Non Drowsy Daytime and Nighttime Sinus Congestion and Cough Relief

Description

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

Uses and Indications

This drug is indicated for the temporary relief of non-drowsy daytime symptoms associated with sinus congestion and cough due to colds or flu. Specifically, it alleviates minor aches and pains, headache, cough, sore throat, and nasal and sinus congestion. Additionally, this drug 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 with water every 4 hours as needed. The maximum allowable dosage is 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.

Contraindications

Use of this product is contraindicated in the following situations:

• Co-administration with any other drug containing acetaminophen, whether prescription or nonprescription, due to the risk of acetaminophen overdose.

• Concurrent use with prescription monoamine oxidase inhibitors (MAOIs) or within 2 weeks of discontinuing an MAOI, as this may lead to serious drug interactions.

• History of allergic reaction to this product or any of its ingredients, which may result in severe hypersensitivity reactions.

• In children under 12 years of age, due to safety concerns and lack of established efficacy in this population.

Warnings and Precautions

Severe liver damage may occur with the use of products containing acetaminophen if the following conditions are met: exceeding 4000 mg of acetaminophen within a 24-hour period, concurrent use with other medications containing acetaminophen, or consumption of three or more alcoholic drinks daily while using this product.

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

Acetaminophen may also lead to severe skin reactions, which can manifest as skin reddening, blisters, or rash. Should any skin reaction occur, the product should be discontinued immediately, and medical assistance should be sought without delay.

Healthcare professionals should advise patients to consult a doctor prior to use if they have any of the following conditions: liver disease, heart disease, high blood pressure, thyroid disease, diabetes, cough with excessive phlegm, difficulty urinating due to prostate gland enlargement, or a persistent or chronic cough associated with smoking, asthma, or emphysema. Additionally, patients taking the anticoagulant warfarin should seek guidance from a doctor or pharmacist before using this product.

In the event of an overdose, immediate medical attention is crucial. Patients should contact a Poison Control Center or seek emergency medical help right away, as prompt intervention is essential for both adults and children, even in the absence of noticeable symptoms.

Patients should discontinue use and contact their healthcare provider if any of the following occur: worsening pain, cough, or nasal congestion lasting more than seven days; fever that worsens or persists beyond three days; presence of redness or swelling; emergence of new symptoms; recurrence of cough accompanied by rash or headache lasting for an extended period; or the onset of nervousness, dizziness, or sleeplessness. These symptoms may indicate a serious underlying condition that requires further evaluation.

Side Effects

Severe liver damage may occur in patients who exceed 4000 mg of acetaminophen within a 24-hour period, which is the maximum daily dosage for this product. The risk of liver damage is heightened when acetaminophen is taken in conjunction with other medications containing acetaminophen or when patients consume three or more alcoholic drinks daily while using this product.

Patients should be aware of the potential for severe skin reactions associated with acetaminophen use. Symptoms may include skin reddening, blisters, and rash. If any skin reaction occurs, patients are advised to discontinue use and seek medical assistance immediately.

In clinical practice, patients are encouraged to consult a healthcare provider if they experience a sore throat that is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting. Additionally, patients should stop use and seek medical advice if pain, cough, or nasal congestion worsens or lasts longer than seven days, if fever worsens or lasts more than three days, if redness or swelling is present, if new symptoms arise, or if a cough recurs with a rash or headache that persists. Symptoms such as nervousness, dizziness, or sleeplessness should also prompt patients to consult a healthcare professional.

Patients with pre-existing conditions such as liver disease, heart disease, high blood pressure, thyroid disease, diabetes, or those experiencing a cough with excessive phlegm or difficulty urinating due to prostate enlargement should seek medical advice before using this product. Furthermore, individuals with a persistent or chronic cough, such as that associated with smoking, asthma, or emphysema, should also consult a healthcare provider prior to use.

In the event of an overdose, it is critical for patients to seek medical help or contact a Poison Control Center immediately, as prompt medical attention is essential for both adults and children, even if no signs or symptoms are initially apparent.

Drug Interactions

Co-administration of this product with any other medication containing acetaminophen, whether prescription or nonprescription, is contraindicated. Patients should be advised to 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 conditions, or Parkinson's disease. Patients should seek guidance from a healthcare provider if they are unsure whether their prescription includes an MAOI.

Caution is advised when using this product in conjunction with warfarin, a blood-thinning medication. Patients should consult a healthcare professional prior to use to assess potential interactions and the need for monitoring.

Additionally, the concurrent use of this product with sedatives or tranquilizers warrants consultation with a healthcare provider. The combination of alcohol, sedatives, and tranquilizers may enhance drowsiness, and patients should be informed of this risk to ensure safe usage.

Packaging & NDC

Below are the non-prescription pack sizes of Non Drowsy Daytime and Nighttime Sinus Congestion and Cough Relief (acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should not use this medication. Prior to administration, it is essential to consult a healthcare professional if the child has any of the following conditions: liver disease, heart disease, high blood pressure, thyroid disease, diabetes, cough with excessive phlegm, difficulty urinating due to prostate enlargement, or a persistent or chronic cough associated with smoking, asthma, or emphysema.

This medication is not indicated for the sedation of children. Quick medical attention is critical for both adults and pediatric patients, even in the absence of noticeable signs or symptoms.

Geriatric Use

Elderly patients should consult a healthcare provider prior to using this product, particularly if they have a history of liver disease, heart disease, high blood pressure, thyroid disease, diabetes, cough with excessive phlegm, difficulty urinating due to prostate enlargement, or persistent cough associated with smoking, asthma, or emphysema.

Additionally, it is important for geriatric patients to seek advice from a doctor or pharmacist if they are concurrently taking the anticoagulant warfarin, as interactions may occur.

Elderly patients are advised to adhere strictly to the recommended dosage, as exceeding this may lead to adverse effects. The product may cause significant drowsiness; therefore, it is recommended that elderly patients avoid the consumption of alcoholic beverages. The use of alcohol, sedatives, and tranquilizers can further enhance drowsiness, necessitating caution when driving or operating machinery.

Prompt medical attention is essential for elderly patients, as well as for children, even in the absence of noticeable signs or symptoms.

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 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 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 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 exercise caution when using this product, as it contains acetaminophen, which is associated with the risk of severe liver damage. It is critical that patients do not exceed the maximum daily dosage of 4000 mg of acetaminophen within a 24-hour period. Additionally, patients should avoid concomitant use of other medications containing acetaminophen, as this may further increase the risk of liver injury.

Patients with compromised liver function are advised to consult a healthcare professional prior to using this product, particularly if they have a history of liver disease. Furthermore, consumption of three or more alcoholic drinks per day while using this product is strongly discouraged, as it may exacerbate the risk of liver damage. Regular monitoring of liver function may be warranted in patients with existing liver conditions to ensure safety and efficacy during treatment.

Overdosage

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

Healthcare professionals should be aware that the lack of immediate symptoms does not preclude the potential for serious health consequences. Therefore, it is essential to monitor the patient closely and provide appropriate care as directed by medical guidelines.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to use.

Marked drowsiness may occur with the use of this product. The concomitant use of alcohol, sedatives, and tranquilizers has the potential to enhance drowsiness. Additionally, excitability may be observed, particularly in pediatric populations.

No specific information regarding nonclinical toxicology or animal pharmacology and toxicology is available in the insert.

Postmarketing Experience

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

Additionally, excitability has been noted as a possible adverse event, particularly in pediatric populations.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center in the event of an overdose, as prompt medical attention is crucial 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 about the presence of acetaminophen in their medications, they should be encouraged to 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) or have stopped taking an MAOI within the past two weeks. Patients should be advised to verify with a healthcare professional if they are unsure whether their prescription includes an MAOI.

Patients with a history of allergic reactions to this product or any of its ingredients should be cautioned against its use. Additionally, this product is not recommended for children under 12 years of age.

Patients should be instructed to discontinue use and consult a doctor if their pain, cough, or nasal congestion worsens or persists for more than 7 days, or if their fever worsens or lasts longer than 3 days. They should also seek medical advice if they notice any redness or swelling, experience new symptoms, or if a cough returns or occurs alongside a rash or headache that lasts, as these may indicate a serious condition. Furthermore, patients should stop use and consult a doctor if they experience nervousness, dizziness, or sleeplessness.

Healthcare providers should emphasize the importance of adhering to the recommended dosage and advise patients to consult a doctor before use if they have any of the following conditions: liver disease, heart disease, high blood pressure, thyroid disease, diabetes, cough with excessive phlegm, difficulty urinating due to prostate enlargement, or a persistent or chronic cough associated with smoking, asthma, or emphysema. Lastly, patients taking the blood-thinning medication warfarin should be advised to consult a doctor or pharmacist before using this product.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers assigned for identification. It is essential to store the product at room temperature, ensuring that it is protected from excessive heat to maintain its integrity and efficacy. Proper handling and storage conditions are crucial for preserving the quality of the product throughout its shelf life.

Additional Clinical Information

Adults and children aged 12 years and over are advised to take 2 softgels with water every 4 hours, with a maximum of 10 softgels in a 24-hour period unless directed otherwise by a healthcare professional.

Clinicians should counsel patients to consult a health professional if they are pregnant or breastfeeding. It is important to keep the product out of reach of children. In the event of an overdose, patients should seek immediate medical assistance or contact a Poison Control Center, 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 Non Drowsy Daytime and Nighttime Sinus Congestion and Cough Relief, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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