Foster and Thrive 12 Hour Cough Relief

Description

Dextromethorphan Polistirex is the active ingredient in this formulation. It is presented as an Extended-Release Oral Suspension, which is an orange flavored liquid. The formulation includes sodium metabisulfite, a sulfite that may cause allergic-type reactions.

Uses and Indications

This drug is indicated for the temporary relief of cough due to minor throat and bronchial irritation, which may occur with the common cold or as a result of inhaled irritants. Additionally, it is indicated for the temporary relief of the impulse to cough, facilitating sleep.

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

Dosage and Administration

The bottle should be shaken well before use. Dosing must be measured exclusively with the dosing cup provided; the use of this cup with other products is not recommended.

For adults and children aged 12 years and older, the recommended dosage is 10 mL every 12 hours, with a maximum limit of 20 mL within a 24-hour period. For children aged 6 to under 12 years, the dosage is 5 mL every 12 hours, not to exceed 10 mL in a 24-hour period. For children aged 4 to under 6 years, the dosage is 2.5 mL every 12 hours, with a maximum of 5 mL in 24 hours. This product is not indicated for use in children under 4 years of age.

Healthcare professionals should ensure that patients adhere to these dosing guidelines or any alternative instructions provided by their physician.

Contraindications

Use of this product is contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing an MAOI. This includes certain medications prescribed for depression, psychiatric or emotional conditions, or Parkinson’s disease. Patients should consult a healthcare professional if uncertain whether their prescription contains an MAOI.

Additionally, this product contains sodium metabisulfite, which may cause allergic-type reactions in individuals with sulfite sensitivity.

Warnings and Precautions

Do not use this product if currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications for depression, psychiatric or emotional conditions, or Parkinson’s disease. Use is contraindicated for a period of 2 weeks following the discontinuation of an MAOI. If there is uncertainty regarding the presence of an MAOI in a prescription medication, it is imperative to consult a healthcare professional, such as a doctor or pharmacist, prior to use.

Allergy Alert: This product contains sodium metabisulfite, a sulfite that may provoke allergic-type reactions in susceptible individuals.

Before using this product, it is advisable to consult a healthcare provider if the patient has a chronic cough associated with smoking, asthma, or emphysema, or if the cough is accompanied by excessive phlegm (mucus).

Patients should discontinue use and seek medical advice if any side effects occur. Side effects can be reported to the FDA at 1-800-FDA-1088. Additionally, if a cough persists for more than 7 days, recurs, or is accompanied by fever, rash, or headache that lasts, these symptoms may indicate a serious underlying condition requiring medical evaluation.

In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center at 1-800-222-1222 without delay.

Side Effects

Patients should be aware of the potential adverse reactions associated with this product. Serious adverse reactions may occur, particularly in individuals currently taking a prescription monoamine oxidase inhibitor (MAOI) or within two weeks of discontinuing such medication. It is crucial for patients to consult a healthcare professional if they are uncertain whether their prescription includes an MAOI.

In addition, an allergy alert is warranted as the product contains sodium metabisulfite, which is a sulfite that may lead to allergic-type reactions in susceptible individuals.

Patients are advised to discontinue use and seek medical attention if side effects manifest. It is also recommended that patients report any side effects to the FDA at 1-800-FDA-1088. Furthermore, if a cough persists for more than seven days, recurs, or is accompanied by fever, rash, or headache that lasts, these symptoms may indicate a serious condition, and medical advice should be sought promptly.

Drug Interactions

The concomitant use of dextromethorphan with prescription monoamine oxidase inhibitors (MAOIs) is contraindicated. This combination may result in serious interactions, including the potential for hypertensive crises. It is advised that dextromethorphan not be administered to patients currently taking MAOIs or within two weeks following the discontinuation of MAOI therapy. Monitoring for adverse effects is recommended in patients who may have recently stopped MAOI treatment.

Packaging & NDC

Below are the non-prescription pack sizes of Foster and Thrive 12 Hour Cough Relief (dextromethorphan polistirex). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 12 years and older may be administered 10 mL every 12 hours, with a maximum dosage of 20 mL in a 24-hour period. For children aged 6 to under 12 years, the recommended dosage is 5 mL every 12 hours, not to exceed 10 mL in 24 hours. In children aged 4 to under 6 years, the dosage is 2.5 mL every 12 hours, with a maximum of 5 mL in 24 hours. The use of this medication is not recommended in children under 4 years of age.

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.

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 maternal health. Healthcare providers should consider the individual circumstances of each patient when making recommendations.

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 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 have not been specifically studied in relation to this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the prescribing information.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Healthcare professionals should advise patients or caregivers to call the Poison Control Center at 1-800-222-1222 for guidance.

Prompt intervention is crucial in managing overdose situations effectively. Symptoms of overdose may vary depending on the substance involved and the individual’s health status. Therefore, a thorough assessment and monitoring of the patient are essential to determine the appropriate course of action.

Management procedures may include supportive care and symptomatic treatment, tailored to the specific symptoms presented. It is vital for healthcare providers to remain vigilant and prepared to implement necessary interventions based on the clinical presentation of the patient.

Nonclinical Toxicology

If pregnant or breast-feeding, it is advised to consult a health professional before use. No non-teratogenic effects have been specified. Additionally, there are no details provided regarding nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified that side effects may occur with the use of the product. Healthcare professionals and patients are encouraged to report any adverse events to the FDA at 1-800-FDA-1088.

Additionally, it has been noted that a cough persisting for more than 7 days, a recurrent cough, or a cough accompanied by fever, rash, or headache may indicate the presence of a serious underlying condition.

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. It is crucial to inform patients that they should not use this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have stopped taking an MAOI within the past two weeks. Patients who are uncertain whether their prescription medication contains an MAOI should be encouraged to consult with their doctor or pharmacist prior to using this product.

Providers should also alert patients to the presence of sodium metabisulfite in the formulation, which may lead to allergic-type reactions in susceptible individuals. Patients should be instructed to discontinue use and consult a doctor if they experience any side effects. Additionally, they may report side effects to the FDA at 1-800-FDA-1088.

It is important for healthcare providers to advise patients to stop using the product and seek medical advice if their cough persists for more than seven days, returns, or is accompanied by fever, rash, or a headache that lasts, as these symptoms may indicate a serious condition. Patients with a chronic cough associated with smoking, asthma, or emphysema should be encouraged to consult a doctor before using the product. Furthermore, patients should be advised to seek medical guidance if their cough is accompanied by excessive phlegm (mucus).

Storage and Handling

The product is supplied in a bottle that requires careful handling and storage to maintain its efficacy. It should be stored at a temperature range of 20 °C to 25 °C (68 °F to 77 °F). Prior to use, the bottle must be shaken well to ensure proper mixing of the contents.

For accurate dosing, it is essential to measure the product only with the dosing cup provided. The dosing cup should not be used with any other products to prevent cross-contamination and ensure precise measurement.

Additional Clinical Information

Patients aged 12 years and older are advised to administer 10 mL every 12 hours, with a maximum of 20 mL in a 24-hour period. For children aged 6 to under 12 years, the recommended dosage is 5 mL every 12 hours, not exceeding 10 mL in 24 hours. Children aged 4 to under 6 years should receive 2.5 mL every 12 hours, with a maximum of 5 mL in 24 hours. The medication is not recommended for children under 4 years of age.

Clinicians should counsel patients to consult a doctor prior to use if they have a chronic cough associated with smoking, asthma, or emphysema, or if the cough is accompanied by excessive phlegm. Pregnant or breastfeeding patients should also seek advice from a healthcare professional before use. Patients are instructed to discontinue use and consult a doctor if side effects occur, with the option to report adverse effects to the FDA at 1-800-FDA-1088.

Drug Information (PDF)

This file contains official product information for Foster and Thrive 12 Hour Cough Relief, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)