Maximum Strength Non Drowsy Daytime Severe Cold and Flu

Description

This formulation contains acetaminophen, a pain reliever and fever reducer, dextromethorphan hydrobromide, a cough suppressant, guaifenesin, an expectorant, and phenylephrine hydrochloride, a nasal decongestant. The product is presented in a dosage form of softgels, with a total of 20 softgels per package. Each active ingredient contributes to the overall therapeutic effect, targeting pain relief, cough suppression, mucus clearance, and nasal congestion.

Uses and Indications

This drug is indicated for the temporary relief of symptoms associated with the common cold and influenza. Specifically, it provides relief from minor aches and pains, headache, sore throat, nasal congestion, and cough. Additionally, this drug aids in loosening phlegm (mucus) and thinning bronchial secretions, thereby enhancing the productivity of coughs. It also temporarily reduces fever and alleviates symptoms such as headache, body pain, sore throat, chest congestion, nasal congestion, sinus congestion, and sinus pressure.

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

Dosage and Administration

Adults and children aged 12 years and over are instructed to take 2 caplets every 4 hours as needed. The caplets should be swallowed whole and must not be crushed, chewed, or dissolved to ensure proper release and absorption of the medication. It is important to note that the total dosage should not exceed 10 caplets within a 24-hour period.

For children under 12 years of age, it is recommended to consult a physician for appropriate dosing guidance.

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.

• In patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such medication, as this may lead to serious drug interactions.

• In individuals with a history of allergic reactions to this product or any of its ingredients, to prevent potential anaphylactic reactions.

Healthcare professionals should ensure that patients are aware of these contraindications prior to prescribing or recommending this product.

Warnings and Precautions

This product contains acetaminophen, which necessitates careful monitoring due to the potential for severe liver damage. The maximum recommended daily dosage is 10 caplets (3,250 mg of acetaminophen) within a 24-hour period. Healthcare professionals should advise patients against exceeding 4,000 mg of acetaminophen in 24 hours, using other medications that contain acetaminophen concurrently, or consuming three or more alcoholic beverages daily while using this product.

Allergy Alert Acetaminophen may induce severe skin reactions, which can manifest as skin reddening, blisters, or 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 instructed to consult a healthcare provider promptly.

General Precautions Prior to use, patients should be advised to consult a healthcare professional if they have any of the following conditions: liver disease, heart disease, high blood pressure, thyroid disease, diabetes, difficulty urinating due to an enlarged prostate gland, or a persistent or chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema. Additionally, patients taking the anticoagulant warfarin should seek guidance from a doctor or pharmacist before using this product.

Emergency Medical Help In the event of an overdose, immediate medical attention is crucial. Patients should be instructed to contact a Poison Control Center at 1-800-222-1222, as prompt intervention is essential for both adults and children, even in the absence of noticeable symptoms.

Discontinuation of Use Patients should stop taking this product and contact a healthcare provider if they experience nervousness, dizziness, or sleeplessness; if pain, nasal congestion, or cough worsens or persists beyond seven days; if fever worsens or lasts more than three days; if redness or swelling occurs; if new symptoms develop; or if a cough recurs or is accompanied by a rash or headache lasting longer than expected. These symptoms may indicate a serious underlying condition that requires further evaluation.

Side Effects

Patients using this product should be aware of several potential adverse reactions, which can be categorized by seriousness and frequency.

Severe adverse reactions include significant liver damage, which may occur if the maximum daily dose of acetaminophen exceeds 4,000 mg, if the product is taken in conjunction with other medications containing acetaminophen, or if the patient consumes three or more alcoholic drinks daily while using this product. Patients should be vigilant for symptoms of severe skin reactions, which may manifest as skin reddening, blisters, or rash. In the event of such a reaction, it is imperative to discontinue use and seek medical assistance immediately.

Common adverse reactions that warrant discontinuation of use and consultation with a healthcare provider include nervousness, dizziness, or sleeplessness. Additionally, if pain, nasal congestion, or cough worsens or persists beyond seven days, or if fever intensifies or lasts more than three days, medical advice should be sought. Patients should also be alert for signs of 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, as these may indicate a serious underlying condition.

Before using this product, patients with pre-existing conditions such as liver disease, heart disease, high blood pressure, thyroid disease, diabetes, or urinary difficulties due to an enlarged prostate gland should consult a healthcare professional. Furthermore, individuals with a persistent or chronic cough, particularly those associated with smoking, asthma, chronic bronchitis, or emphysema, should also seek medical advice prior to use. Patients taking the anticoagulant warfarin should consult a doctor or pharmacist before using this product to avoid potential interactions.

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, which can lead to severe liver damage.

The use of this medication is also contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. Additionally, it should not be administered within 2 weeks of discontinuing an MAOI, as this may lead to serious adverse effects.

Patients taking the anticoagulant warfarin should consult with a healthcare professional, such as a doctor or pharmacist, prior to using this medication. Monitoring of coagulation parameters may be necessary to ensure safe use and to avoid potential interactions that could affect bleeding risk.

Packaging & NDC

Below are the non-prescription pack sizes of Maximum Strength Non Drowsy Daytime Severe Cold and Flu (acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional before use. For adolescents aged 12 years and older, the recommended dosage is 2 caplets every 4 hours, with a maximum of 10 caplets in a 24-hour period. Caution is advised when administering to younger children, and appropriate medical guidance is essential.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. 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 maternal health. 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 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 no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data necessitates careful clinical judgment.

Hepatic Impairment

Patients with hepatic impairment should be closely monitored when using this product, which contains acetaminophen. The maximum daily dose is limited to 10 caplets (3,250 mg of acetaminophen) within a 24-hour period. It is critical to note that severe liver damage may occur if patients exceed 4,000 mg of acetaminophen in 24 hours, use other medications containing acetaminophen concurrently, or consume three or more alcoholic drinks daily while using this product.

Patients with a history of liver disease are advised to consult a healthcare professional prior to use to assess the appropriateness of this product and to discuss potential risks associated with acetaminophen. Regular monitoring of liver function may be warranted in these patients to prevent adverse effects.

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 lack of immediate symptoms does not preclude the potential for serious adverse effects. Therefore, vigilance and timely medical evaluation are essential in managing overdose situations effectively.

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

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 advised 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, patients should be instructed to 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 apparent.

Patients should be cautioned against using this product in conjunction with any other medications that contain acetaminophen, whether prescription or nonprescription. If patients are uncertain about the presence of acetaminophen in their other medications, they should consult a doctor or pharmacist for clarification.

It is important to inform patients that this product should not be used if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have taken one 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 with a history of allergic reactions to this product or any of its ingredients should be advised not to use it. They should also be instructed to discontinue use and consult a doctor if they experience nervousness, dizziness, or sleeplessness.

Healthcare providers should inform patients to stop using the product and seek medical advice if pain, nasal congestion, or cough worsens or persists for more than seven days. Additionally, patients should be advised to contact a doctor if fever worsens or lasts more than three days, or if they notice any redness or swelling. New symptoms that arise during use should also prompt a consultation with a healthcare provider.

Patients should be warned to stop using the product and seek medical attention if a cough returns or occurs alongside a rash or headache that persists, as these may indicate a serious condition. It is essential to emphasize that patients should not exceed the recommended dosage while using this product.

Before using this medication, patients should be encouraged to consult a doctor if they have liver disease, heart disease, high blood pressure, thyroid disease, diabetes, difficulty urinating due to an enlarged prostate gland, or a persistent or chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema. Patients with a cough that produces excessive phlegm should also seek medical advice prior to use.

Finally, patients taking the blood-thinning medication warfarin should be advised to consult a doctor or pharmacist before using this product to ensure safety and avoid potential interactions.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It should be stored at a controlled room temperature of 25ºC (77ºF). Temporary excursions from this temperature are permissible, provided they remain within the range of 15ºC to 30ºC (59ºF to 86ºF). Proper container requirements must be adhered to, ensuring that the product is protected from excessive heat and moisture. Special handling considerations should be observed to maintain the integrity of the product throughout its storage period.

Additional Clinical Information

The medication is administered orally. For adults and children aged 12 years and older, the recommended dosage is 2 caplets every 4 hours, with a maximum of 10 caplets in a 24-hour period. Patients should swallow the caplets whole and avoid crushing, chewing, or dissolving them. For children under 12 years, it is advised to consult a doctor for appropriate dosing.

Clinicians should counsel patients to seek advice from a health professional if they are pregnant or breastfeeding. It is important to keep the medication out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center contacted at 1-800-222-1222, as prompt medical attention is crucial for both adults and children, even if no symptoms are apparent.

Drug Information (PDF)

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

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