Daytime Nighttime Severe Cold and Flu Relief

Description

This combination pack contains a maximum strength formulation designed for daytime and nighttime relief of severe cold and flu symptoms. The daytime formulation includes acetaminophen, phenylephrine HCl, dextromethorphan HBr, and guaifenesin, providing multi-symptom relief as a pain reliever/fever reducer, nasal decongestant, cough suppressant, and expectorant. It is non-drowsy, alcohol-free, and antihistamine-free. The nighttime formulation contains doxylamine succinate and includes 10% alcohol. The total volume of the product is 12 FL OZ (355 mL).

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, sinus congestion and pressure, minor aches and pains, headache, fever, sore throat, runny nose, sneezing, and cough due to minor throat and bronchial irritation. Additionally, it aids in promoting sleep by addressing cough and reduces swelling of the nasal passages, thereby facilitating nasal and/or sinus drainage and restoring freer breathing through the nose.

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

Dosage and Administration

Patients should adhere strictly to the prescribed dosage and administration guidelines. It is imperative to utilize only the dose cup provided with the medication to ensure accurate dosing.

For adults and children aged 12 years and older, the recommended dosage is 30 mL every 4 hours, with a maximum of 4 doses within a 24-hour period. For children aged 4 to under 12 years, it is advised to consult a healthcare professional for appropriate dosing recommendations. The medication is not indicated for use in children under 4 years of age.

Healthcare professionals should emphasize the importance of not exceeding the maximum dosage to avoid potential overdose, as detailed in the Overdose warning.

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 there is uncertainty regarding the presence of acetaminophen in other medications, consultation with a healthcare professional is advised.

• Concurrent use with prescription monoamine oxidase inhibitors (MAOIs) or within 2 weeks of discontinuing an MAOI. This includes certain medications prescribed for depression, psychiatric or emotional conditions, or Parkinson’s disease, as the combination may lead to serious adverse effects. Verification of MAOI status should be conducted with a healthcare provider if there is any doubt.

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

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 minimize the risk of liver injury: do not exceed 4,000 mg of acetaminophen within a 24-hour period, avoid concurrent use with other medications containing acetaminophen, and limit alcohol consumption to fewer than three alcoholic drinks per day while using this product.

Patients should be informed of the potential for severe skin reactions associated with acetaminophen. Symptoms indicative of such reactions may include skin reddening, blisters, and rash. In the event of a skin reaction, patients must discontinue use immediately and seek medical assistance.

In cases of severe sore throat, particularly if it persists for more than two days or is accompanied by fever, headache, rash, nausea, or vomiting, patients should be advised to consult a healthcare provider promptly.

Emergency medical help should be sought in the event of an overdose. Patients or caregivers should contact a Poison Control Center (1-800-222-1222) immediately, as rapid medical intervention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

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

Side Effects

Severe adverse reactions associated with this product include significant liver damage, which may occur 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 this product.

Patients should be aware of the potential for 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 patients experience 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 professional promptly.

Common adverse reactions warranting medical consultation include nervousness, dizziness, or sleeplessness. Patients should also seek medical advice if pain, nasal congestion, or cough worsens or lasts longer than seven days, if fever intensifies or persists beyond three days, if redness or swelling occurs, if new symptoms arise, or if a cough recurs alongside a rash or headache that lasts. These symptoms may indicate a serious underlying condition.

Patients with pre-existing conditions such as liver disease, heart disease, high blood pressure, thyroid disease, diabetes, glaucoma, or breathing problems (including emphysema or chronic bronchitis) should consult a doctor before using this product. Furthermore, individuals experiencing persistent or chronic cough, particularly those related to smoking, asthma, or emphysema, or those on a sodium-restricted diet should also seek medical advice prior to use.

It is advisable for patients to consult a doctor or pharmacist if they are taking sedatives, tranquilizers, or the blood-thinning medication warfarin, as these may interact with the product.

Drug Interactions

Co-administration of this product with other medications 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 any other medication.

Caution is advised when this product is used concurrently with warfarin, a blood-thinning agent. Patients should seek guidance from a healthcare provider prior to use if they are currently taking warfarin.

The use of this 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 conditions, or Parkinson’s disease. Patients should confirm with a healthcare professional if they are unsure whether their prescription includes an MAOI.

Additionally, patients are advised to limit alcohol consumption to fewer than three drinks per day while using this product to avoid potential adverse effects.

No specific interactions with laboratory tests have been identified in the available data.

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 aged 4 to under 12 years should consult a healthcare professional before use. For children under 4 years, the product is contraindicated. The recommended dosage for adults and children aged 12 years and older is 30 mL every 4 hours. For children aged 6 to under 12 years, the dosage is 15 mL every 4 hours.

Caution is advised as excitability may occur, particularly in children. Marked drowsiness is also a potential side effect. 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 exhibit increased sensitivity to side effects when using this product. Caution is advised in this population, particularly for those with underlying conditions such as liver disease, heart disease, high blood pressure, thyroid disease, diabetes, or urinary difficulties due to an enlarged prostate gland.

While there are no specific dosage adjustments or safety concerns noted for elderly patients, it is recommended that healthcare providers consult with a doctor or pharmacist prior to use if the elderly patient is concurrently taking other medications. This is especially important for those using products containing acetaminophen or anticoagulants such as warfarin, as potential interactions may necessitate careful monitoring or adjustments in therapy.

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 drug in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

There is no specific information regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in this patient population.

Hepatic Impairment

Patients with hepatic impairment should be closely monitored due to the potential risk of severe liver damage associated with the use of this product, which contains acetaminophen. It is critical that patients do not exceed a maximum dosage of 4,000 mg of acetaminophen within a 24-hour period, as this threshold poses a significant risk for liver injury.

Additionally, patients with compromised liver function must be advised against the concurrent use of other medications containing acetaminophen, as this can further increase the risk of severe liver damage.

Patients should also be cautioned about the consumption of alcohol while using this product. Specifically, the intake of three or more alcoholic drinks per day may exacerbate the risk of liver damage.

Due to these considerations, it is recommended that healthcare providers assess liver function and consider dosage adjustments or alternative therapies for patients with hepatic impairment to mitigate the risk of adverse effects. Regular monitoring of liver function tests may be warranted in these patients to ensure safety and efficacy.

Overdosage

In cases of overdosage, it is critical to recognize the potential for severe liver damage associated with the use of this product, which contains acetaminophen.

Liver Damage Risk Healthcare professionals should be aware that taking more than 4,000 mg of acetaminophen within a 24-hour period significantly increases the risk of severe liver damage. Additionally, the concomitant use of this product with other medications that also contain acetaminophen can exacerbate this risk, leading to potentially life-threatening liver injury.

Alcohol Consumption The risk of liver damage is further heightened in individuals who consume three or more alcoholic drinks daily while using this product. It is essential for healthcare providers to counsel patients on the dangers of combining acetaminophen with alcohol, as this combination can lead to severe hepatic complications.

Recommended Actions In the event of suspected overdosage, immediate medical attention is warranted. Healthcare professionals should initiate appropriate management procedures, which may include monitoring liver function tests and considering the administration of N-acetylcysteine as an antidote, depending on the severity of the overdose and the time elapsed since ingestion. Prompt recognition and intervention are crucial to mitigate the risk of irreversible liver damage.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to use. Acetaminophen has been associated with 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.

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. Reported symptoms of these reactions 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, there is a warning regarding overdose. In cases of overdose, it is crucial to obtain medical help or contact a Poison Control Center promptly (1-800-222-1222), as timely medical attention is essential for both adults and children, even in the absence of noticeable signs or symptoms.

Patients are also advised to stop use and consult a healthcare professional if they experience any of the following: increased nervousness, dizziness, or sleeplessness; worsening pain, nasal congestion, or cough lasting more than 7 days; fever that worsens or persists beyond 3 days; presence of redness or swelling; occurrence of new symptoms; or a cough that recurs or is accompanied by a rash or headache lasting for an extended period. These symptoms may indicate a serious underlying condition.

Patient Counseling

Healthcare providers should advise patients about the importance of seeking immediate medical help or contacting a Poison Control Center (1-800-222-1222) in the event of an overdose, as prompt medical attention is critical for both adults and children, even if no signs or symptoms are apparent.

Patients should be instructed not to use this product in conjunction with any other medications containing 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 essential to inform patients that this product should not be used if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have stopped taking one within the past two weeks. Patients should be advised to check with their healthcare provider 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. Healthcare providers should instruct patients to discontinue use and consult a doctor if they experience nervousness, dizziness, or sleeplessness.

Patients should also be advised to stop using the product and seek medical advice if pain, nasal congestion, or cough worsens or persists for more than seven days, if fever worsens or lasts more than three days, or if any redness or swelling occurs. They should be informed to consult a doctor if new symptoms arise or if a cough returns or occurs with a rash or headache that lasts, as these may indicate a serious condition.

When using this product, patients should be reminded to adhere strictly to the recommended dosage. They should be made aware that excitability may occur, particularly in children, and that marked drowsiness is a possible side effect. Patients should be cautioned against consuming alcoholic beverages while using this product, as well as being careful when driving or operating machinery due to the potential for increased drowsiness, especially when combined with alcohol, sedatives, or tranquilizers.

Healthcare providers should encourage patients to consult a doctor before using this product if they have any of the following conditions: liver disease, heart disease, high blood pressure, thyroid disease, diabetes, glaucoma, a cough associated with excessive phlegm, breathing problems such as emphysema or chronic bronchitis, difficulty urinating due to an enlarged prostate gland, a persistent or chronic cough related to smoking, asthma, or emphysema, or if they are on a sodium-restricted diet. Additionally, patients should be advised to seek guidance from a doctor or pharmacist if they are taking sedatives, tranquilizers, or the blood-thinning medication warfarin.

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 controlled temperature range of 20-25°C (68-77°F) to maintain its integrity and efficacy. Proper storage conditions must be adhered to, ensuring that the product is kept within the specified temperature limits to prevent degradation.

Additional Clinical Information

Patients aged 12 years and older are advised to administer 30 mL every 4 hours, while those between 6 to under 12 years should take 15 mL every 4 hours. For children aged 4 to under 6 years, consultation with a healthcare provider is recommended, and the product is not indicated for children under 4 years of age.

Clinicians should counsel patients to consult a health professional if they are pregnant or breastfeeding. It is essential to keep the product 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 crucial for both adults and children, regardless of the presence of symptoms.

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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