Signature Care Childrens Multi Symptom Cold

Description

This formulation contains Guaifenesin 100 mg, an expectorant, which aids in the clearance of mucus from the airways. It also includes Dextromethorphan HBr 5 mg, a cough suppressant that helps reduce the urge to cough. Additionally, the formulation contains Phenylephrine HCl 2.5 mg, a nasal decongestant that alleviates nasal congestion. The product is presented as a very berry flavored liquid, with a total volume of 4 fluid ounces (118 mL).

Uses and Indications

This drug is indicated for the relief of cough and nasal congestion associated with minor throat and bronchial irritation, which may occur due to the common cold or inhaled irritants. It helps to loosen phlegm (mucus) and thin bronchial secretions, facilitating the expulsion of bothersome mucus and making coughs more productive.

The drug temporarily relieves the intensity of coughing and the impulse to cough, aiding in sleep for children experiencing these symptoms. Additionally, it alleviates nasal congestion and a stuffy nose associated with colds.

Limitations of use include the absence of teratogenic or nonteratogenic effects, as no such information is provided.

Dosage and Administration

The maximum recommended dosage is 6 doses within a 24-hour period. Dosing should be measured exclusively with the dosing cup provided with the product; the use of this dosing cup with other products is not advised.

For children aged 6 years to under 12 years, the recommended dose is 10 mL every 4 hours. For children aged 4 years to under 6 years, the appropriate dose is 5 mL every 4 hours. It is important to note that this product is not recommended for use in children under 4 years of age.

Healthcare professionals should ensure that dosing instructions are followed precisely, and any deviations should be discussed with a physician.

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, and 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

It is imperative to adhere to the following warnings and precautions when considering the use of this product in pediatric patients.

Warnings This product must not be administered to children who are 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 2 weeks following the cessation of an MAOI. If there is uncertainty regarding whether a child’s prescription includes an MAOI, it is essential to consult a healthcare professional, such as a doctor or pharmacist, prior to administration.

General Precautions Prior to use, it is advisable to consult a healthcare provider if the child has any of the following conditions:

• Heart disease

• High blood pressure

• Thyroid disease

• Diabetes

• A cough that produces excessive phlegm (mucus)

• A persistent or chronic cough, such as that associated with asthma

Emergency Medical Help Instructions 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.

Stop Taking and Call Your Doctor Instructions The use of this product should be discontinued and a healthcare provider should be contacted if the child experiences any of the following:

• Nervousness, dizziness, or sleeplessness

• Symptoms that do not improve within 7 days or are accompanied by fever

• A cough that persists for more than 7 days, recurs, or is associated with fever, rash, or a persistent headache, as these may indicate a serious underlying condition.

Side Effects

Patients should be aware of the potential adverse reactions associated with the use of this medication. Serious adverse reactions may occur, particularly in children who are concurrently taking prescription monoamine oxidase inhibitors (MAOIs) or have taken them within the past two weeks. It is crucial to avoid the use of this medication in such cases due to the risk of significant interactions.

Common adverse reactions reported include nervousness, dizziness, and sleeplessness. If a child experiences any of these symptoms, it is advised to discontinue use and consult a healthcare professional. Additionally, if symptoms do not improve within 7 days, or if they are accompanied by fever, it is important to seek medical advice. A cough that persists for more than 7 days, recurs, or occurs alongside fever, rash, or a persistent headache may indicate a serious underlying condition and should be evaluated by a physician.

Before administering this medication, it is recommended to consult a healthcare provider if the child has a history of heart disease, high blood pressure, thyroid disease, diabetes, or if the cough is associated with excessive phlegm or is chronic, such as in cases of asthma. These considerations are essential to ensure the safe use of the medication and to mitigate the risk of adverse reactions.

Drug Interactions

The concomitant use of this product with monoamine oxidase inhibitors (MAOIs) is contraindicated in pediatric patients. MAOIs are typically prescribed for the treatment of depression, psychiatric disorders, emotional conditions, or Parkinson’s disease. Administration of this product should be avoided in children who are currently taking an MAOI or within 14 days following the discontinuation of such therapy.

Healthcare professionals are advised to confirm whether a child's prescription includes an MAOI prior to the administration of this product. If there is any uncertainty regarding the presence of an MAOI in the child's medication regimen, consultation with a physician or pharmacist is strongly recommended.

Packaging & NDC

Below are the non-prescription pack sizes of Signature Care Childrens Multi Symptom Cold (dextromethorphan hbr, guaifenesin, phenylephrine hcl). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 4 to 12 years may use this medication, with specific dosing guidelines based on age. Children 6 years to under 12 years should receive 10 mL every 4 hours, while those 4 years to under 6 years should receive 5 mL every 4 hours. The medication is not recommended for children under 4 years of age.

Healthcare professionals should advise caregivers to consult a doctor before administering this medication if the child has a history of heart disease, high blood pressure, thyroid disease, or diabetes. It is critical to avoid use in any child currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of stopping such medication.

Caregivers must ensure that the medication is kept out of reach of children and should be instructed to seek immediate medical assistance or contact a Poison Control Center (1-800-222-1222) in the event of an overdose. The maximum dosage should not exceed 6 doses within a 24-hour period, and the medication should only be measured using the dosing cup provided, which should not be used with other products.

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. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

The available prescribing information does not provide specific data regarding the use of this product during pregnancy. Consequently, the safety concerns, dosage modifications, or special precautions for pregnant patients remain undefined. Healthcare professionals should exercise caution when considering this product for women of childbearing potential and weigh the potential risks against the benefits. It is advisable to monitor any emerging data related to fetal outcomes as it becomes available.

Lactation

Lactating mothers should consult a healthcare professional 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

There is no specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution and consider individual patient factors when treating patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this medication. 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 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, as the clinical presentation can vary depending on the substance involved and the individual patient's response. Common symptoms of overdose may include, but are not limited to, altered mental status, cardiovascular instability, respiratory distress, and gastrointestinal disturbances.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should initiate supportive care, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs. The use of activated charcoal may be considered if the patient presents within a suitable timeframe and if the ingestion was recent.

Furthermore, specific antidotes or treatments may be indicated based on the substance involved in the overdose. Consultation with a poison control center or a medical toxicologist is recommended to guide the management of the patient effectively.

Overall, vigilance and prompt intervention are critical in managing cases of suspected overdose, even in the absence of detailed information regarding specific overdosage effects.

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, itching, and swelling. Neurological effects such as dizziness and drowsiness have also been noted. Gastrointestinal disturbances, including nausea and vomiting, were reported alongside cardiovascular effects like increased heart rate and elevated blood pressure. Additionally, symptoms of nervousness and restlessness were observed. More severe reactions included hallucinations, confusion, seizures, and respiratory depression.

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 in children who are currently taking a prescription monoamine oxidase inhibitor (MAOI) or within two weeks of stopping such medication. If patients are uncertain whether their child's prescription includes an MAOI, they should be encouraged to consult a doctor or pharmacist prior to administering this product.

Patients should be instructed to discontinue use and consult a doctor if their child experiences nervousness, dizziness, or sleeplessness. Additionally, they should be advised to stop use and seek medical advice if symptoms do not improve within seven days or if they are accompanied by fever. It is important to inform patients that they should also stop use and contact a doctor if a cough persists for more than seven days, recurs, or occurs with fever, rash, or a persistent headache, as these may indicate a serious condition.

While using this product, patients must be reminded not to exceed the recommended dosage. Healthcare providers should also encourage patients to consult a doctor before use if their child has any of the following conditions: heart disease, high blood pressure, thyroid disease, diabetes, a cough that produces excessive phlegm (mucus), or a persistent or chronic cough, such as that associated with asthma.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at a controlled room temperature of 20-25°C (68-77°F). Refrigeration is not recommended, as it may compromise the integrity of the product. Proper handling should be observed to maintain the quality and efficacy of the product throughout its shelf life.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients to keep the product out of reach of children and to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 in the event of an overdose. Patients should not exceed the recommended dosage and are instructed to discontinue use and consult a doctor if their child experiences nervousness, dizziness, or sleeplessness, if symptoms do not improve within 7 days or are accompanied by fever, or if a cough persists beyond 7 days, recurs, or occurs with fever, rash, or a persistent headache, as these may indicate a serious condition.

Patients should measure the dosage using the provided dosing cup and refrain from using it with other products. Dosing should be as specified or directed by a healthcare professional.

Drug Information (PDF)

This file contains official product information for Signature Care Childrens Multi Symptom Cold, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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