Daytime Nighttime Cold Flu Relief

Description

Acetaminophen 325 mg serves as a pain reliever and fever reducer. Dextromethorphan HBr 10 mg functions as a cough suppressant, while phenylephrine HCl 5 mg acts as a nasal decongestant. This formulation is designed to relieve symptoms associated with aches, fever, sore throat, cough, and nasal congestion. The product is presented in softgel form, specifically liquid-filled capsules, and is characterized as non-drowsy, alcohol-free, and antihistamine-free.

Uses and Indications

This drug is indicated for the temporary relief of common cold and flu symptoms in adults and children.

During daytime use, it alleviates symptoms including cough due to minor throat and bronchial irritation, nasal congestion, headache, minor aches and pains, fever, and sore throat.

For nighttime use, it provides relief from similar symptoms, specifically targeting cough due to minor throat and bronchial irritation, sore throat, headache, minor aches and pains, fever, as well as runny nose and sneezing.

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

Dosage and Administration

For daytime use, adults and children aged 12 years and older are instructed to take 2 softgels with water every 4 hours, not exceeding 4 doses within a 24-hour period. It is essential to swallow the softgels whole; they should not be crushed, chewed, or dissolved. The product is not recommended for children under 12 years of age.

For nighttime use, adults and children aged 12 years and older should take 2 softgels with water every 6 hours, again ensuring that no more than 4 doses are taken in a 24-hour period. Similar to daytime instructions, the softgels must be swallowed whole and must not be crushed, chewed, or dissolved. This product is also not suitable for children under 12 years.

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

Severe liver damage may occur with the use of products containing acetaminophen if the following conditions are met: exceeding 4,000 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 these products.

Acetaminophen may also cause severe skin reactions, which can manifest as skin reddening, blisters, or rash. In the event of a skin reaction, it is imperative to discontinue use immediately and seek medical assistance.

Healthcare professionals should advise patients to consult a doctor promptly if a sore throat is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting.

When utilizing this product, it is crucial to adhere to the recommended dosage to avoid potential complications. Patients should be informed that excitability may occur, particularly in children, and marked drowsiness is a possible side effect. Alcoholic beverages should be avoided, as the combination of alcohol, sedatives, and tranquilizers can exacerbate drowsiness. Caution is advised when driving or operating machinery due to the potential for impaired alertness.

In cases of overdose, immediate medical attention is necessary. Patients should be instructed to contact a Poison Control Center (1-800-222-1222) without delay, as prompt intervention is critical for both adults and children, even in the absence of noticeable symptoms.

Patients should be advised to discontinue use and contact their healthcare provider if they experience nervousness, dizziness, or sleeplessness. Additionally, if pain, cough, or nasal congestion worsens or persists beyond seven days, or if redness or swelling occurs, medical consultation is warranted. New symptoms or a worsening fever lasting more than three days should also prompt a call to a healthcare professional. If a cough recurs or is accompanied by a rash or headache that persists, these may indicate a serious underlying condition requiring further evaluation.

Side Effects

Severe liver damage may occur in patients who exceed 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 these products.

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

Patients are advised to stop use and consult a doctor if they experience nervousness, dizziness, or sleeplessness during daytime use. Additionally, if pain, cough, or nasal congestion worsens or lasts more than seven days, or if redness or swelling is present, medical advice should be sought. New symptoms or a fever that worsens or lasts more than three days also warrant consultation. For nighttime use, similar precautions apply; worsening pain or cough lasting more than seven days, persistent fever, or the emergence of new symptoms should prompt a medical evaluation.

While using this product, patients may experience excitability, particularly in children, and marked drowsiness. It is recommended to avoid alcoholic beverages, as alcohol, sedatives, and tranquilizers may enhance drowsiness. Caution is advised when driving a motor vehicle or operating machinery due to the potential for increased drowsiness.

Drug Interactions

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

The use of this product is not recommended in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) for depression, psychiatric or emotional conditions, or Parkinson’s disease, and for a period of two weeks following the discontinuation of an MAOI. This combination may lead to serious adverse effects.

Patients taking the anticoagulant warfarin should consult a healthcare professional prior to using this product, as there may be an increased risk of bleeding.

Caution is advised when using this product in conjunction with alcohol, sedatives, or tranquilizers, as these substances may potentiate drowsiness and impair cognitive and motor functions. Monitoring for increased sedation is recommended in such cases.

Packaging & NDC

Below are the non-prescription pack sizes of Daytime Nighttime Cold Flu Relief (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 product, which includes both Daytime and Nighttime formulations. For patients aged 12 years and older, the recommended dosage for the Daytime product is 2 softgels taken with water every 4 hours, while the Nighttime product should be taken as 2 softgels with water every 6 hours.

Healthcare professionals should be aware that excitability may occur, particularly in children using this product. In the event of an overdose, it is critical to seek immediate medical attention 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. The potential risks and benefits must be carefully considered in these populations to ensure the safety of both the mother and the fetus or infant.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data on the excretion of this drug 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. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment should be aware that these products contain acetaminophen, which carries a risk of severe liver damage. It is critical that patients do not exceed 4,000 mg of acetaminophen in a 24-hour period, nor should they use these products in conjunction with other medications containing acetaminophen. Additionally, consumption of three or more alcoholic drinks daily while using these products may further increase the risk of liver damage.

Patients with a history of liver disease are advised to consult a healthcare professional prior to using these products. If symptoms such as pain, cough, or nasal congestion worsen or persist for more than seven days, patients should discontinue use and seek medical advice, as these symptoms may indicate a serious underlying condition.

In the event of an overdose, which can lead to liver damage, it is imperative to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222. Prompt medical attention is essential for both adults and children, even if no signs or symptoms of overdose are apparent.

Overdosage

Taking more than the recommended dose of this medication can lead to significant liver damage. 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.

Recommended Actions

Prompt medical attention is crucial for both adults and children, even if no signs or symptoms of overdose are apparent. Healthcare professionals should be vigilant in assessing the situation and providing appropriate interventions.

Potential Symptoms

While specific symptoms of overdose may not be detailed, the risk of liver damage underscores the importance of monitoring for any signs of hepatic impairment following an overdose.

Management Procedures

Upon recognition of an overdose, healthcare providers should initiate standard emergency protocols, which may include supportive care and monitoring of liver function. Early intervention can significantly improve outcomes in cases of overdose.

Nonclinical Toxicology

No teratogenic effects have been observed in nonclinical studies. Additionally, there are no reported non-teratogenic effects. The available data does not provide any details regarding nonclinical toxicology. Furthermore, there are no findings related to animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions associated with acetaminophen use: severe skin reactions, which include skin reddening, blisters, and rash. These events have been reported voluntarily or through surveillance programs.

Patient Counseling

Healthcare providers should advise patients about the importance of adhering to the recommended dosage, emphasizing that exceeding this dosage can lead to serious liver damage. In the event of an overdose, patients must seek immediate medical assistance 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 symptoms are apparent.

Patients should be informed that excitability may occur, particularly in children, and that marked drowsiness is a possible side effect. It is essential to counsel patients to avoid alcoholic beverages, as the combination of alcohol with this medication can enhance drowsiness. Additionally, patients should be cautioned that the use of sedatives and tranquilizers may further increase drowsiness.

Providers should remind patients to exercise caution when driving or operating machinery due to the potential for drowsiness. It is also important to encourage patients to consult with their healthcare provider before using this medication if they have any of the following conditions: liver disease, heart disease, diabetes, thyroid disease, high blood pressure, a cough that produces excessive phlegm, or difficulty urinating due to an enlarged prostate gland.

Furthermore, patients should be advised to seek guidance from a doctor or pharmacist prior to use if they are currently taking the blood-thinning medication warfarin or any sedatives or tranquilizers.

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 at a temperature range of 15-30°C (59-86°F) to maintain its efficacy. Care should be taken to avoid exposure to excessive heat, as this may compromise the integrity of the product. Proper storage conditions are crucial for ensuring the quality and safety of the product throughout its shelf life.

Additional Clinical Information

The medication is administered orally, with specific dosing guidelines for both daytime and nighttime use. For adults and children aged 12 years and older, the recommended daytime dosage is 2 softgels taken with water every 4 hours, not exceeding 4 doses within a 24-hour period. For nighttime use, the same population should take 2 softgels every 6 hours, also adhering to the maximum of 4 doses in 24 hours.

Clinicians should counsel patients to consult a health professional if they are pregnant or breastfeeding. It is crucial to keep the medication out of reach of children. An overdose warning is in place, as exceeding the recommended dosage may lead to liver damage. In the event of an overdose, immediate medical assistance should be sought, and contacting a Poison Control Center (1-800-222-1222) is advised, as prompt attention is essential for both adults and children, regardless of the presence of symptoms.

Drug Information (PDF)

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

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