Daytime Nighttime Cold and Flu Relief

Description

This formulation contains a combination of active ingredients designed to provide relief from various symptoms associated with colds and allergies. The active components include acetaminophen, a pain reliever and fever reducer; dextromethorphan HBr, a cough suppressant; phenylephrine HCl, a nasal decongestant; and doxylamine succinate, an antihistamine.

The product is available in softgel and liquid-filled capsule dosage forms. It is specifically formulated to relieve aches, fever, sore throat, cough, sneezing, and runny nose. The formulation is non-drowsy, alcohol-free, and does not contain antihistamines.

Uses and Indications

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

Daytime Use: It provides relief from cough due to minor throat and bronchial irritation, nasal congestion, headache, minor aches and pains, fever, and sore throat.

Nighttime Use: It alleviates similar symptoms, including 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 use of this 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 the total does not exceed 4 doses 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 contraindicated for children under 12 years.

Healthcare professionals should advise patients to adhere strictly to the recommended dosages to avoid the risk of overdose.

Contraindications

Use of this product is contraindicated in the following situations:

The product should not be used concurrently with any other medication containing acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in a medication, consultation with a healthcare professional is advised.

Additionally, the product is contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such treatment. MAOIs are typically prescribed for depression, psychiatric or emotional conditions, or Parkinson’s disease. If there is any doubt about the presence of an MAOI in a prescription, a healthcare professional should be consulted prior to use.

Patients are also advised not to exceed the recommended dosage and to avoid the consumption of alcoholic beverages while using this product.

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, concomitant use with other medications containing acetaminophen, or consumption of three or more alcoholic beverages daily while using this product.

Acetaminophen may also lead to 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 be vigilant regarding sore throat symptoms. If a sore throat is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, prompt consultation with a physician is advised.

Overdose of acetaminophen can result in significant liver damage. In cases of suspected overdose, immediate medical attention is essential. Patients should be instructed to contact a Poison Control Center without delay, as rapid intervention is critical for both adults and children, even in the absence of overt symptoms.

Patients should be advised to discontinue use and consult a healthcare provider if any of the following occur: nervousness, dizziness, or sleeplessness; worsening or persistent pain, cough, or nasal congestion lasting more than seven days; fever that worsens or lasts more than three days; presence of redness or swelling; emergence of new symptoms; or recurrence of cough accompanied by rash or headache lasting longer than expected. These symptoms may indicate a serious underlying condition.

In summary, careful monitoring and adherence to dosing guidelines are essential to mitigate risks associated with acetaminophen use.

Side Effects

Severe adverse reactions associated with the use of products containing acetaminophen include the potential for severe liver damage. This risk is heightened if patients 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 the product.

Patients should be aware of the possibility of severe skin reactions, 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. Additionally, if a sore throat is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, patients are advised to consult a healthcare professional promptly.

Common adverse reactions that warrant discontinuation of use and consultation with a doctor include nervousness, dizziness, or sleeplessness, particularly during daytime use. Patients should also seek medical advice if pain, cough, or nasal congestion worsens or lasts longer than seven days, if fever intensifies or persists beyond three days, or if new symptoms arise. Redness or swelling should also prompt medical consultation, as these may indicate a serious condition.

During nighttime use, patients should be cautious of worsening pain or cough lasting more than seven days, persistent fever, or the emergence of new symptoms. The recurrence of cough, especially when accompanied by rash or headache, should also be evaluated by a healthcare provider.

When using these products, it is crucial for patients to adhere to the recommended dosage to avoid overdose, which can lead to liver damage. In cases of overdose, immediate medical attention is essential, and patients should contact a Poison Control Center without delay, as timely intervention is critical for both adults and children.

Additional considerations include the potential for excitability, particularly in children, and the risk of marked drowsiness. Patients are advised to avoid alcoholic beverages, as well as sedatives and tranquilizers, which may exacerbate drowsiness. Caution is recommended when driving or operating machinery due to these effects.

Drug Interactions

The concurrent use of DAYTIME and NIGHTTIME with other medications containing acetaminophen, whether prescription or nonprescription, is contraindicated due to the risk of acetaminophen overdose.

Additionally, the use of DAYTIME and NIGHTTIME is not recommended in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within two weeks of discontinuing such treatment. MAOIs are typically prescribed for depression, psychiatric or emotional conditions, or Parkinson’s disease, and their interaction with these products may lead to serious adverse effects.

Patients taking warfarin, a blood-thinning medication, should consult a healthcare professional before using either DAYTIME or NIGHTTIME, as there may be an increased risk of bleeding.

Furthermore, the use of NIGHTTIME in conjunction with alcohol, sedatives, or tranquilizers may enhance drowsiness. Caution is advised, and patients should be monitored for increased sedation and potential impairment of motor skills.

Packaging & NDC

Below are the non-prescription pack sizes of Daytime Nighttime Cold and 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 medication. For adolescents aged 12 years and older, the recommended dosage is 2 softgels taken with water every 4 hours for Daytime use and every 6 hours for Nighttime use.

Healthcare professionals should be aware that excitability may occur, particularly in children. In the event of an overdose, prompt medical attention is essential for both adults and children, even if no signs or symptoms are immediately apparent.

Geriatric Use

Elderly patients may not require specific dosage adjustments or exhibit unique safety concerns based on the available data. However, it is essential for healthcare providers to consider general precautions when prescribing this medication to geriatric patients.

Before initiating treatment, healthcare providers should advise elderly patients to consult with their physician if they have a history of liver disease, heart disease, diabetes, thyroid disease, high blood pressure, or urinary difficulties due to an enlarged prostate gland, particularly for daytime use. For nighttime use, it is also important to inquire about any history of liver disease, glaucoma, or chronic respiratory issues, including persistent cough.

Caution is warranted when this product is used in conjunction with anticoagulants such as warfarin, as well as with sedatives or tranquilizers, due to the potential for increased sedation. Marked drowsiness may occur, and the concomitant use of alcohol, sedatives, or tranquilizers can exacerbate this effect. Therefore, elderly patients should be advised to exercise caution when driving or operating machinery to mitigate the risk of accidents or injuries. Regular monitoring and assessment of the patient's response to treatment are recommended to ensure safety and efficacy.

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 regarding 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 not been specifically addressed in the drug insert regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of data necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients, although specific recommendations are not provided.

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 recommended dosage, which is limited to a maximum of 4,000 mg of acetaminophen in a 24-hour period. Additionally, patients should avoid the concurrent use of other medications containing acetaminophen and limit alcohol consumption to fewer than three alcoholic drinks per day while using this product.

Patients with known liver disease are advised to consult a healthcare professional prior to use. In the event of an overdose, which can lead to liver damage, immediate medical attention is essential. Patients should seek help or contact a Poison Control Center without delay, as prompt intervention is crucial for both adults and children, even in the absence of noticeable signs or symptoms. Monitoring of liver function may be warranted in patients with compromised liver function to ensure safety and efficacy during treatment.

Overdosage

Taking more than the recommended dose of the medication can lead to significant liver damage. In the event of an overdose, it is imperative to seek medical assistance immediately or contact a Poison Control Center. Prompt medical intervention is crucial for both adults and children, even in the absence of noticeable signs or symptoms of overdose.

Healthcare professionals should be vigilant in monitoring patients for any potential symptoms of overdose, which may not always be immediately apparent. The importance of rapid response cannot be overstated, as timely management can mitigate the risk of severe complications associated with liver injury.

Nonclinical Toxicology

If pregnant or breast-feeding, 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 associated with the use of acetaminophen. Notably, severe skin reactions have been reported, including 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

Patients should be advised not to exceed the recommended dosage, as taking more than the prescribed amount can lead to liver damage. In the event of an overdose, it is crucial to seek medical assistance 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 present.

Healthcare providers should inform patients that excitability may occur, particularly in children. Patients should also be cautioned against consuming alcoholic beverages, as alcohol can exacerbate drowsiness. Marked drowsiness is a potential side effect, and the use of alcohol, sedatives, and tranquilizers may further increase this drowsiness.

Patients should be reminded to exercise caution when driving a motor vehicle or operating machinery due to the risk of impaired alertness.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It should be stored at a temperature range of 15-30°C (59-86°F) to maintain its integrity and efficacy. Care should be taken to avoid exposure to excessive heat, which may compromise the product's quality. Proper storage conditions are essential to ensure optimal performance and safety.

Additional Clinical Information

Patients aged 12 years and older are advised to take 2 softgels with water every 4 hours for the Daytime formulation and every 6 hours for the Nighttime formulation. It is essential for patients to carefully read the labeling of both products to ensure correct dosing. Clinicians should counsel patients to consult a health professional if they are pregnant or breastfeeding before using these products.

No additional information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

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

View product document (PDF)