Foster and Thrive Nighttime Cold and Flu Relief

Description

Foster & Thrive™ NIGHTTIME Cold & Flu Relief is a liquid formulation designed to alleviate symptoms associated with cold and flu. The active ingredients include acetaminophen, which serves as a pain reliever and fever reducer; dextromethorphan HBr, functioning as a cough suppressant; and doxylamine succinate, an antihistamine. This product is gluten-free and contains 10% alcohol. It is available in a cherry flavor and is packaged in a 12 fluid ounce (355 mL) bottle. The formulation is comparable to the active ingredients found in VICKS® NYQUIL® COLD & FLU.

Uses and Indications

This drug is indicated for the temporary relief of symptoms associated with the common cold and influenza. Specifically, it alleviates cough due to minor throat and bronchial irritation, sore throat, headache, minor aches and pains, fever, as well as runny nose and sneezing.

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

Dosage and Administration

Patients should adhere strictly to the prescribed dosage and administration guidelines. It is imperative to utilize only the dose cup provided with the medication to ensure accurate dosing.

For adults and children aged 12 years and older, the recommended dosage is 30 mL every 6 hours, with a maximum of 4 doses within a 24-hour period. For children aged 4 to under 12 years, it is advised to consult a healthcare professional for appropriate dosing recommendations. The medication is not indicated for use in children under 4 years of age.

Healthcare professionals should remind patients of the importance of not exceeding the maximum dosage to avoid potential 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 there is uncertainty regarding the presence of acetaminophen in other medications, consultation with a healthcare professional is advised.

• Concurrent use with prescription monoamine oxidase inhibitors (MAOIs) or within 2 weeks of discontinuing an MAOI, as this may lead to serious drug interactions. Patients should verify with a healthcare professional if their prescription medications include an MAOI.

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

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen, if the following conditions are met: exceeding 4,000 mg of acetaminophen within a 24-hour period, concurrent use with other medications containing acetaminophen, or consumption of three or more alcoholic drinks daily while using this product.

Acetaminophen may also lead to severe skin reactions, which can manifest as skin reddening, blisters, or rash. In the event of a skin reaction, it is imperative to discontinue use immediately and seek medical assistance.

Healthcare professionals should advise patients to consult a doctor prior to use if they have any of the following conditions: liver disease, glaucoma, a cough associated with excessive phlegm, breathing problems such as emphysema or chronic bronchitis, difficulty urinating due to an enlarged prostate gland, a persistent or chronic cough related to smoking, asthma, or emphysema, or if they are on a sodium-restricted diet. Additionally, patients should be cautioned to seek guidance from a doctor or pharmacist if they are taking sedatives, tranquilizers, or the anticoagulant warfarin.

In cases of overdose, immediate medical attention is crucial. Patients should be instructed to contact a Poison Control Center at 1-800-222-1222 or seek emergency medical help without delay, regardless of the presence of symptoms.

Patients should discontinue use and consult a doctor if any of the following occur: worsening pain or cough lasting more than 7 days, fever that worsens or persists beyond 3 days, presence of redness or swelling, emergence of new symptoms, or recurrence of cough accompanied by rash or headache lasting for an extended period. These symptoms may indicate a serious underlying condition that requires further evaluation.

Side Effects

Severe adverse reactions associated with the use of this product include the potential for severe liver damage, particularly if the daily dosage exceeds 4,000 mg of acetaminophen, if it is taken concurrently with other medications containing acetaminophen, or if the patient consumes three or more alcoholic drinks daily while using this product.

Patients may also experience severe skin reactions, which can manifest as skin reddening, blisters, or rash. In the event of a skin reaction, it is imperative that the patient discontinue use and seek immediate medical assistance. Additionally, if a sore throat is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, patients should consult a healthcare provider promptly.

Common adverse reactions may include excitability, particularly in children, and marked drowsiness. Patients are advised to avoid alcoholic beverages, as well as sedatives and tranquilizers, which may exacerbate drowsiness. Caution is recommended when driving or operating machinery due to the potential for impaired alertness.

Patients should discontinue use and consult a doctor if pain or cough worsens or lasts longer than seven days, if fever worsens or persists for more than three days, if redness or swelling occurs, if new symptoms arise, or if a cough recurs with a rash or headache that lasts, as these may indicate a serious condition.

It is advisable for patients to seek medical advice prior to using this product if they have a history of liver disease, glaucoma, excessive phlegm production, breathing problems such as emphysema or chronic bronchitis, urinary difficulties due to an enlarged prostate, persistent cough associated with smoking, asthma, or emphysema, or if they are on a sodium-restricted diet. Furthermore, patients should consult a healthcare professional if they are taking sedatives, tranquilizers, or the blood-thinning medication warfarin.

In the event of an overdose, immediate medical attention is critical. Patients or caregivers should contact a Poison Control Center or seek medical help right away, even if no signs or symptoms are apparent, as prompt intervention is essential for both adults and children.

Drug Interactions

Co-administration of this medication with any other product containing acetaminophen, whether prescription or nonprescription, is contraindicated due to the risk of acetaminophen overdose and associated hepatotoxicity.

Patients currently taking a prescription monoamine oxidase inhibitor (MAOI) for conditions such as depression, psychiatric disorders, or Parkinson’s disease should consult a healthcare professional prior to use. This includes individuals who have discontinued MAOI therapy within the past two weeks, as significant interactions may occur.

The concomitant use of sedatives or tranquilizers may potentiate drowsiness, necessitating caution in activities requiring alertness, such as driving or operating machinery.

Additionally, interactions may occur with the anticoagulant warfarin, which could affect coagulation parameters. Monitoring of INR (International Normalized Ratio) is advised to ensure therapeutic efficacy and safety when these agents are used together.

Packaging & NDC

Below are the non-prescription pack sizes of Foster and Thrive Nighttime Cold and Flu Relief (acetaminophen, dextromethorphan hbr, 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 not recommended for children under 4 years of age.

Caution is advised as excitability may occur, particularly in children. In the event of an overdose, prompt medical attention is essential for both adults and pediatric patients, even if no signs or symptoms are immediately 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 potential adverse effects or changes in therapeutic response, given the lack of detailed information on the use of this medication in the elderly population. Individualized assessment and clinical judgment are essential when determining the appropriateness of treatment in this demographic.

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 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 consult a healthcare professional prior to using this medication. It is essential for individuals with liver disease to receive appropriate guidance regarding the use of this product, as compromised liver function may affect the drug's metabolism and overall safety profile. Monitoring of liver function may be necessary to ensure the safe administration of the medication in this population.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222. Prompt intervention is essential for both adults and children, even in the absence of noticeable signs or symptoms.

Healthcare professionals should be aware that the lack of immediate symptoms does not preclude the potential for serious adverse effects. Therefore, vigilance and timely medical evaluation are crucial in managing overdose situations effectively.

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 specific information regarding nonclinical toxicology or animal pharmacology and toxicology is provided in the insert.

Postmarketing Experience

No specific postmarketing experience details are provided in the text.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 in the event of an overdose, as prompt 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 about the presence of acetaminophen in their medications, they should consult a doctor or pharmacist.

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 verify with their healthcare provider or pharmacist if they are unsure whether their prescription includes an MAOI.

Patients with a history of allergic reactions to this product or any of its ingredients should be advised against its use.

Healthcare providers should counsel patients 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 be instructed to seek medical advice if a cough recurs or is accompanied by a rash or headache that lasts, as these may indicate a serious condition.

When using this product, patients should be made aware that excitability may occur, particularly in children, and that marked drowsiness is a possible side effect. Patients should be cautioned to avoid alcoholic beverages while using this product, as well as to exercise caution when driving or operating machinery. The use of alcohol, sedatives, and tranquilizers may enhance drowsiness.

Patients should be advised to consult a doctor before using this product if they have liver disease, glaucoma, a cough associated with excessive phlegm, breathing problems such as emphysema or chronic bronchitis, difficulty urinating due to an enlarged prostate gland, a persistent or chronic cough related to smoking, asthma, or emphysema, or if they are on a sodium-restricted diet. Furthermore, patients should be encouraged to speak with a doctor or pharmacist before use if they are taking sedatives, tranquilizers, or the blood-thinning medication warfarin.

Storage and Handling

The product is supplied in a configuration that includes a dose cup, which must be used exclusively for administration. It is essential to store the product at a controlled room temperature of 20-25°C (68-77°F).

Once opened, the product should be discarded to ensure safety and efficacy. It is important to adhere to the dosing guidelines, which specify that no more than four doses should be taken within a 24-hour period.

Additional Clinical Information

The medication is administered orally, with a recommended dosage of 30 mL every 6 hours for adults and children aged 12 years and older. For children aged 4 to under 12 years, it is advised to consult a doctor regarding the appropriate dosage, while the medication is not recommended for children under 4 years of age.

Clinicians should counsel patients to take the medication only as directed, emphasizing the importance of adhering to the overdose warning. Patients are instructed to use only the provided dose cup and not to exceed 4 doses within a 24-hour period.

Drug Information (PDF)

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

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