Daytime Non Drows Cold and Flu and Nighttime Cold and

Description

This product is presented in a combination dosage form, specifically a Day Night 24 count combination pack. The effective date of this labeling is May 26, 2023. The principal display panel includes visual representations of the product, with images depicting both the front and back of the carton. The front image is labeled "Day Night 24 ct Cmdo," while the back image is simply labeled "Carton." The media type for both images is JPEG.

Uses and Indications

This drug is indicated for the temporary relief of symptoms associated with the common cold and influenza. Specifically, it alleviates fever, headache, minor aches and pains, cough due to minor throat and bronchial irritation, sore throat, and nasal congestion during daytime use. Additionally, it addresses runny nose and sneezing for nighttime relief.

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

Dosage and Administration

For daytime use, the recommended dosage for adults and children aged 12 years and older is to take 2 softgels with water every 4 hours, not to exceed 4 doses within a 24-hour period. For children aged 4 to under 12 years, it is advised to consult a physician before administration. The product is not intended for use in children under 4 years of age.

For nighttime use, adults and children aged 12 years and older should take 2 softgels with water every 6 hours, with a maximum of 4 doses in a 24-hour period. As with daytime dosing, parents or guardians should seek medical advice for children aged 4 to under 12 years, and the product should not be used in children under 4 years of age.

It is imperative to adhere strictly to the recommended dosages to avoid the risk of overdose.

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

• Use in children for the purpose of inducing sleep is contraindicated, as it is not intended for this use.

Additionally, it is advised not to exceed the recommended dosage and to avoid alcoholic beverages while using 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 recommended dosage, which should not exceed four doses within a 24-hour period. Caution is warranted when this product is taken in conjunction with other medications containing acetaminophen, as this may lead to unintentional overdose. Additionally, patients should be informed that consuming three or more alcoholic drinks daily while using this product significantly increases the risk of liver damage.

Acetaminophen may also provoke severe skin reactions. Symptoms indicative of such reactions include skin reddening, blisters, and rash. Should any of these symptoms manifest, patients must discontinue use immediately and seek medical assistance.

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

General precautions should be communicated to patients, including the importance of not exceeding the directed dosage. Marked drowsiness may occur, particularly when the product is taken at night. Patients should be cautioned against the consumption of alcoholic beverages during this time, as well as the use of sedatives and tranquilizers, which may exacerbate drowsiness. Special attention should be given to children, as excitability may occur. Patients should exercise caution when driving or operating machinery due to potential drowsiness.

In the event of an overdose, immediate medical attention is critical. Patients should be instructed to contact a Poison Control Center or seek emergency medical help without delay, even if no signs or symptoms are apparent.

Patients should discontinue use and contact their healthcare provider if they experience nervousness, dizziness, or sleeplessness during the day. Additionally, if pain, nasal congestion, or cough worsens or persists beyond seven days, or if fever worsens or lasts more than three days, medical consultation is necessary. Redness or swelling, the emergence of new symptoms, or a cough that recurs with a rash or headache that lasts should also prompt immediate medical evaluation, as these may indicate a serious condition.

Side Effects

Severe liver damage may occur in patients who exceed the maximum daily dosage of four doses within a 24-hour period, take the product in conjunction with other medications containing acetaminophen, 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 of severe sore throat that 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.

Patients should discontinue use and consult a doctor if they experience nervousness, dizziness, or sleeplessness during the daytime, or if pain, nasal congestion, or cough worsens or lasts more than seven days. For nighttime use, if pain or cough worsens or persists beyond seven days, or if fever worsens or lasts more than three days, medical advice should be sought. Additionally, the presence of redness or swelling, the emergence of new symptoms, or a cough that recurs with a rash or headache lasting longer than expected may indicate a serious condition requiring medical evaluation.

While using this product, patients may experience marked drowsiness, particularly with nighttime formulations. It is recommended to avoid alcoholic beverages, as well as sedatives and tranquilizers, which may enhance drowsiness. Patients should exercise caution when driving or operating machinery due to the potential for increased drowsiness and excitability, especially in children.

Drug Interactions

Co-administration of this medication with other products 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) or within 2 weeks of discontinuing an MAOI. This interaction may lead to severe hypertensive reactions.

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

Additionally, caution is advised for patients who are using sedatives or tranquilizers, particularly at nighttime. The concomitant use of alcohol, sedatives, and tranquilizers may enhance drowsiness, necessitating careful monitoring of sedation levels and potential impairment of motor skills.

Packaging & NDC

Below are the non-prescription pack sizes of Daytime Non Drows Cold and Flu and Nighttime Cold and (acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, 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 product is not recommended for children under 4 years of age. For adults and children aged 12 years and older, the recommended dosage is 2 softgels with water every 4 hours for daytime use or every 6 hours for nighttime use.

Healthcare professionals should be aware of the overdose warning: exceeding the recommended dosage can lead to serious health issues. In the event of an overdose, immediate medical assistance or contact with a Poison Control Center is essential, even if no symptoms are apparent.

Additionally, excitability may occur, particularly in children when used at nighttime.

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. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy, given the lack of targeted data for 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 associated with its use during pregnancy and lactation. The safety of this medication in pregnant women has not been established, and caution is advised to ensure the well-being of both the mother and the fetus.

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 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 individuals with reduced kidney function, as the absence of detailed guidance 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 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 four doses within a 24-hour period, as this represents the maximum daily amount for this product. Additionally, patients should avoid concomitant use with other medications containing acetaminophen and limit alcohol consumption to fewer than three alcoholic drinks per day while using this product.

Before initiating treatment, patients with known liver disease are advised to consult a healthcare professional. Monitoring of liver function may be warranted in these patients to ensure safety and efficacy during the course of therapy.

Overdosage

Overdose warning is a critical consideration for healthcare professionals when prescribing or advising on medication use. Taking more than the directed dosage can lead to serious health complications, necessitating immediate action.

In the event of an overdose, it is imperative to seek medical assistance or contact a Poison Control Center without delay. Quick medical attention is essential for both adults and children, even if no signs or symptoms are initially apparent. The potential for serious adverse effects underscores the importance of vigilance in monitoring dosage and recognizing the need for prompt intervention.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the assessment of potential risks associated with the use of the compound in these contexts.

Postmarketing Experience

Acetaminophen has been associated with severe skin reactions in postmarketing experience. Reports indicate that symptoms 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.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. 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 medication 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 have taken 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. Additionally, patients with a history of allergic reactions to this product or any of its ingredients should be cautioned against its use.

Patients should be made aware that this product is not intended to induce sleepiness in children and should not be used for that purpose. They should be instructed to stop using the product and consult a doctor if they experience nervousness, dizziness, or sleeplessness during the day. Furthermore, if pain, nasal congestion, or cough worsens or persists for more than seven days, patients should seek medical advice. Similar guidance applies to nighttime use, where patients should stop use and consult a doctor if pain or cough worsens or lasts beyond seven days, or if fever worsens or lasts more than three days. Patients should also be advised to seek medical attention if they notice redness or swelling, experience new symptoms, or if a cough returns with a rash or headache that persists, as these may indicate a serious condition.

When using this product, patients should be cautioned not to exceed the recommended dosage. They should be informed that marked drowsiness may occur, particularly with nighttime use, and should avoid alcoholic beverages during this time. Patients should also be made aware that excitability may occur, especially in children, and they should exercise caution when driving or operating machinery. The use of alcohol, sedatives, and tranquilizers may enhance drowsiness, and patients should be advised accordingly.

Patients should be encouraged to consult a doctor before using this product if they have a cough accompanied by excessive phlegm, liver disease, difficulty urinating due to an enlarged prostate, diabetes, heart disease, thyroid disease, high blood pressure, or a persistent or chronic cough associated with smoking, asthma, or emphysema. For nighttime use, patients should also seek medical advice if they have a breathing problem or chronic cough, or if they have glaucoma. Lastly, patients should be advised to consult a doctor or pharmacist if they are 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 assigned for identification. It is essential to store the product at room temperature to maintain its integrity and efficacy. No special handling requirements are noted; however, standard precautions should be observed to ensure optimal storage conditions.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. Additionally, it is important to keep the medication out of reach of children to ensure safety. No further information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

Drug Information (PDF)

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

View product document (PDF)