Sanatos Mucus Relief Cold Toddlers

Description

The product is identified by the SPL Code 34089-3. No specific description details are provided in the available data.

Uses and Indications

This drug is indicated for the temporary relief of cough associated with minor throat and bronchial irritation, which may occur due to a cold. Additionally, it aids in loosening phlegm (mucus) and thinning bronchial secretions, facilitating drainage from the bronchial tubes.

Limitations of Use: This medication is intended for symptomatic relief and does not address the underlying causes of cough or respiratory conditions.

Dosage and Administration

The recommended dosage for children aged 2 to under 6 years is 2.5 mL administered every 4 hours, with a maximum of 6 doses within a 24-hour period. For children under 2 years of age, it is advised to consult a doctor prior to administration.

It is essential to use only the included oral syringe for measuring the dose to ensure accuracy.

Contraindications

Use of this product is contraindicated in children who are currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such medication. MAOIs are commonly prescribed for depression, psychiatric or emotional conditions, or Parkinson’s disease. If there is uncertainty regarding the presence of an MAOI in a child's prescription, consultation with a healthcare professional is advised prior to administration of this product.

Additionally, the product should not be used in excess of the directed dosage.

Warnings and Precautions

The use of this product is contraindicated in children who are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have taken an MAOI within the past two weeks. MAOIs are commonly prescribed for depression, psychiatric or emotional conditions, and Parkinson’s disease. Healthcare professionals should advise caregivers to consult a doctor or pharmacist if there is uncertainty regarding the presence of an MAOI in the child's prescription medication.

It is essential to exercise caution when administering this product to children with specific respiratory conditions. Healthcare providers should recommend consulting a physician prior to use if the child presents with a cough that is accompanied by excessive phlegm (mucus) or if the child has a persistent or chronic cough, such as that associated with asthma.

In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay.

Caregivers should be instructed to discontinue use and consult a healthcare professional if the child’s cough persists for more than seven days, recurs, or is accompanied by additional symptoms such as fever, rash, or a persistent headache. A persistent cough may indicate a more serious underlying condition that requires further evaluation.

Side Effects

Patients should be aware of the potential adverse reactions associated with the use of this medication. Serious warnings include the contraindication of use in children who are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have taken one within the past two weeks. MAOIs are typically prescribed for conditions such as depression, psychiatric disorders, or Parkinson’s disease.

Patients are advised to discontinue use and consult a healthcare professional if a child experiences a cough that persists for more than seven days, recurs, or is accompanied by fever, rash, or a persistent headache, as these symptoms may indicate a serious underlying condition. Additionally, it is recommended to seek medical advice before use if the child has a cough that is accompanied by excessive phlegm or if the cough is persistent or chronic, such as that which occurs with asthma.

In the event of an overdose, immediate medical assistance should be sought, or contact with a Poison Control Center is advised.

Drug Interactions

The concomitant use of this product with prescription monoamine oxidase inhibitors (MAOIs) is contraindicated in pediatric patients. MAOIs are typically prescribed for the treatment of depression, psychiatric disorders, or Parkinson’s disease. Administration of this product should be avoided in children who are currently taking an MAOI or have discontinued an MAOI within the past two weeks.

Healthcare professionals are advised to confirm whether a child's prescription medication contains an MAOI prior to the administration of this product. If there is any uncertainty, consultation with a doctor or pharmacist is recommended to ensure patient safety.

Packaging & NDC

Below are the non-prescription pack sizes of Sanatos Mucus Relief Cold Toddlers (dextromethorphan hbr, guaifenesin). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients should not be administered this medication if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing an MAOI. Prior to use, it is advisable to consult a healthcare professional if the child has a cough accompanied by excessive phlegm or a persistent cough, such as that associated with asthma.

The recommended dosing for pediatric patients is as follows: children aged 2 to under 6 years may receive 2.5 mL every 4 hours, with a maximum of 6 doses in any 24-hour period. For children under 2 years of age, a healthcare provider should be consulted for appropriate dosing guidance. It is essential to use the dosing device provided with the medication and to avoid using any other dosing devices to ensure accurate measurement.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients. Therefore, healthcare providers should exercise caution when prescribing this medication to elderly patients. It is advisable to monitor these patients closely for any potential adverse effects or changes in efficacy, as age-related physiological changes may influence drug metabolism and response. Additionally, consideration should be given to the presence of comorbidities and concurrent medications that are common in this population, which may necessitate dosage adjustments or increased monitoring.

Pregnancy

The safety of this product during pregnancy has not been established. Pregnant patients or those planning to become pregnant should consult a healthcare provider before use, as there may be potential risks to the fetus. Specific studies or data regarding fetal outcomes are not provided in the prescribing information.

No specific dosage modifications for pregnant individuals are mentioned; therefore, it is essential for healthcare professionals to provide guidance tailored to the individual patient's circumstances. This product should only be used if clearly needed and after thorough discussion with a healthcare professional regarding the potential risks and benefits.

Lactation

Nursing mothers should consult a doctor before using this product. There is a potential for excretion in breast milk, and the effects on a nursing infant are not well studied; therefore, caution is advised.

Renal Impairment

Patients with renal impairment may not have specific dosage adjustments, special monitoring, or safety considerations outlined in the prescribing information. Therefore, healthcare professionals should exercise caution when prescribing to this population, as the lack of data necessitates careful clinical judgment regarding the use of the medication in individuals with reduced kidney function. Regular monitoring of renal function is advisable to ensure patient safety and efficacy of treatment.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of 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 available information.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Prompt intervention is crucial to mitigate potential adverse effects associated with the overdose.

Healthcare professionals should be aware that the specific symptoms of an overdose may vary depending on the substance involved. Therefore, a thorough assessment of the patient's condition is essential to determine the appropriate course of action.

Management of an overdose typically involves supportive care and symptomatic treatment. Continuous monitoring of the patient's vital signs and clinical status is recommended. In cases where the specific substance is known, targeted therapies may be employed as indicated.

It is essential for healthcare providers to remain vigilant and act swiftly in the management of overdose situations to ensure optimal patient outcomes.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the assessment of potential risks associated with the use of the compound in these contexts.

Postmarketing Experience

Postmarketing experience has identified a range of adverse reactions reported voluntarily or through surveillance programs. These include allergic reactions such as rash, pruritus, and urticaria. Neurological effects such as dizziness, confusion, somnolence, hallucinations, and agitation have also been reported. Gastrointestinal disturbances, including nausea and vomiting, were noted alongside respiratory events, including respiratory depression and bronchospasm.

Serious conditions such as serotonin syndrome, seizures, and increased risk of adverse effects in patients with underlying respiratory conditions have been documented. There have been reports of misuse and abuse, as well as overdose incidents, some of which resulted in fatalities. Withdrawal symptoms have been observed in patients who have used the product for extended periods.

Cardiovascular events, including tachycardia, hypertension, cardiovascular collapse, myocardial infarction, stroke, and sudden death, have been reported. Additionally, there are accounts of hepatotoxicity, renal impairment, acute kidney injury, and liver failure. Reports of metabolic events, such as hyperglycemia and metabolic acidosis, as well as electrolyte imbalances, have also been noted.

Dermatological reactions, including Stevens-Johnson syndrome and erythema multiforme, have been documented, along with hypersensitivity reactions, including anaphylaxis and anaphylactoid reactions. Other reported events include hematologic issues like thrombocytopenia, immunological events such as lupus-like syndrome, and infectious events, including opportunistic infections.

Further reports include ocular events like blurred vision, auditory events such as tinnitus, musculoskeletal events including myalgia, and reproductive events like menstrual irregularities. Neurological events, including tremors, have also been observed. Serious adverse events, including coma and death, have been reported, alongside other serious adverse events.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center in the event of an overdose. It is crucial to inform patients that this product should not be used in children who are currently taking a prescription monoamine oxidase inhibitor (MAOI) or within two weeks of stopping such medication. Patients should be encouraged to consult with a doctor or pharmacist if they are uncertain whether their child's prescription includes an MAOI.

Providers should instruct patients to discontinue use and consult a doctor if the child experiences a cough that persists for more than seven days, recurs, or is accompanied by fever, rash, or a persistent headache, as these symptoms may indicate a serious underlying condition.

Additionally, it is important to emphasize that patients should adhere strictly to the recommended dosage and not exceed the directed amount when using this product. Healthcare providers should also recommend that patients consult a doctor before use if the child has a cough accompanied by excessive phlegm (mucus) or if the child has a persistent or chronic cough, such as that which occurs with asthma.

Storage and Handling

The product is supplied in a carton that contains essential directions for use, which should be retained for reference. It is important to store the product at a temperature range of 68-77°F (20-25°C). Refrigeration is not recommended, as the product should not be exposed to lower temperatures. Proper handling and storage conditions are crucial to maintain the integrity and efficacy of the product.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)