Maximum Strength Nighttime Severe Cold and Flu

Uses and Indications

This drug is indicated for the temporary relief of symptoms associated with the common cold and influenza. It is effective in alleviating nasal congestion, sinus congestion and pressure, cough due to minor throat and bronchial irritation, and cough that may interfere with sleep. Additionally, it provides relief from minor aches and pains, headache, fever, sore throat, runny nose, and sneezing.

This medication also reduces swelling of the nasal passages, temporarily restores freer breathing through the nose, and promotes nasal and/or sinus drainage.

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

Dosage and Administration

Patients should take the medication 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

This product contains acetaminophen, which carries a significant 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 and the consumption of three or more alcoholic drinks daily while using this product.

Severe skin reactions may occur in individuals allergic to acetaminophen. Symptoms of such reactions can include skin reddening, blisters, and rash. If any of these symptoms manifest, 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 is 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, individuals should consult a healthcare provider if they have liver disease, heart disease, high blood pressure, thyroid disease, diabetes, glaucoma, a cough associated with excessive phlegm, or any breathing problems, including chronic cough, smoking-related issues, asthma, chronic bronchitis, or emphysema. Additionally, patients experiencing difficulty urinating due to an enlarged prostate gland should seek medical advice before use.

Patients should also consult a doctor or pharmacist if they are currently taking sedatives, tranquilizers, or the anticoagulant warfarin, as these medications may interact adversely with acetaminophen.

In the event of an overdose, immediate medical attention is crucial. Patients should be instructed to contact a Poison Control Center or seek emergency medical help without delay, as rapid intervention is essential for both adults and children, even in the absence of noticeable symptoms.

Patients should discontinue use and contact a healthcare provider if they experience nervousness, dizziness, or sleeplessness. Additionally, if pain, nasal congestion, or cough worsens or persists beyond seven days, or if fever worsens or lasts more than three days, medical consultation is warranted. Redness, swelling, the emergence of new symptoms, or a cough that recurs with a rash or headache should also prompt immediate medical evaluation, as these may indicate a serious underlying condition.

Side Effects

Severe liver damage may occur in patients taking this product containing acetaminophen if they exceed the maximum daily amount of 8 softgels within 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.

In cases of severe sore throat that persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, patients are advised to consult a healthcare professional promptly.

While using this product, excitability may occur, particularly in children. Marked drowsiness is also a potential adverse reaction; therefore, patients are cautioned to avoid alcoholic beverages and to exercise caution when driving or operating machinery. The concomitant use of alcohol, sedatives, and tranquilizers may exacerbate drowsiness.

Patients should discontinue use and consult a doctor if they experience nervousness, dizziness, or sleeplessness. Additionally, if pain, nasal congestion, or cough worsens or persists beyond 7 days, or if fever worsens or lasts more than 3 days, medical advice should be sought. Signs such as redness or swelling, the emergence of new symptoms, or a cough that recurs or is accompanied by a rash or headache lasting longer than expected may indicate a serious condition requiring medical evaluation.

Drug Interactions

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

The use of this product is also contraindicated 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, and Parkinson's disease. Patients should verify with a healthcare provider if they are unsure whether their prescription includes an MAOI.

Caution is advised when using this product in conjunction with sedatives or tranquilizers. Patients are encouraged to seek guidance from a healthcare professional prior to use.

Additionally, patients taking the anticoagulant warfarin should consult a healthcare provider before using this product, as interactions may occur.

It is important to note that the concurrent use of alcohol, sedatives, and tranquilizers may enhance drowsiness, and patients should be advised to exercise caution in such situations.

Packaging & NDC

Below are the non-prescription pack sizes of Maximum Strength Nighttime Severe Cold and Flu (acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride). 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.

When using this product, excitability may occur, particularly in children. It is essential to keep the product out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center. Prompt medical attention is crucial for both adults and children, even if no signs or symptoms are apparent.

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 potential 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 should consider individual circumstances and the specific health needs of the patient when making recommendations.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is no specific data available regarding the excretion of this medication in 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 drug insert regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment should exercise caution when using this product, particularly those with liver disease. It is advisable for these patients to consult a healthcare professional prior to use.

This product contains acetaminophen, which carries a risk of severe liver damage. Patients with compromised liver function must be aware of the following critical guidelines to mitigate this risk:

• The maximum recommended dosage is 8 softgels within a 24-hour period. Exceeding this limit may lead to severe liver damage.

• Patients should avoid concurrent use of other medications that contain acetaminophen, as this can further increase the risk of liver injury.

• Consumption of 3 or more alcoholic drinks daily while using this product is contraindicated, as it may exacerbate the potential for liver damage.

Monitoring of liver function may be warranted in patients with hepatic impairment who are prescribed this product, and any signs of liver dysfunction should prompt immediate medical evaluation.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Prompt intervention is crucial for both adults and children, even in the absence of observable signs or symptoms.

Healthcare professionals are advised to remain vigilant, as the lack of immediate symptoms does not preclude the potential for serious health consequences. Therefore, timely evaluation and management are essential to mitigate risks associated with overdose situations.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to use. No specific non-teratogenic effects have been identified in the available data. Additionally, there are no detailed findings regarding nonclinical toxicology or animal pharmacology and toxicology provided in the current information.

Postmarketing Experience

No specific postmarketing experience details have been reported. As such, there are no additional adverse events or rare case reports to summarize at this time.

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 or contact a Poison Control Center immediately, as prompt medical attention is crucial for both adults and children, even if no signs or symptoms are apparent.

Patients should be instructed 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 inform patients that they should not 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 they experience nervousness, dizziness, or sleeplessness. Additionally, they should seek medical advice if pain, nasal congestion, or cough worsens or persists for more than seven days, if fever worsens or lasts more than three days, or if they notice any redness or swelling. New symptoms that arise should also prompt a consultation with a healthcare provider. Patients should be particularly vigilant for a returning cough or one that occurs with a rash or headache lasting longer than usual, as these may indicate a serious condition.

When using this product, patients must adhere strictly to the recommended dosage and be aware that excitability may occur, especially in children. Marked drowsiness is a potential side effect; therefore, patients should avoid alcoholic beverages and exercise caution when driving or operating machinery. The use of alcohol, sedatives, and tranquilizers may exacerbate drowsiness.

Patients should be encouraged to consult a doctor before using this product if they have any of the following conditions: liver disease, heart disease, high blood pressure, thyroid disease, diabetes, glaucoma, or a cough accompanied by excessive phlegm. Those with breathing problems or chronic coughs related to smoking, asthma, chronic bronchitis, or emphysema should also seek medical advice prior to use. Furthermore, patients experiencing difficulty urinating due to an enlarged prostate gland should consult their healthcare provider. Lastly, patients taking sedatives, tranquilizers, or the blood-thinning medication warfarin should discuss their use of this product with a doctor or pharmacist.

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 in a controlled environment, ensuring that the temperature does not exceed 25°C (77°F). Proper container requirements must be adhered to, and special handling needs should be observed to maintain product integrity.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

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