Daytime, Nighttime Severe Cold and Flu Relief

Description

No description information is available for the specified drug.

Uses and Indications

This drug is indicated for the temporary relief of symptoms associated with the common cold and influenza. Specifically, it alleviates minor aches and pains, nasal congestion, headache, fever, sore throat, sinus congestion and pressure, and cough. The formulation is designed for nighttime use to address cough due to minor throat and bronchial irritation, as well as runny nose and sneezing.

Additionally, this drug reduces swelling of the nasal passages, temporarily restores freer breathing through the nose, promotes nasal and/or sinus drainage, and helps loosen phlegm (mucus) and thin bronchial secretions, thereby facilitating more productive coughs during the daytime.

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

Dosage and Administration

Patients should adhere strictly to the recommended dosage and not exceed the maximum daily limit. For adults and children aged 12 years and older, the recommended dosage is 2 caplets taken with water every 4 hours, not to exceed 8 caplets within a 24-hour period. For children under 12 years of age, it is advised to consult a physician for appropriate dosing guidance.

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. If uncertain about the presence of acetaminophen in other medications, consult a healthcare professional.

• Concurrent use with prescription monoamine oxidase inhibitors (MAOIs) or within 2 weeks of discontinuing an MAOI, as this may lead to serious drug interactions. If there is uncertainty regarding the presence of an MAOI in a prescription medication, seek guidance from a healthcare professional.

• History of allergic reaction to this product or any of its ingredients, as this may result in severe allergic responses.

• Simultaneous use of DAYTIME and NIGHTTIME products is contraindicated to avoid potential adverse effects.

Warnings and Precautions

This product contains acetaminophen, which poses a risk of severe liver damage under certain conditions. Healthcare professionals should advise patients to avoid taking this product in conjunction with other medications containing acetaminophen, exceeding 4,000 mg of acetaminophen within a 24-hour period, or consuming three or more alcoholic drinks daily while using this product.

Acetaminophen may also trigger severe skin reactions, which can manifest as skin reddening, blisters, or rash. In the event of any skin reaction, patients must discontinue use immediately and seek medical assistance.

Patients experiencing a severe sore throat that persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, should be advised to consult a physician promptly.

General precautions should be taken for patients with specific medical conditions. Prior to use, patients should be instructed to consult a healthcare provider if they have liver disease, diabetes, high blood pressure, glaucoma (for nighttime use), thyroid disease, heart disease, a cough associated with excessive phlegm, or a persistent or chronic cough related to smoking, asthma, chronic bronchitis, or emphysema (for daytime use). Additionally, those with difficulty urinating due to prostate enlargement or chronic respiratory issues should seek medical advice before use.

Patients should also consult a doctor or pharmacist if they are currently taking warfarin, a blood-thinning medication, or sedatives and tranquilizers (for nighttime use).

In the event of an overdose, immediate medical attention is crucial. Patients should be instructed to contact a Poison Control Center or seek emergency medical help without delay, regardless of the presence of symptoms.

Patients must be advised to discontinue use 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 arise; or if a cough recurs with a rash or headache that lasts, as these may indicate a serious condition.

Side Effects

Severe liver damage may occur in patients taking this product if they use it in conjunction with other drugs containing acetaminophen, exceed 4,000 mg of acetaminophen within a 24-hour period, or 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, 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 cases where 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.

While using this product, it is crucial for patients to adhere to the recommended dosage. Notably, excitability may occur, particularly in children, as well as marked drowsiness, especially when taken at nighttime. Patients are also cautioned to avoid alcoholic beverages during this time, as alcohol, sedatives, and tranquilizers may exacerbate drowsiness. Care should be taken when driving a motor vehicle or operating machinery.

Patients should discontinue use and consult a doctor if they experience nervousness, dizziness, or sleeplessness. Additionally, if pain, nasal congestion, or cough worsens or persists for more than seven days, or if fever worsens or lasts more than three days, medical advice should be sought. Signs such as redness or swelling, the emergence of new symptoms, or a cough that recurs or is accompanied by a rash or headache lasting for an extended period may indicate a serious condition and warrant immediate medical evaluation.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there are no known interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Daytime, Nighttime Severe Cold and Flu Relief (acetaminophen, dextromethorphan hbr, doxylamine succinate, guaifenesin, phenylephrine hcl). 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 taken with water every 4 hours, with a maximum limit of 8 caplets from both Daytime and Nighttime products within a 24-hour period.

Caution is advised as excitability may occur, particularly in children when using the Nighttime formulation. Additionally, marked drowsiness is a potential side effect associated with the Nighttime product. It is essential to keep this medication out of reach of children to prevent accidental ingestion.

In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center without delay. Prompt medical attention is crucial for both adults and children, even if no signs or symptoms are initially apparent.

Geriatric Use

Elderly patients may not require specific dosage adjustments or face unique safety concerns based on the available data. However, it is essential for healthcare providers to exercise caution when prescribing this medication to geriatric patients, particularly those aged 65 and older.

Before initiating treatment, it is advisable to consult a physician if the elderly patient has any of the following conditions: liver disease, diabetes, high blood pressure, glaucoma (specifically when using the nighttime formulation), thyroid disease, heart disease, or difficulty urinating due to prostate gland enlargement. These conditions may influence the overall safety and efficacy of the treatment.

Marked drowsiness is a potential side effect, especially with the nighttime formulation, and elderly patients may be particularly susceptible to this effect. Additionally, the concurrent use of alcohol, sedatives, and tranquilizers can exacerbate drowsiness, necessitating careful monitoring and consideration of these interactions in geriatric patients who may have heightened sensitivity.

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 weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure safe use during pregnancy and lactation.

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 should consult a healthcare professional prior to use, particularly if they experience difficulty in urination due to enlargement of the prostate gland. It is essential to assess renal function and consider potential dosing adjustments or monitoring requirements based on the degree of impairment.

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 imperative that patients do not exceed a total daily dose of 4,000 mg of acetaminophen, as exceeding this limit may significantly increase the risk of hepatotoxicity. Additionally, patients should avoid concurrent use of other medications containing acetaminophen to prevent unintentional overdose.

Patients with a history of liver disease are advised to consult a healthcare professional prior to using this product. Furthermore, individuals who consume three or more alcoholic drinks daily should refrain from using this product, as alcohol can exacerbate the risk of liver damage associated with acetaminophen. Regular monitoring of liver function may be warranted in patients with compromised liver function 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 noticeable 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 needed.

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 in the available data. Additionally, there are no detailed findings regarding nonclinical toxicology or animal pharmacology and toxicology provided in the current information.

Postmarketing Experience

Postmarketing experience has identified that acetaminophen may be associated with severe skin reactions, which can manifest as skin reddening, blisters, or rash. In the event of a skin reaction, it is advised to discontinue use and seek medical assistance immediately.

Additionally, reports indicate that users should stop taking acetaminophen and consult a healthcare professional if they experience nervousness, dizziness, or sleeplessness. Other concerning symptoms include worsening pain, nasal congestion, or cough lasting more than 7 days, as well as fever that worsens or persists beyond 3 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 that lasts may also indicate a serious condition requiring medical evaluation.

Patient Counseling

Patients should be advised to seek immediate medical help or contact a Poison Control Center in the event of an overdose, as prompt medical attention is critical for both adults and children, even if no signs or symptoms are present.

It is important to inform patients that they should not take DAYTIME and NIGHTTIME products simultaneously. Additionally, they should be cautioned against using this product in conjunction with any other medication containing acetaminophen, whether prescription or nonprescription. If patients are uncertain whether a drug contains acetaminophen, they should consult a doctor or pharmacist.

Patients should not use this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have taken one within the past two weeks. If patients are unsure whether their prescription medication contains an MAOI, they should seek clarification from a healthcare professional.

Patients with a history of allergic reactions to this product or any of its ingredients should be advised against its use. They should also be instructed to stop using the product and consult a doctor if they experience nervousness, dizziness, or sleeplessness.

If patients notice that pain, nasal congestion, or cough worsens or persists for more than 7 days, they should discontinue use and seek medical advice. Similarly, if fever worsens or lasts more than 3 days, or if redness or swelling occurs, patients should stop using the product and consult a healthcare provider. New symptoms or a cough that returns or occurs with a rash or headache that lasts should also prompt patients to seek medical attention, as these may indicate a serious condition.

Patients must be reminded not to exceed the recommended dosage while using this product. They should be made aware that excitability may occur, particularly in children, and that marked drowsiness is a possibility with the Nighttime formulation. Patients should avoid alcoholic beverages while using the Nighttime product and exercise caution when driving or operating machinery, as alcohol, sedatives, and tranquilizers may enhance drowsiness.

Patients with liver disease, diabetes, high blood pressure, glaucoma (for the Nighttime product), thyroid disease, or heart disease should be advised to consult a doctor before using this product. Additionally, patients experiencing a cough with excessive phlegm or a persistent or chronic cough, such as that associated with smoking, asthma, chronic bronchitis, or emphysema, should seek medical advice before use of the Daytime formulation. Those with difficulty urinating due to prostate enlargement or breathing problems should also consult a healthcare professional before using the Nighttime product.

Finally, patients taking the blood-thinning medication warfarin or those on sedatives or tranquilizers (for the Nighttime product) should be encouraged to discuss their current medications with a doctor or pharmacist prior to use.

Storage and Handling

The product is supplied in a tamper-evident package. It should not be used if the outer package is opened or if the blister is torn or broken.

Storage conditions require the product to be maintained at a temperature of 25ºC (77ºF), with permissible excursions between 15ºC and 30ºC (59ºF to 86ºF). The expiration date and lot number can be found on the end flap of the packaging.

Additional Clinical Information

Patients should be informed that the medication is administered orally. For adults and children aged 12 years and older, the recommended dosage is 2 caplets taken with water every 4 hours, with a maximum limit of 8 caplets from both Daytime and Nighttime products within a 24-hour period.

Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. Additionally, resources regarding the potential for medicine abuse, particularly among teens, can be found at www.StopMedicineAbuse.org. No further information is available regarding laboratory tests or postmarketing experiences.

Drug Information (PDF)

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

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