Night Time Multi-Symptom 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 common cold and flu symptoms, including cough due to minor throat and bronchial irritation, sore throat, minor aches and pains, fever, runny nose, and sneezing.

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

Dosage and Administration

Patients should take the medication only as directed, adhering to the warning provided. The maximum allowable dosage is four doses within a 24-hour period.

For adults and children aged 12 years and older, the recommended dosage is two softgels taken with water every six hours. For children aged 4 to under 12 years, it is advised to consult a physician for appropriate dosing. The medication is not recommended for children under 4 years of age.

When utilizing other Daytime or Nighttime products, it is essential to read each label carefully to ensure correct dosing and avoid exceeding the 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.

• Concurrent use with a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing an MAOI, as this may lead to serious drug interactions.

• Administration to induce sleep in children is contraindicated, as it may pose safety risks.

Additionally, patients should avoid alcoholic beverages, as alcohol may enhance drowsiness when combined with this product. It is essential to keep this medication out of reach of children and to adhere strictly to the recommended dosage to prevent potential misuse or adverse effects.

Warnings and Precautions

This product contains acetaminophen, which carries specific warnings and precautions that healthcare professionals should be aware of to ensure safe use.

Liver Warning Severe liver damage may occur if the maximum daily dosage of 8 Liquid Caps is exceeded within a 24-hour period. Additionally, the risk of liver damage increases if this product is taken concurrently with other medications containing acetaminophen or if the patient consumes three or more alcoholic drinks daily while using this product.

Allergy Alert Acetaminophen may lead to severe skin reactions. Symptoms indicative of such reactions include skin reddening, blisters, and rash. In the event of a skin reaction, it is imperative to discontinue use immediately and seek medical assistance.

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

Emergency Medical Help In cases of accidental overdose, it is crucial to seek emergency medical help or contact a Poison Control Center immediately. Timely medical intervention is essential for both adults and children, even in the absence of noticeable signs or symptoms.

Discontinuation and Consultation Patients should stop taking this product and consult a healthcare provider if any of the following occur: pain or cough worsens or lasts longer than seven days; fever worsens or persists for more than three days; redness or swelling is observed; new symptoms develop; 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 medical evaluation.

Side Effects

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

Severe liver damage may occur with the use of this product, particularly if patients exceed the maximum daily dosage of 8 Liquid Caps within a 24-hour period, take other medications containing acetaminophen concurrently, 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. In the event of a skin reaction, patients are advised to discontinue use immediately and seek medical assistance.

Patients should also be cautious regarding sore throat symptoms. 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 that they consult a healthcare professional promptly.

Furthermore, patients are advised to stop use and consult a doctor if any of the following occur: pain or cough worsens or lasts longer than seven days; fever worsens or lasts longer than three days; redness or swelling is observed; new symptoms develop; or if a cough recurs or is accompanied by a rash or headache that persists. These symptoms may indicate a serious condition requiring medical evaluation.

Drug Interactions

There are currently no documented drug interactions associated with the use of this medication. Additionally, there is no information available regarding 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 Night Time Multi-Symptom Cold and Flu Relief (acetaminophen, dextromethorphan hydrobromide, doxylamine succinate). 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 contraindicated in children under 4 years of age. For adults and children aged 12 years and older, the recommended dosage is 2 softgels with water every 6 hours, with a maximum of 4 doses within a 24-hour period.

Caution is advised as excitability may occur, particularly in children.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any adverse effects or changes in therapeutic response, 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 considered in these populations to ensure maternal and fetal safety.

Lactation

Lactating mothers are advised to consult a healthcare professional prior to using this medication. There is currently no available data regarding the excretion of this medication 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 not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

Hepatic Impairment

Patients with hepatic impairment should be aware that this product contains acetaminophen, which carries a risk of severe liver damage. It is crucial for patients to adhere to the following guidelines to minimize the risk of hepatotoxicity.

The maximum recommended dosage for this product is 8 Liquid Caps in a 24-hour period. Patients with compromised liver function should not exceed this limit, as doing so may significantly increase the risk of severe liver damage. Additionally, patients should avoid concomitant use of other medications that contain acetaminophen, as this can further elevate the risk of hepatotoxicity.

Furthermore, patients are advised to limit alcohol consumption to fewer than 3 alcoholic drinks per day while using this product. The combination of acetaminophen and alcohol can exacerbate liver injury, particularly in individuals with pre-existing liver conditions.

Monitoring of liver function is recommended for patients with hepatic impairment who are prescribed this product. Regular assessment of liver enzymes may be warranted to ensure that liver function remains stable and to detect any potential adverse effects early.

Overdosage

In the absence of specific overdosage information, it is essential for healthcare professionals to remain vigilant and prepared for potential scenarios involving overdose.

Healthcare providers should be aware that the clinical presentation of an overdose may vary depending on the substance involved and the individual patient’s characteristics. Symptoms of overdose can range from mild to severe and may include altered mental status, cardiovascular instability, respiratory distress, and gastrointestinal disturbances.

In the event of suspected overdosage, immediate medical evaluation is recommended. Healthcare professionals should assess the patient's vital signs and conduct a thorough clinical examination. Supportive care should be initiated as necessary, including airway management, oxygen supplementation, and intravenous fluids.

If the specific agent involved in the overdose is known, appropriate antidotes or treatments should be administered as per established guidelines. Continuous monitoring of the patient’s condition is crucial, and further interventions may be required based on the severity of symptoms and the clinical judgment of the healthcare team.

It is advisable to consult local poison control centers or toxicology experts for guidance on management strategies tailored to the specific circumstances of the overdose.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions associated with the use of acetaminophen. Notably, severe skin reactions have been reported, which include symptoms such as skin reddening, blisters, and rash. In the event of a skin reaction, it is recommended that the use of acetaminophen be discontinued immediately, and medical assistance should be sought without delay.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. In the event of an accidental overdose, patients must seek medical help or contact a Poison Control Center immediately, as prompt medical attention is crucial for both adults and children, even if no signs or symptoms are apparent.

Patients should be informed not to use this medication in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription. If patients are uncertain whether a drug contains acetaminophen, they should consult a doctor or pharmacist for clarification.

It is essential to instruct patients not to use this medication if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have taken one within the past two weeks. Patients should be encouraged to ask their healthcare provider or pharmacist if they are unsure whether their prescription medication contains an MAOI.

Patients should be cautioned against using this medication to induce sleep in children. They should be advised to discontinue use and consult a doctor if pain or cough worsens or persists for more than 7 days, if fever worsens or lasts more than 3 days, if redness or swelling occurs, or if new symptoms develop. Additionally, patients should seek medical advice if a cough recurs or is accompanied by a rash or headache that lasts, as these may indicate a serious condition.

While using this product, patients must adhere strictly to the recommended dosage and avoid exceeding the directed amount. They should be made aware that excitability may occur, particularly in children, and that marked drowsiness is a possible side effect. Patients should be advised to avoid alcoholic beverages, as well as to exercise caution when driving or operating machinery, given the potential for increased drowsiness when combined with alcohol, sedatives, or tranquilizers.

Patients with liver disease, glaucoma, a cough associated with excessive phlegm, or breathing problems such as chronic cough, asthma, chronic bronchitis, or emphysema should consult a doctor before using this medication. Furthermore, patients experiencing difficulty urinating due to an enlarged prostate gland should also seek medical advice prior to use. Lastly, patients taking sedatives, tranquilizers, or the blood-thinning medication warfarin 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, maintaining a range of 20-25°C (68-77°F). Care should be taken to avoid exposure to excessive heat, as this may compromise the integrity of the product. Proper storage conditions are crucial to ensure the product remains effective and safe for use.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Night Time Multi-Symptom Cold and Flu Relief, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)