, particularly in children. Marked drowsiness is also a potential side effect, and patients should be cautioned against consuming alcoholic beverages while using this product. They should exercise caution when driving or operating machinery, as alcohol, sedatives, and tranquilizers may enhance drowsiness.

Patients should be encouraged to consult a doctor before using this product if they have liver disease, glaucoma, a cough accompanied by excessive phlegm, a chronic cough related to smoking, asthma, chronic bronchitis, or emphysema. They should also seek medical advice if they experience difficulty urinating due to an enlarged prostate gland. Furthermore, patients should consult a doctor or pharmacist if they are taking sedatives, tranquilizers, or the blood-thinning medication warfarin.

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 not exceeding 25°C to maintain its integrity and efficacy. Proper storage conditions should be observed to ensure optimal performance.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

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