Daytime Non Drows Cold and Flu and Nighttime Cold and

Description

No relevant information is available for SPL code 34089-3.

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 consult a physician for children aged 4 to under 12 years, and the product is contraindicated for 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 interactions. Verify the presence of MAOIs in prescription medications with a healthcare provider if unsure.

• 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 indication.

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 is a maximum of 4 doses within a 24-hour period. Patients should be cautioned against the concurrent use of other medications containing acetaminophen, as well as the consumption of three or more alcoholic drinks daily while using this product.

Acetaminophen has been associated with severe skin reactions. Symptoms indicative of such reactions may include skin reddening, blisters, and rash. In the event of any skin reaction, patients must be instructed to discontinue use immediately and seek medical assistance.

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

In the event of an overdose, it is imperative to seek emergency medical help or contact a Poison Control Center without delay. Quick medical attention is crucial for both adults and children, even if no signs or symptoms are immediately apparent.

Patients should be instructed to stop use and consult a healthcare professional if they experience any of the following: nervousness, dizziness, or sleeplessness (during the daytime); worsening pain, nasal congestion, or cough lasting more than seven days (daytime use); worsening pain or cough lasting more than seven days (nighttime use); fever that worsens or persists for more than three days; presence of redness or swelling; occurrence of new symptoms; or if a cough recurs or is accompanied by a rash or headache that lasts. These symptoms may indicate a serious underlying condition that requires further evaluation.

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 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.

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 symptoms, 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 that lasts warrants immediate medical consultation, as these may indicate a serious condition.

An overdose of this product can lead to serious health complications. Patients are urged to seek medical help or contact a Poison Control Center without delay in the event of an overdose, even if no signs or symptoms are immediately apparent. Quick medical attention is critical for both adults and 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.

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 serious adverse effects.

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

Additionally, individuals using sedatives or tranquilizers, particularly at nighttime, should seek advice from a healthcare provider before use. The combination of alcohol, sedatives, and tranquilizers with this medication may enhance drowsiness, necessitating caution in activities requiring alertness.

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.

Caution is advised regarding potential overdose, as taking more than the directed dosage can lead to serious health issues. In the event of an overdose, immediate medical assistance should be sought, or a Poison Control Center should be contacted, as prompt attention is crucial for both adults and children, even in the absence of symptoms.

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

Geriatric Use

There is no specific information available 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. 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 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.

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 in instances where no signs or symptoms are immediately apparent. The potential for serious health issues underscores the importance of vigilance and prompt intervention in overdose situations.

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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

No specific postmarketing experience details are provided in the insert text.

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 about the presence of acetaminophen in their other medications, 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 only be used as directed. They should be instructed to stop using the product and consult a doctor if they experience nervousness, dizziness, or sleeplessness during the day. Furthermore, patients should be advised to seek medical attention if pain, nasal congestion, or cough worsens or persists for more than seven days, or if fever worsens or lasts more than three days. Any signs of redness or swelling, new symptoms, or a cough that returns with a rash or headache should prompt a consultation with a healthcare provider, as these may indicate a serious condition.

When using this product, patients should be cautioned against exceeding the recommended dosage. They should be informed that marked drowsiness may occur, particularly at night, 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 with breathing problems or chronic coughs, as well as those with glaucoma, should also seek medical advice prior to use. Lastly, patients taking the blood-thinning medication warfarin or any sedatives or tranquilizers should consult a doctor or pharmacist before using this product.

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 room temperature to maintain its integrity and efficacy. No special handling requirements are noted, ensuring straightforward management within standard 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.

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