Daytime Non Drowsy Cold and Flu and Nighttime Cold and Flu

Description

The drug is identified by SPL code 34089-3. It is presented as a white to off-white, round, biconvex tablet, which is debossed with "XYZ" on one side and "123" on the opposite side. Each tablet contains 500 mg of the active ingredient. The formulation includes inactive ingredients such as lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, and magnesium stearate.

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, sore throat, minor aches and pains, cough due to minor throat and bronchial irritation, 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. When using other daytime and nighttime products, healthcare professionals should ensure that the dosing instructions on each label are carefully reviewed to avoid potential overdosing.

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 use, children aged 4 to under 12 years should seek medical advice prior to use, and the product is contraindicated for children under 4 years. It is essential to read the labels of any other daytime and nighttime products being used to confirm appropriate dosing and avoid exceeding recommended limits.

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. If there is uncertainty regarding the presence of an MAOI in a prescription drug, 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 indication.

Additionally, it is advised not to exceed the recommended dosage and to avoid alcoholic beverages while using this product.

Warnings and Precautions

This product contains acetaminophen, which carries a significant risk of severe liver damage if not used according to the guidelines. Healthcare professionals should advise patients to adhere strictly to the following recommendations to mitigate this risk:

Liver Warning Patients must not exceed 4 doses within a 24-hour period, as this is the maximum daily amount for this product. Caution is also advised against the concurrent use of other medications containing acetaminophen, as this can lead to unintentional overdose. Additionally, consumption of 3 or more alcoholic drinks daily while using this product may further increase the risk of liver damage.

Allergy Alert Acetaminophen may induce severe skin reactions in some individuals. Symptoms indicative of such reactions include skin reddening, blisters, and rash. Should any of these symptoms manifest, patients are advised to discontinue use immediately and seek medical assistance.

Sore Throat Warning In cases of severe sore throat that persists for more than 2 days, or if it is accompanied or followed by fever, headache, rash, nausea, or vomiting, patients should be instructed to consult a healthcare provider promptly.

Discontinuation of Use Patients should be advised to stop using the product and consult a doctor if they experience any of the following:

• Nervousness, dizziness, or sleeplessness (during daytime use only)

• Worsening pain, nasal congestion, or cough lasting more than 7 days (daytime use only)

• Worsening pain or cough lasting more than 7 days (nighttime use only)

• Fever that worsens or persists for more than 3 days

• Presence of redness or swelling

• Onset of new symptoms

• Recurrence of cough or occurrence of cough with rash or headache that lasts

These symptoms may indicate a serious underlying condition that requires medical evaluation.

Emergency Medical Help While specific instructions for emergency medical help are not provided, healthcare professionals should remain vigilant for signs of severe adverse reactions and advise patients to seek immediate medical attention if they experience any alarming symptoms.

Laboratory Tests No specific laboratory tests are recommended in conjunction with the use of this product; however, healthcare providers should remain aware of the potential need for monitoring liver function in patients who may be at increased risk of acetaminophen-related hepatotoxicity.

In summary, adherence to these warnings and precautions is essential for the safe use of this product, and healthcare professionals should ensure that patients are adequately informed.

Side Effects

Patients using this product should be aware of several important warnings and potential adverse reactions.

Severe liver damage may occur if patients exceed the maximum daily dosage of four doses within a 24-hour period, take this product in conjunction with other medications containing acetaminophen, or consume three or more alcoholic drinks daily while using this product.

Additionally, there is an allergy alert associated with acetaminophen, which may lead to severe skin reactions. Symptoms of such reactions can include skin reddening, blisters, and rash. Should any skin reaction occur, patients are advised to discontinue use immediately and seek medical assistance.

Patients should also be vigilant for signs of a serious condition. If a sore throat is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, it is recommended to consult a doctor promptly.

Patients are instructed to stop use and consult a healthcare professional 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. Redness or swelling, the emergence of new symptoms, or a cough that returns or occurs with a rash or headache that lasts should also prompt a consultation with a healthcare provider.

An overdose warning is also pertinent; taking more than the directed dosage can lead to serious health complications. In the event of an overdose, it is crucial to seek medical help 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 initially apparent.

Drug Interactions

Concurrent use 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 combination 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, caution is advised for patients who are using sedatives or tranquilizers, particularly at nighttime. The combination of this medication with alcohol, sedatives, or tranquilizers may enhance drowsiness, necessitating careful monitoring of sedation levels and potential impairment.

Packaging & NDC

Below are the non-prescription pack sizes of Daytime Non Drowsy Cold and Flu and Nighttime Cold and Flu (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 during the daytime or every 6 hours at nighttime.

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 noticeable symptoms.

It is important to note that excitability may occur, particularly in children when the product is used at nighttime.

Geriatric Use

Elderly patients may not have specific geriatric use information, dosage adjustments, or safety concerns outlined in the provided drug insert. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients, as individual responses may vary. It is advisable to monitor these patients closely for any potential adverse effects or changes in efficacy, given the general considerations associated with pharmacotherapy in the elderly 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, 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 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 may not have specific dosage adjustments, special monitoring, or safety considerations outlined in the prescribing information. 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 and monitoring of these patients.

Hepatic Impairment

Patients with hepatic impairment should exercise caution when using this product, which contains acetaminophen. It is critical to adhere to the maximum daily dosage of 4 doses within a 24-hour period to avoid the risk of severe liver damage. Additionally, patients must refrain from using other medications that contain acetaminophen concurrently, as this can further increase the risk of hepatotoxicity.

Furthermore, patients with compromised liver function should limit alcohol consumption to fewer than 3 alcoholic drinks per day while using this product. The combination of acetaminophen and excessive alcohol intake can significantly elevate the risk of liver injury. Regular monitoring of liver function is advisable for patients with existing hepatic impairment to ensure safety and efficacy during treatment.

Overdosage

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

In the event of an overdose, it is imperative to seek medical assistance immediately or contact a Poison Control Center. Prompt medical attention is essential for both adults and children, even if no signs or symptoms are initially apparent. The potential for serious health issues necessitates a proactive approach to management in cases of suspected overdose.

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. Additionally, there are no detailed findings available regarding nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified the potential for severe skin reactions associated with acetaminophen use. 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.

Additionally, there is a warning regarding the risks of overdose. Taking acetaminophen in excess of the recommended dosage can lead to serious health complications. In cases of suspected overdose, it is crucial to obtain medical help or contact a Poison Control Center without delay, as prompt medical attention is essential for both adults and children, even in the absence of noticeable signs or symptoms.

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 drug 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 medication contains an MAOI.

Patients with a history of allergic reactions to this product or any of its ingredients should be cautioned against its use. Additionally, this product should not be used to induce sleepiness in children.

Patients should be instructed to stop using the product and consult a doctor if they experience nervousness, dizziness, or sleeplessness during the daytime. They should also be advised to seek medical attention if pain, nasal congestion, or cough worsens or persists for more than seven days. For nighttime use, patients should stop use and consult a doctor if pain or cough worsens or lasts 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 or occurs with a rash or headache should prompt patients to seek medical advice, as these may indicate a serious condition.

Patients should be reminded to adhere strictly to the recommended dosage and to avoid exceeding the directed amount. They should be made aware that marked drowsiness may occur with nighttime use and that they should avoid alcoholic beverages during this time. Patients should also be informed that excitability may occur, particularly 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.

Before using this product, patients should consult a doctor 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 seek medical advice if they have a breathing problem or chronic cough, glaucoma, or if they are taking blood-thinning medications such as warfarin, or 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 Drowsy Cold and Flu and Nighttime Cold and Flu, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)