Nighttime Cold and Flu Max Softgels

Description

No description information is available for the specified drug.

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 effects associated with this drug, and no nonteratogenic effects have been reported.

Dosage and Administration

The medication should be taken only as directed, with a maximum dosage of 8 softgels within a 24-hour period. For adults and children aged 12 years and older, the recommended dosage is 2 softgels taken with water every 6 hours as needed.

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:

The product should not be used concurrently with any other medication containing acetaminophen, whether prescription or nonprescription. This is to prevent the risk of acetaminophen overdose.

Additionally, the product is contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such treatment. This is due to potential interactions that may lead to serious adverse effects. If there is uncertainty regarding the presence of an MAOI in a prescription medication, consultation with a healthcare professional is advised.

Warnings and Precautions

This product contains acetaminophen, which poses a risk of severe liver damage if not used according to the guidelines. Healthcare professionals should advise patients that the maximum daily dosage is 8 Softgels within a 24-hour period. Patients must be cautioned against concurrent use with other medications containing acetaminophen, as well as the consumption of three 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. Should any of these symptoms occur, patients must discontinue use immediately and seek medical assistance.

Sore Throat Warning 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 Patients should be instructed not to use this product in conjunction with any other medications containing acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in other medications, patients should consult a healthcare professional. Additionally, this product should not be used by individuals currently taking a prescription monoamine oxidase inhibitor (MAOI) or within two weeks of discontinuing such medication. Patients should be encouraged to verify with their healthcare provider or pharmacist if they are unsure about their current medications.

Monitoring and Consultation Patients should be advised to stop use and consult a healthcare professional if any of the following occur: pain or cough worsens or persists beyond seven days; fever worsens or lasts more than three days; redness or swelling is observed; new symptoms develop; or if cough recurs with a rash or headache that lasts. These symptoms may indicate a serious underlying condition.

Emergency Medical Help 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 without delay, even if no signs or symptoms are apparent. Quick intervention is essential for both adults and children.

Side Effects

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

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

Additionally, acetaminophen may cause severe skin reactions, which can manifest as skin reddening, blisters, or rash. If any of these symptoms occur, patients are advised to 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 consult a doctor promptly.

Patients should also stop use and contact a healthcare professional if pain or cough worsens or lasts longer than 7 days, if fever worsens or lasts more than 3 days, if redness or swelling is present, if new symptoms arise, or if a cough recurs with a rash or headache that persists, as these may indicate a serious condition.

Before using this product, patients with liver disease, glaucoma, or chronic respiratory conditions such as asthma, chronic bronchitis, or emphysema should consult a doctor. Those experiencing difficulty urinating due to an enlarged prostate gland should also seek medical advice prior to use.

Furthermore, patients taking sedatives, tranquilizers, or the blood-thinning medication warfarin should consult a doctor or pharmacist before using this product to avoid potential interactions.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Nighttime Cold and Flu Max Softgels (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 using this product. It is contraindicated in children under 4 years of age. For adults and children aged 12 years and older, the recommended dosage is 2 softgels with water every 6 hours.

Caution is advised when administering this product, as excitability may occur, particularly in pediatric patients.

Geriatric Use

Elderly patients, defined as those aged 65 and older, do not require specific dosage adjustments or present notable safety concerns based on the available data. However, it is essential for healthcare providers to consider general precautions when prescribing this medication to geriatric patients.

Patients in this age group should be advised to consult a healthcare professional prior to use if they have underlying conditions such as liver disease, glaucoma, respiratory issues, chronic cough, or urinary difficulties due to an enlarged prostate gland. These conditions may influence the safety and efficacy of the treatment in elderly patients.

Additionally, it is crucial for elderly patients to discuss any concurrent use of sedatives or tranquilizers with their doctor or pharmacist, as these substances can enhance drowsiness, posing a risk for this population.

Caution is also warranted regarding the consumption of alcohol in conjunction with this medication, as the combination with sedatives and tranquilizers may further increase drowsiness, which is particularly concerning for elderly patients. Regular monitoring and careful consideration of these factors are recommended to ensure the safe use of the medication in geriatric populations.

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 maternal and fetal safety.

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 not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring.

Hepatic Impairment

Patients with hepatic impairment should be aware of the potential risks associated with the use of 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 taking this product in conjunction with other medications that contain acetaminophen, as this can significantly increase the risk of severe liver damage.

Patients with compromised liver function are also advised to limit alcohol consumption. Specifically, the risk of severe liver damage is heightened if patients consume 3 or more alcoholic drinks daily while using this product.

Due to these considerations, careful monitoring of liver function is recommended for patients with hepatic impairment, and they should consult with a healthcare professional before using this product.

Overdosage

There is currently no specific information available regarding overdosage for this medication. In the absence of documented overdosage data, healthcare professionals are advised to exercise caution and monitor patients closely for any unusual symptoms or adverse effects that may arise following administration.

In the event of suspected overdosage, it is recommended that healthcare providers initiate supportive care and symptomatic treatment as necessary. Continuous monitoring of vital signs and clinical status is essential to ensure patient safety.

Healthcare professionals should also consider consulting a poison control center or a medical toxicologist for guidance on management strategies tailored to the individual patient's needs.

Nonclinical Toxicology

There is currently no available information regarding teratogenic or non-teratogenic effects associated with the substance. Additionally, no data has been provided concerning nonclinical toxicology, including animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions associated with the use of acetaminophen. Notably, severe skin reactions have been reported, which include symptoms such as skin reddening, blisters, and rash. In the event of a skin reaction, it is recommended that the use of acetaminophen be discontinued immediately, and medical assistance should be sought without delay.

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, it is crucial to seek medical help immediately or contact a Poison Control Center at 1-800-222-1222, as prompt medical attention is essential 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.

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 last two weeks. Patients should be encouraged to ask their healthcare provider or pharmacist if they are unsure whether their prescription medication contains an MAOI.

Patients should be advised to discontinue use and consult a doctor if their pain or cough worsens or persists for more than 7 days, if their fever worsens or lasts more than 3 days, if they notice any redness or swelling, or if new symptoms arise. Additionally, they should seek medical advice if a cough recurs or is accompanied by a rash or persistent headache, as these may indicate a serious condition.

While using this product, patients should be cautioned against exceeding the recommended dosage, as this may lead to increased excitability, particularly in children. Marked drowsiness may occur, and patients should be advised to avoid alcoholic beverages during treatment. They should also exercise caution when driving or operating machinery, as alcohol, sedatives, and tranquilizers can enhance drowsiness.

Patients with liver disease, glaucoma, a cough associated with excessive phlegm, chronic respiratory issues, or difficulty urinating due to an enlarged prostate should be encouraged to consult their doctor before using this product. Furthermore, patients 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 20-25°C (68-77°F) to maintain its efficacy. Care should be taken to avoid exposure to high humidity and excessive heat, as these conditions may compromise the product's integrity. Additionally, the product must be protected from light to ensure optimal stability and performance.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)