Amazon

Description

No description information is available for the specified drug.

Uses and Indications

This drug is indicated for the relief of cough associated with minor throat and bronchial irritation, which may occur due to the common cold or inhaled irritants. It aids in loosening phlegm (mucus) and thinning bronchial secretions, thereby facilitating the clearance of mucus from the bronchial passageways and making coughs more productive.

Additionally, this drug temporarily relieves the intensity of coughing and the impulse to cough, which may assist children in achieving restful sleep. It also alleviates nasal congestion and a stuffy nose associated with colds.

There are no teratogenic or nonteratogenic effects reported for this drug.

Dosage and Administration

The maximum recommended dosage is six doses within a 24-hour period. Dosing should be measured exclusively with the dosing cup provided, and this cup should not be used with any other products to ensure accurate dosing.

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 recommended dose is 5 mL every 4 hours. It is contraindicated to use this product in children under 4 years of age.

Healthcare professionals should advise caregivers to follow these dosing instructions or any additional directions provided by a physician.

Contraindications

Use of this product is contraindicated in children who are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have discontinued MAOI therapy within the past two weeks. This contraindication is due to the potential for serious interactions that may arise from the combination of these medications. Additionally, the product should not be used in excess of the recommended 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.

Prior to administration, it is essential to consult a healthcare provider if the child has any of the following conditions: heart disease, high blood pressure, thyroid disease, diabetes, a cough associated with excessive phlegm (mucus), or a persistent or chronic cough, such as that which occurs with asthma.

During the use of this product, it is imperative to adhere strictly to the recommended dosage. Exceeding the directed dosage may lead to adverse effects.

Caregivers should be instructed to discontinue use and seek medical advice if the child experiences nervousness, dizziness, or sleeplessness. Additionally, if symptoms do not improve within seven days, or if they are accompanied by fever, or if a cough persists for more than seven days, recurs, or is associated with fever, rash, or a persistent headache, medical evaluation is warranted as these may indicate a serious underlying condition.

This product should be stored out of reach of children. 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.

Side Effects

Patients may experience a range of adverse reactions while using this product. It is important to monitor for serious symptoms that may require medical attention. Patients should stop use and consult a healthcare professional if they experience nervousness, dizziness, or sleeplessness. Additionally, if symptoms do not improve within 7 days, or if they occur alongside fever, it is advised to seek medical advice. A cough that persists for more than 7 days, recurs, or is accompanied by fever, rash, or a persistent headache may indicate a serious condition and should be evaluated by a healthcare provider.

Before using this product, it is recommended that patients consult a doctor if the child has any of the following conditions: heart disease, high blood pressure, thyroid disease, diabetes, or a cough that produces excessive phlegm. Special caution is warranted for children with a persistent or chronic cough, such as that associated with asthma.

Warnings are in place regarding the use of this product in children who are currently taking or have recently stopped taking a prescription monoamine oxidase inhibitor (MAOI). This includes certain medications prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. The product should not be administered to these children or within 2 weeks of discontinuing an MAOI. If there is uncertainty regarding the presence of an MAOI in a child's prescription medication, it is essential to consult a doctor or pharmacist prior to use.

Drug Interactions

The use of this medication is contraindicated in pediatric patients who are concurrently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing an MAOI. Co-administration may result in serious interactions that could pose significant health risks.

No additional drug interactions or laboratory test interactions have been identified for this medication. Therefore, no further dosage adjustments or monitoring recommendations are necessary beyond the aforementioned contraindication.

Packaging & NDC

Below are the non-prescription pack sizes of Amazon (dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients should not use this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of stopping an MAOI. Prior to use, it is advisable to consult a healthcare professional if the child has any of the following conditions: heart disease, high blood pressure, thyroid disease, diabetes, cough with excessive phlegm, or a persistent cough such as that associated with asthma.

When administering this product, it is crucial to adhere to the recommended dosage and not exceed 6 doses within a 24-hour period. The dosing should be measured using the provided dosing cup, which should not be used with other products. The recommended dosages are as follows: for children aged 6 years to under 12 years, 10 mL every 4 hours; for children aged 4 years to under 6 years, 5 mL every 4 hours. This product is not recommended for children under 4 years of age.

Parents or caregivers should discontinue use and consult a healthcare professional if the child experiences nervousness, dizziness, or sleeplessness, if symptoms do not improve within 7 days, or if the cough persists for more than 7 days, recurs, or is accompanied by fever, rash, or a persistent headache.

Geriatric Use

There is no specific information regarding the use of Amazon Children's Multi-Symptom Cold in geriatric patients. The prescribing information does not provide recommended age considerations, dosage adjustments, safety concerns, or special precautions for elderly patients. Therefore, healthcare providers should exercise caution and consider individual patient factors when prescribing this medication to geriatric patients, as the absence of data does not preclude the need for careful monitoring and assessment of treatment efficacy and safety in this population.

Pregnancy

There are no specific statements regarding the use of this product during pregnancy. The available data does not indicate any safety concerns or contraindications related to pregnancy. Additionally, no dosage modifications for pregnant individuals are provided, and there are no special precautions regarding the use of this product during pregnancy. Healthcare professionals should consider the absence of specific information when advising pregnant patients or women of childbearing potential.

Lactation

There are no specific warnings or recommendations regarding the use of this product in nursing mothers. Additionally, there is no information available about the potential for excretion in breast milk or any associated risks to breastfed infants.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the prescribing information regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment and monitoring of these patients.

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. Healthcare professionals are advised to contact a Poison Control Center without delay. The national helpline for poison control can be reached at 1-800-222-1222.

Prompt intervention is crucial in managing overdose situations. Symptoms may vary depending on the substance involved, and healthcare providers should be prepared to assess and address any potential complications that may arise. It is essential to monitor the patient closely and provide supportive care as needed.

Management procedures should include a thorough evaluation of the patient's condition, including vital signs and any presenting symptoms. Depending on the severity of the overdose, treatment may involve decontamination, administration of antidotes, or other supportive measures as deemed appropriate by the medical team.

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 the following adverse reactions reported voluntarily or through surveillance programs: nervousness, dizziness, and sleeplessness. These reactions may occur with the use of this product.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. In the event of an overdose, patients should be instructed to seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

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.

Patients should be instructed to discontinue use and consult a doctor if they experience nervousness, dizziness, or sleeplessness. Additionally, if symptoms do not improve within seven days, or if they are accompanied by fever, or if a cough persists for more than seven days, recurs, or occurs with fever, rash, or a persistent headache, they should seek medical advice, as these may indicate a serious condition.

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

Storage and Handling

The product is supplied with a dosing cup included for accurate measurement. It should be stored at room temperature and must not be refrigerated to maintain its efficacy. Proper handling is essential to ensure the integrity of the product throughout its shelf life.

Additional Clinical Information

The medication is administered orally. There are no additional details available regarding laboratory tests, abuse information, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Amazon, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)