Childrens 12 Hr Cough Relief

Description

No description information is available for the specified drug.

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 dosing, the following guidelines should be adhered to, unless otherwise directed by a healthcare professional:

• Adults and children 12 years of age and over: Administer 10 mL every 12 hours, with a maximum dosage of 20 mL within a 24-hour period.

• Children 6 to under 12 years of age: Administer 5 mL every 12 hours, with a maximum dosage of 10 mL within a 24-hour period.

• Children 4 to under 6 years of age: Administer 2.5 mL every 12 hours, with a maximum dosage of 5 mL within a 24-hour period.

• Children under 4 years of age: The product is not recommended for use in this age group.

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. MAOIs are commonly prescribed for depression, psychiatric or emotional conditions, or Parkinson’s disease. Patients should consult a healthcare professional if uncertain about the presence of an MAOI in their prescription medication.

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

Warnings and Precautions

Patients should not use this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications for depression, psychiatric or emotional conditions, or Parkinson’s disease. Additionally, use is contraindicated for a period of two weeks following the discontinuation of an MAOI. If there is uncertainty regarding whether a prescription drug contains an MAOI, it is imperative to consult a healthcare professional, such as a doctor or pharmacist, prior to use.

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

General Precautions Before using this product, patients should seek medical advice if they have a chronic cough associated with smoking, asthma, or emphysema, or if they experience a cough accompanied by excessive phlegm (mucus).

Discontinuation of Use Patients are advised to stop using the product and contact their healthcare provider if any side effects occur. Side effects can be reported 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 may indicate a serious underlying condition requiring medical evaluation.

Emergency Medical Assistance In the event of an overdose, it is crucial to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222.

Side Effects

Patients may experience adverse reactions associated with the use of this medication. Notably, there is an Allergy Alert due to the presence of sodium metabisulfite, which is a sulfite that may lead to allergic-type reactions in susceptible individuals.

In clinical practice, patients are advised to discontinue use and consult a healthcare professional if any side effects occur. It is particularly important to seek medical advice if a cough persists for more than 7 days, recurs, or is accompanied by fever, rash, or headache lasting beyond a short duration, as these symptoms may indicate a serious underlying condition.

Patients are encouraged to report any side effects to the FDA at 1-800-FDA-1088 to contribute to ongoing safety monitoring.

Drug Interactions

Dextromethorphan is contraindicated for use in conjunction with monoamine oxidase inhibitors (MAOIs) or within 14 days of discontinuing an MAOI. The combination may lead to serious interactions, which can result in significant adverse effects. It is essential to avoid this combination to ensure patient safety. Monitoring for any signs of interaction is advised if there is a history of MAOI use within the specified timeframe.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 4 years of age should not use this product. For children aged 4 to under 6 years, the recommended dosage is 2.5 mL every 12 hours, with a maximum of 5 mL in a 24-hour period. In children aged 6 to under 12 years, the dosage increases to 5 mL every 12 hours, not to exceed 10 mL in 24 hours. For adolescents and adults aged 12 years and older, the dosage is 10 mL every 12 hours, with a maximum of 20 mL in 24 hours. The product is specifically labeled for use in children aged 4 years and older.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication. The prescribing information does not provide any recommended age considerations, dosage adjustments, safety concerns, or special precautions for geriatric patients. Therefore, healthcare providers should exercise clinical judgment when prescribing this medication to elderly patients, considering individual patient factors and potential risks associated with their overall health status. Monitoring for efficacy and safety is advised, as is the consideration of any comorbidities that may affect treatment outcomes 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 considered in these populations to ensure the safety of both the mother and the fetus or infant.

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

There is no specific information regarding renal impairment, dosage adjustments, special monitoring, or safety considerations for patients with reduced kidney function provided in the drug insert. Healthcare professionals should exercise caution when prescribing this medication to patients with renal impairment, as the lack of data may necessitate individualized assessment and monitoring based on the patient's overall clinical status.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this drug. Consequently, there are no 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. The national Poison Control Center can be reached at 1-800-222-1222.

Healthcare professionals should be aware that timely intervention is crucial in managing overdose situations. Symptoms of overdose may vary depending on the substance involved, and it is essential to monitor the patient closely for any signs of adverse reactions.

Management of an overdose typically involves supportive care and symptomatic treatment. Healthcare providers should ensure that the patient is stabilized and may need to implement specific protocols based on the substance taken. Continuous assessment and monitoring of vital signs are recommended to guide further treatment decisions.

In summary, prompt action and appropriate medical intervention are vital in the management of overdose cases to mitigate potential complications and ensure patient safety.

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 in the available data. Additionally, there are no detailed findings regarding nonclinical toxicology or animal pharmacology and toxicology provided in the current information.

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.

Patients should be informed of the Allergy Alert regarding the presence of sodium metabisulfite, which is a sulfite that may lead to allergic-type reactions in susceptible individuals.

It is important for healthcare providers to instruct patients to discontinue use and consult a doctor if any side effects occur. Patients may also report side effects to the FDA at 1-800-FDA-1088.

Healthcare providers should emphasize that patients must stop use and seek medical advice if a cough persists for more than 7 days, returns, or is accompanied by fever, rash, or a headache that lasts, as these symptoms may indicate a serious condition.

Patients should be encouraged to consult a doctor before using the product if they have a chronic cough associated with smoking, asthma, or emphysema. Additionally, patients should be advised to seek medical guidance if their cough is accompanied by excessive phlegm (mucus).

Storage and Handling

The product is supplied with a dosing cup included for accurate measurement. It should be stored at a temperature range of 20° to 25°C (68° to 77°F) to ensure optimal stability and efficacy. Proper storage conditions are essential for maintaining the integrity of the product.

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. It is important to keep the medication out of reach of children. In the event of an overdose, patients should seek medical assistance or contact a Poison Control Center immediately at 1-800-222-1222. No further information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

Drug Information (PDF)

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

View product document (PDF)