Daytime Cold and Flu Multi-Symptom Relief

Description

NDC 68016-877-16 identifies Premier Value's formulation, which is designed to provide multi-symptom relief for daytime cold and flu symptoms. Each capsule contains a combination of active ingredients: 325 mg of acetaminophen, 10 mg of dextromethorphan HBr, and 5 mg of phenylephrine HCl. This product is indicated for the relief of aches, fever, sore throat, nasal congestion, and cough. The formulation is presented in a capsule dosage form, with a total of 16 capsules per package.

Uses and Indications

This drug is indicated for the temporary relief of symptoms associated with the common cold and influenza. Specifically, it alleviates nasal congestion, cough due to minor throat and bronchial irritation, sore throat, headache, minor aches and pains, and fever.

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

Dosage and Administration

Patients should take the medication only as directed, adhering to the overdose warning. The maximum allowable dosage is four doses within a 24-hour period.

For adults and children aged 12 years and older, the recommended dosage is two capsules taken with water every four hours.

For children aged 4 to under 12 years, it is advised to consult a physician for appropriate dosing recommendations.

The medication is not indicated for use in children under 4 years of age.

When utilizing other Daytime or Nighttime products, it is essential to carefully read each label to ensure correct dosing and avoid exceeding the recommended limits.

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.

Additionally, it is important not to exceed the recommended dosage of this product.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen. Healthcare professionals should advise patients to adhere strictly to the following guidelines to mitigate the risk of liver injury:

• Do not exceed 4 doses within a 24-hour period, as this is the maximum daily amount for this product.

• Avoid concurrent use with other medications containing acetaminophen, whether prescription or nonprescription.

• Limit alcohol consumption to fewer than 3 drinks per day while using this product.

In addition, patients should be cautioned regarding the potential severity of sore throat symptoms. If a sore throat is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, patients should seek medical attention promptly.

General precautions must be observed to ensure safe use of this product:

• Patients should not use this product in conjunction with any other drug containing acetaminophen. If there is uncertainty regarding the presence of acetaminophen in other medications, patients are advised to consult a healthcare professional.

• This product should not be used by individuals currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such medication. Healthcare professionals should verify whether a patient’s prescription includes an MAOI before recommending this product.

Patients should be instructed to discontinue use and contact a healthcare provider if they experience any of the following:

• Nervousness, dizziness, or sleeplessness

• Worsening symptoms or symptoms that persist beyond 5 days in children or 7 days in adults

• Fever that worsens or lasts more than 3 days

• Presence of redness or swelling

• Onset of new symptoms

• Recurrence of cough, particularly if accompanied by a rash or persistent headache

In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted at 1-800-222-1222. Prompt medical attention is crucial for both adults and children, even if no signs or symptoms are initially apparent.

Side Effects

Patients using this product should be aware of potential adverse reactions, particularly those related to liver health and severe throat conditions. The product contains acetaminophen, which can lead to severe liver damage if the maximum daily dosage of 4 doses is exceeded within a 24-hour period, if it is taken concurrently with other medications containing acetaminophen, or if consumed alongside three or more alcoholic drinks daily.

In addition to liver-related concerns, patients should be vigilant for symptoms indicating a serious condition. If a sore throat is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, it is advised to seek medical attention promptly.

Patients are also instructed to discontinue use and consult a healthcare professional if they experience nervousness, dizziness, or sleeplessness. Other warning signs include worsening symptoms lasting more than five days in children or seven days in adults, fever that worsens or lasts more than three days, the presence of redness or swelling, the emergence of new symptoms, or a cough that recurs or is accompanied by a rash or headache.

Before using this product, patients should consult a doctor if they have a history of liver disease, heart disease, thyroid disease, diabetes, high blood pressure, or difficulty urinating due to an enlarged prostate gland. Additionally, those with a cough that produces excessive phlegm or a persistent cough associated with smoking, asthma, or emphysema should seek medical advice prior to use. It is also recommended that patients taking the blood-thinning medication warfarin consult with a healthcare provider or pharmacist before using this product.

Drug Interactions

Concurrent use of this medication with any other drug containing acetaminophen, whether prescription or nonprescription, is contraindicated due to the risk of acetaminophen overdose and potential hepatotoxicity.

The use of this medication is also contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) for depression, psychiatric or emotional conditions, or Parkinson's disease, as well as for a period of two weeks following the discontinuation of an MAOI. This combination may lead to serious adverse effects, including hypertensive crises.

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 Daytime Cold and Flu Multi-Symptom Relief (acetaminophen, dextromethorphan hydrobromide, 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 medication is not recommended for children under 4 years of age. For patients aged 12 years and older, the recommended dosage is 2 capsules with water every 4 hours.

Healthcare professionals should advise caregivers to monitor symptoms closely; if symptoms worsen or persist beyond 5 days in children or 7 days in adults, they should seek medical advice. Additionally, if a fever in pediatric patients worsens or lasts more than 3 days, medical consultation is necessary.

It is important to note that in cases of overdose, immediate medical attention is critical for both adults and children, even if no signs or symptoms are apparent.

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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in 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 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 no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the text. Therefore, healthcare professionals should exercise caution and consider individual patient factors when prescribing to this population. Regular assessment of renal function may be warranted to ensure safe and effective use of the medication in patients with reduced kidney function.

Hepatic Impairment

Patients with hepatic impairment should exercise caution when using this product, which contains acetaminophen. It is critical to adhere to the maximum daily dosage of 4 doses within a 24-hour period, as exceeding this limit may result in severe liver damage.

Additionally, patients must be aware that the concurrent use of this product with other medications containing acetaminophen can significantly increase the risk of severe liver damage.

Furthermore, individuals who consume three or more alcoholic drinks daily should avoid using this product, as this combination may also lead to severe liver damage. Regular monitoring of liver function is recommended for patients with compromised liver function to ensure safety and efficacy while using this product.

Overdosage

In cases of overdosage, significant health risks are associated with the consumption of this product beyond the recommended limits.

Risk of Severe Liver Damage Healthcare professionals should be aware that severe liver damage may occur if a patient exceeds four doses within a 24-hour period, which is the maximum daily amount for this product. Additionally, the concomitant use of this product with other medications containing acetaminophen can also lead to severe liver damage.

Furthermore, patients who consume three or more alcoholic drinks daily while using this product are at an increased risk of experiencing severe liver damage.

Recommended Actions In the event of suspected overdosage, it is imperative to assess the patient's liver function and consider immediate medical intervention. Monitoring of liver enzymes and supportive care may be necessary, depending on the severity of the symptoms and the extent of the overdosage. Prompt recognition and management are crucial to mitigate potential complications associated with liver injury.

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. Additionally, there are no detailed findings related to nonclinical toxicology or animal pharmacology and toxicology available.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions reported voluntarily or through surveillance programs.

Allergic reactions have been noted, including cases of anaphylaxis and angioedema. Hepatotoxicity has also been reported, with instances of severe liver injury documented. Skin reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis, have been observed.

Additionally, cardiovascular events, including hypertension and arrhythmias, have been recorded. Gastrointestinal events, particularly nausea and vomiting, have been reported as well. Neurological events, including dizziness and confusion, have also been noted in the postmarketing data.

Patient Counseling

Healthcare providers should advise patients about the potential risks associated with overdose, emphasizing that taking more than the directed dose can lead to serious health problems. In the event of an overdose, patients should seek medical help immediately or contact a Poison Control Center 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 whether a drug contains acetaminophen, they should be encouraged to consult a doctor or pharmacist.

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 within two weeks of stopping such medication. Patients should be advised to check with their healthcare provider if they are unsure whether their prescription includes an MAOI.

Patients should be instructed to discontinue use and consult a doctor if they experience nervousness, dizziness, or sleeplessness. Additionally, they should seek medical advice if their symptoms worsen or persist beyond five days for children or seven days for adults. If fever worsens or lasts more than three days, or if redness or swelling occurs, patients should also stop use and contact a healthcare professional. New symptoms or a returning cough, especially if accompanied by a rash or persistent headache, should prompt patients to seek medical attention, as these may indicate a serious condition.

While using this product, patients must adhere strictly to the recommended dosage. Healthcare providers should encourage patients to consult a doctor before use if they have any of the following conditions: liver disease, heart disease, thyroid disease, diabetes, high blood pressure, or difficulty urinating due to an enlarged prostate gland. Patients with a cough that produces excessive phlegm or a persistent cough associated with smoking, asthma, or emphysema should also seek medical advice prior to use. 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 to maintain its integrity and efficacy. Proper handling should be observed to ensure optimal conditions are met throughout the storage period.

Additional Clinical Information

The medication is administered orally, with the recommended dosage for adults and children aged 12 years and older being 2 capsules taken with water every 4 hours. For children aged 4 to under 12 years, it is advised to consult a doctor regarding appropriate use, while the medication is not recommended for children under 4 years of age.

Clinicians should counsel patients to seek advice from a health professional if they are pregnant or breastfeeding. It is crucial 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 attention is essential for both adults and children, even if no symptoms are apparent.

Drug Information (PDF)

This file contains official product information for Daytime Cold and Flu Multi-Symptom Relief, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)