Nighttime 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 sore throat, headache, minor aches and pains, fever, runny nose, sneezing, and cough due to minor throat and bronchial irritation.

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

Dosage and Administration

Patients should adhere strictly to the recommended dosage to avoid the risk of overdose. 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 as needed. It is imperative that the softgels are swallowed whole; they must not be crushed, chewed, or dissolved prior to ingestion.

This medication is not indicated for use in children under 12 years of age.

Contraindications

Use of this product is contraindicated in the following situations:

The product should not be used concurrently with any other medication 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.

Additionally, the product is contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such treatment. MAOIs are commonly prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. If there is uncertainty about the presence of an MAOI in a prescription medication, a healthcare professional should be consulted prior to use.

Patients are also advised not to exceed the recommended dosage and to avoid the consumption of alcoholic beverages while using this product.

Warnings and Precautions

This product contains acetaminophen, which carries a significant risk of severe liver damage under certain conditions. Healthcare professionals should advise patients to avoid exceeding 4,000 mg of acetaminophen within a 24-hour period. Additionally, patients should be cautioned against the concurrent use of other medications containing acetaminophen and the consumption of three or more alcoholic drinks daily while using this product.

Acetaminophen may also provoke severe skin reactions, which can manifest as skin reddening, blisters, or rash. In the event of any skin reaction, patients must discontinue use immediately and seek medical assistance.

Healthcare providers should be vigilant regarding patients presenting with a sore throat. If the sore throat is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, prompt consultation with a physician is warranted.

Patients should be instructed to stop using the product and consult a healthcare professional if any of the following occur: pain or cough worsens or lasts longer than seven days; fever worsens or persists beyond three days; redness or swelling develops; new symptoms arise; or if a cough recurs or is accompanied by a rash or headache that lasts. These symptoms may indicate a serious underlying condition.

In cases of suspected overdose, immediate medical attention is essential. Patients should be advised to contact a Poison Control Center (1-888-222-1222) without delay, as rapid intervention is critical for both adults and children, even in the absence of noticeable signs or symptoms.

Side Effects

Severe liver damage may occur in patients taking this product containing acetaminophen if they exceed 4,000 mg in 24 hours, 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 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. Additionally, if 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.

While using this product, excitability may occur, particularly in children, and marked drowsiness may be experienced. The use of alcohol, sedatives, or tranquilizers may exacerbate drowsiness, necessitating caution when driving or operating machinery.

Patients should discontinue use and consult a doctor if pain or cough worsens or persists beyond seven days, if fever worsens or lasts more than three days, if redness or swelling is observed, if new symptoms arise, or if a cough recurs with a rash or headache lasting. These symptoms could indicate a serious condition.

An overdose warning is also pertinent; taking more than the recommended dose can lead to liver damage. In the event of an overdose, it is crucial to seek medical help or contact a Poison Control Center (1-888-222-1222) immediately, as prompt medical attention is vital for both adults and children, even in the absence of noticeable signs or symptoms.

Drug Interactions

Co-administration of acetaminophen with warfarin may elevate the risk of bleeding. It is recommended that the International Normalized Ratio (INR) be monitored closely in patients receiving this combination to ensure safe therapeutic levels.

Additionally, the concurrent use of alcohol, sedatives, and tranquilizers with this product may potentiate drowsiness. Caution is advised when engaging in activities that require alertness, and dosage adjustments may be necessary based on the patient's response to these combinations.

Packaging & NDC

Below are the non-prescription pack sizes of Nighttime Cold and Flu Relief (acetaminophen, dextromethorphan hbr, doxylamine succinate). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should not use this medication. Caution is advised as excitability may occur, particularly in children. In the event of an overdose, it is crucial to seek immediate medical attention for both adults and children, even if no signs or symptoms are apparent.

Geriatric Use

Elderly patients may not have specific recommendations regarding age considerations, 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 potential for altered pharmacokinetics and pharmacodynamics in 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 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 mothers.

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. 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, which contains acetaminophen. Severe liver damage may occur if patients exceed 4,000 mg of acetaminophen in a 24-hour period, take other medications containing acetaminophen concurrently, or consume three or more alcoholic drinks daily while using this product.

It is advised that patients with liver disease consult a healthcare professional prior to use. During treatment, patients are strongly encouraged to avoid alcoholic beverages to minimize the risk of liver damage.

In the event of an overdose, which can lead to significant liver injury, immediate medical assistance should be sought. Patients should contact a Poison Control Center (1-888-222-1222) without delay, as prompt medical attention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Overdosage

Taking more than the recommended dose of the medication can lead to significant liver damage. In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center at 1-888-222-1222. Prompt medical intervention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Healthcare professionals should be aware that the severity of liver damage may not be immediately apparent, and therefore, vigilance is necessary. Monitoring and supportive care may be required, depending on the extent of the overdose and the patient's clinical presentation. It is essential to follow established protocols for managing overdoses, which may include activated charcoal administration if the patient presents within a suitable timeframe and is deemed appropriate.

In summary, any suspected overdose warrants urgent evaluation and management to mitigate potential hepatic complications.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to use.

Excitability may occur, particularly in children, and marked drowsiness has been observed. The concomitant use of alcohol, sedatives, and tranquilizers may enhance drowsiness.

No relevant information is available regarding carcinogenicity, mutagenicity, or impairment of fertility. Additionally, there is no pertinent data provided from animal pharmacology and toxicology studies.

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions: severe skin reactions, which may manifest as skin reddening, blisters, and rash. In the event of a skin reaction, it is advised to discontinue use and seek medical assistance promptly.

Patient Counseling

Healthcare providers should advise patients about the potential risks associated with overdose, emphasizing that taking more than the recommended dose can lead to liver damage. In the event of an overdose, patients should seek medical help or contact a Poison Control Center (1-888-222-1222) immediately, as prompt medical attention is crucial for both adults and children, even if no symptoms are apparent.

Patients should be informed 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 consult a doctor or pharmacist for clarification.

It is important to instruct patients not to use this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have stopped taking one within the last 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 advised to discontinue use and consult a doctor if their pain or cough worsens or persists for more than 7 days, if their fever worsens or lasts more than 3 days, or if they notice any redness or swelling. They should also be instructed to seek medical advice if new symptoms arise or if a cough returns or occurs alongside a rash or headache that lasts, as these may indicate a serious condition.

While using this product, patients should be cautioned against exceeding 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 avoid consuming alcoholic beverages while using this product, as alcohol, sedatives, and tranquilizers can enhance drowsiness.

Patients should be advised to exercise caution when driving or operating machinery due to the potential for drowsiness. Additionally, healthcare providers should recommend that patients consult a doctor before using this product if they have liver disease, glaucoma, difficulty urinating due to an enlarged prostate gland, or any breathing problems or chronic coughs associated with smoking, asthma, chronic bronchitis, or emphysema. Patients with a cough that produces excessive phlegm should also seek medical advice prior to use.

Finally, patients should be encouraged to consult a doctor or pharmacist if they are taking the blood-thinning medication warfarin or if they are using sedatives or tranquilizers, to ensure safe use of 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 a temperature range of 15-30ºC (59-86ºF) to maintain its efficacy. Care should be taken to avoid exposure to excessive heat, which may compromise the integrity of the product. Proper storage conditions are crucial for ensuring the quality and safety of the product throughout its shelf life.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)