Maximum Strenth Night Cold and Flu Formula

Description

The product is identified by the SPL code 34089-3 and is available in a dosage form of 8 count (CT).

Uses and Indications

This drug is indicated for the temporary relief of symptoms associated with the common cold or influenza. Specifically, it alleviates minor aches and pains, headache, cough, sore throat, and nasal and sinus congestion. Additionally, it temporarily reduces fever.

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

Dosage and Administration

Adults and children aged 12 years and older are instructed to take 2 softgels orally 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.

Use is not recommended for children under 12 years of age. It is essential to adhere to the recommended dosage and not exceed the specified limits to ensure safety and efficacy.

Contraindications

There are no specific contraindications listed for this product. However, it is essential to keep the product out of reach of children to prevent accidental ingestion. In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center at 1-800-222-1222. Prompt medical attention is crucial for both adults and children, even if no signs or symptoms are apparent.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen. Healthcare professionals should advise patients to avoid exceeding 4,000 mg of acetaminophen within a 24-hour period. Caution is also warranted when this product is taken in conjunction with other medications containing acetaminophen or when patients consume three or more alcoholic drinks daily while using this product.

Acetaminophen has the potential to induce severe skin or allergic reactions. Symptoms indicative of such reactions may include skin reddening, blisters, rash, hives, facial swelling, wheezing, and shock. In the event of any skin or general allergic reaction, patients should be instructed to discontinue use immediately and seek medical assistance.

In cases of severe sore throat, particularly if it persists for more than two days or is accompanied by fever, headache, rash, nausea, or vomiting, patients should be advised to consult a healthcare provider promptly.

In the event of an overdose, it is imperative to seek emergency medical help or contact a Poison Control Center immediately at 1-800-222-1222. Rapid medical intervention is crucial for both adults and children, even if no signs or symptoms are initially apparent.

Patients should be instructed to stop taking the product and contact their healthcare provider if any signs of a skin or general allergic reaction occur.

Side Effects

Severe liver damage may occur in patients who exceed a dosage of 4,000 mg of acetaminophen within a 24-hour period, use other medications containing acetaminophen concurrently, or consume three or more alcoholic drinks daily while using this product.

Patients should be aware of the potential for severe skin or allergic reactions associated with acetaminophen. Symptoms of such reactions may include skin reddening, blisters, rash, hives, facial swelling, asthma (wheezing), and shock. In the event of a skin or general allergic reaction, it is imperative that patients discontinue use and seek medical assistance immediately.

Additionally, if a patient experiences a sore throat that is severe, persists for more than two days, or is accompanied or followed by fever, headache, rash, nausea, or vomiting, they should consult a healthcare professional promptly.

Drug Interactions

Severe liver damage may occur with the concomitant use of acetaminophen and other products containing acetaminophen. It is advised that the total daily dosage of acetaminophen should not exceed 4,000 mg to minimize the risk of hepatotoxicity. Additionally, patients consuming three or more alcoholic beverages daily while using this product are at an increased risk for severe liver damage.

No specific drug or laboratory test interactions have been identified in the available data. Monitoring of liver function may be warranted in patients at risk for hepatotoxicity, particularly those exceeding recommended dosages or with significant alcohol consumption.

Packaging & NDC

Below are the non-prescription pack sizes of Maximum Strenth Night Cold and Flu Formula (acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should not use this medication. For individuals aged 12 years and older, the recommended dosage is 2 softgels taken with water every 4 hours, with a maximum of 10 capsules in a 24-hour period, unless otherwise directed by a healthcare professional.

It is essential to keep this medication out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center at 1-800-222-1222. Prompt medical attention is crucial for both adults and children, even if no signs or symptoms of overdose are 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

The safety of this product during pregnancy has not been established. This product is contraindicated in pregnancy due to potential risks to the fetus. Pregnant women should consult a healthcare provider before using this product to discuss potential risks and benefits.

Lactation

Nursing mothers should consult a healthcare professional before using this product. There is a potential for excretion in breast milk, and caution is advised due to the possibility of adverse effects in nursing infants.

Renal Impairment

There is no specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in this patient population.

Hepatic Impairment

Patients with hepatic impairment should exercise caution when using this product, which contains acetaminophen. It is important to note that severe liver damage may occur if patients exceed the following limits:

• More than 4,000 mg of acetaminophen in a 24-hour period.

• Concurrent use with other medications that contain acetaminophen.

• Consumption of three or more alcoholic drinks daily while using this product.

Due to the potential for increased risk of liver toxicity, patients with compromised liver function should be closely monitored for signs of liver damage. It is advisable for these patients to consult with a healthcare professional before using this product to ensure safe and appropriate use.

Overdosage

In cases of overdosage, significant health risks are associated with the consumption of acetaminophen.

Risk of Severe Liver Damage Healthcare professionals should be aware that severe liver damage may occur if an individual ingests more than 4,000 mg of acetaminophen within a 24-hour period. Additionally, the risk of liver damage is heightened when acetaminophen is taken concurrently with other medications that also contain acetaminophen.

Furthermore, the consumption of three or more alcoholic beverages daily while using acetaminophen can exacerbate the risk of severe liver damage.

Recommended Actions In the event of suspected overdosage, it is imperative to seek immediate medical attention. Healthcare providers should assess the patient's condition and consider the administration of activated charcoal if the ingestion occurred within a suitable timeframe. Monitoring liver function tests and providing supportive care are essential components of management.

Prompt recognition and intervention are critical to mitigate the potential consequences of acetaminophen overdosage.

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 several adverse reactions associated with the use of the product. Reports have included severe skin reactions, such as skin reddening, blisters, rash, hives, and facial swelling. Additionally, severe allergic reactions have been noted, including symptoms of asthma (wheezing) and shock.

In the event of a skin or general allergic reaction, it is advised to discontinue use immediately and seek medical assistance.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. It is essential to emphasize the importance of seeking immediate medical assistance in the event of an overdose. Patients should be instructed to contact a Poison Control Center at 1-800-222-1222 or seek medical help right away, regardless of whether they observe any signs or symptoms. Quick medical attention is critical for both adults and children in such situations.

Storage and Handling

The product is supplied in a container that must be kept tightly closed to maintain integrity. It should be stored at a temperature range of 20°C to 25°C (68°F to 77°F), with permissible excursions between 15°C to 30°C (59°F to 86°F). It is essential to protect the product from light to prevent degradation. Additionally, the product should be discarded after opening to ensure safety and efficacy.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients to keep the medication out of reach of children. In the event of an overdose, it is crucial to seek medical assistance or contact a Poison Control Center immediately at 1-800-222-1222. Prompt medical attention is essential for both adults and children, even if no signs or symptoms are apparent.

Drug Information (PDF)

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

View product document (PDF)