Basic Care Childrens Cough Dm

Description

Dextromethorphan Polistirex Extended-Release Oral Suspension is a cough suppressant formulated to provide 12 hours of cough relief. This preparation is presented as a grape-flavored liquid and is packaged in a 5 fluid ounce (148 mL) container, which includes a dosing cup for accurate administration. The formulation is alcohol-free and contains sodium metabisulfite, a sulfite that may elicit allergic-type reactions in susceptible individuals.

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. It also serves to relieve the impulse to cough, thereby assisting patients in achieving restful sleep.

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

Dosage and Administration

The bottle should be shaken well before each 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.

It is essential to follow these dosing instructions carefully to ensure safety and efficacy.

Contraindications

Use of this product is contraindicated in patients 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 2 weeks following the discontinuation of an MAOI due to the potential for serious interactions.

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

Warnings and Precautions

In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted at 1-800-222-1222.

This product is contraindicated for individuals currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications prescribed for depression, psychiatric or emotional conditions, or Parkinson’s disease. Additionally, it should not be used for a period of two weeks following the discontinuation of an MAOI. Healthcare professionals should advise patients to consult with a doctor or pharmacist if there is uncertainty regarding the presence of an MAOI in their prescription medications.

Patients should be aware of the Allergy Alert, as this product contains sodium metabisulfite, a sulfite that may trigger allergic-type reactions in susceptible individuals.

Patients are advised to discontinue use and consult a healthcare professional 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 a headache that lasts, it may indicate a serious condition, and medical advice should be sought promptly.

In summary, adherence to these warnings and precautions is essential for the safe use of this product.

Side Effects

Patients may experience various adverse reactions while using this medication. It is important to note that side effects can occur, and patients are encouraged to report any adverse reactions to the FDA at 1-800-FDA-1088.

Serious adverse reactions may include a persistent cough that lasts more than 7 days, or a cough that recurs or is accompanied by fever, rash, or headache. These symptoms could indicate a serious underlying condition that requires medical attention.

Common adverse reactions reported include chronic cough, particularly in patients with a history of smoking, asthma, or emphysema. Additionally, some patients may experience a cough associated with excessive phlegm (mucus).

Patients should be vigilant for these symptoms and consult healthcare professionals if they arise, especially if they indicate a potential serious condition.

Drug Interactions

The concomitant use of this product with prescription monoamine oxidase inhibitors (MAOIs) is contraindicated. MAOIs are typically prescribed for the treatment of depression, psychiatric or emotional conditions, and Parkinson’s disease. Patients should not take this product while on MAOIs or for a minimum of two weeks following the discontinuation of an MAOI.

It is essential for patients to consult with a healthcare professional, such as a doctor or pharmacist, to verify whether their current prescription medication contains an MAOI before initiating treatment with this product.

Packaging & NDC

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

Pediatric Use

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

Geriatric Use

There is no specific information 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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

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 lactation. Healthcare providers can offer guidance tailored to individual circumstances, ensuring the safety of both the patient and the developing fetus or nursing infant.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data on the excretion of this drug in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

Renal impairment may necessitate dosage adjustments for patients with reduced kidney function. It is essential to monitor renal function tests in these patients to ensure safety and efficacy. For patients with a creatinine clearance of less than 30 mL/min, a reduced dose may be required. Additionally, special monitoring is recommended for patients with significant renal impairment to manage potential risks effectively.

Hepatic Impairment

Use of the medication in patients with hepatic impairment requires caution. For patients with moderate to severe hepatic impairment, dosage adjustments may be necessary to ensure safety and efficacy. It is recommended that liver function tests be monitored periodically in patients with pre-existing liver disease to assess their liver function status. In cases of significant hepatic dysfunction, consideration should be given to reducing the dose to mitigate potential risks associated with impaired liver function.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should initiate supportive care, which may include monitoring vital signs, providing symptomatic treatment, and ensuring the patient's safety.

If available, consultation with a poison control center or a medical toxicologist is recommended to guide further management and treatment options.

Documentation of the incident, including the substance involved, the amount taken, and the time of ingestion, is crucial for effective management and follow-up care.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to use. The product contains sodium metabisulfite, which is a sulfite that may lead to allergic-type reactions in sensitive individuals. No additional specific information regarding nonclinical toxicology or animal pharmacology and toxicology is available.

Postmarketing Experience

Postmarketing experience has indicated that side effects may occur following the use of the product. Healthcare professionals and patients are encouraged to report any adverse events to the FDA at 1-800-FDA-1088. Reports received are considered voluntary and contribute to ongoing surveillance efforts.

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 this product should not be used concurrently with prescription monoamine oxidase inhibitors (MAOIs), which are medications prescribed for depression, psychiatric or emotional conditions, or Parkinson’s disease. Patients should also be cautioned against using this product for at least two weeks after discontinuing an MAOI. If patients are uncertain whether their prescription medication contains an MAOI, they should be encouraged to consult with their doctor or pharmacist.

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

Patients should be advised to stop using the product and seek medical advice if their cough persists for more than seven days, recurs, or is accompanied by fever, rash, or a headache that lasts, as these symptoms may indicate a serious condition. It is also important for healthcare providers to recommend that patients consult a doctor before using this product if they have a chronic cough associated with smoking, asthma, or emphysema, or 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 inform patients that the formulation contains sodium metabisulfite, which may trigger allergic-type reactions in susceptible individuals. Patients who are pregnant or breastfeeding are advised to consult a healthcare professional prior to use. In the event of an overdose, it is crucial to seek medical assistance or contact a Poison Control Center immediately at 1-800-222-1222.

Drug Information (PDF)

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

View product document (PDF)