Childrens Robitussin Cough and Cold Cf

Description

DEXTROMETHORPHAN HBr serves as a cough suppressant, while GUAIFENESIN functions as an expectorant, and PHENYLEPHRINE HCl acts as a nasal decongestant. This formulation is designed to provide non-drowsy relief from cough and congestion. The product is presented in a grape flavor and is available in a dosage form of 4 fluid ounces (118 mL).

Uses and Indications

This drug is indicated for the relief of symptoms associated with colds, specifically nasal congestion and cough due to minor throat and bronchial irritation. It aids in loosening phlegm (mucus) and thinning bronchial secretions, facilitating drainage of the bronchial tubes.

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

Dosage and Administration

Healthcare professionals should ensure that the dosing cup provided with the product is used exclusively for measuring doses. The dosing cup should be kept with the product at all times to facilitate accurate measurement.

For administration, the following dosage guidelines are recommended based on age:

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

• Children 4 to under 6 years: Administer 5 mL every 4 hours as needed, not to exceed 6 doses in a 24-hour period.

• Children 6 to under 12 years: Administer 10 mL every 4 hours as needed, not to exceed 6 doses in a 24-hour period.

• Adults and children 12 years and over: Administer 20 mL every 4 hours as needed, not to exceed 6 doses in a 24-hour period.

It is imperative that no more than 6 doses are taken within any 24-hour period to avoid potential overdose.

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 a period of 2 weeks following the discontinuation of an MAOI. Patients should consult a healthcare professional if they are uncertain whether their prescription medication contains an MAOI.

Exceeding the recommended dosage is also contraindicated while using this product.

Warnings and Precautions

Use of this product is contraindicated in 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 cessation of an MAOI. Healthcare professionals should advise patients to consult with a doctor or pharmacist if they are uncertain whether their prescription medication contains an MAOI.

Prior to use, patients should be instructed to seek medical advice if they have any of the following conditions: heart disease, high blood pressure, thyroid disease, diabetes, difficulty urinating due to an enlarged prostate gland, or a cough that is productive of excessive phlegm. Furthermore, individuals with a chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema should also consult a healthcare provider.

Patients should be cautioned against the concurrent use of this product with any other oral nasal decongestants or stimulants without prior consultation with a doctor or pharmacist.

It is imperative that patients adhere strictly to the recommended dosage and not exceed the directed amount. Should any of the following occur, patients must discontinue use and seek medical advice: feelings of nervousness, dizziness, or sleeplessness; lack of improvement in symptoms within seven days; or if a cough persists beyond seven days, recurs, or is accompanied by fever, rash, or a persistent headache, 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 contact with a Poison Control Center should be made without delay.

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 individuals with specific pre-existing conditions. It is contraindicated for patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or for those who have discontinued MAOI therapy within the past two weeks.

Common adverse reactions include nervousness, dizziness, and sleeplessness. Patients experiencing these symptoms should discontinue use and consult a healthcare professional. Additionally, if symptoms do not improve within seven days or 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, patients should seek medical advice, as these may indicate a serious underlying condition.

Patients with a history of heart disease, high blood pressure, thyroid disease, diabetes, or urinary difficulties due to an enlarged prostate gland should consult a healthcare provider before using this medication. Furthermore, individuals with a cough that produces excessive phlegm or those with chronic respiratory conditions such as smoking-related cough, asthma, chronic bronchitis, or emphysema should also seek medical guidance prior to use.

It is advisable for patients to inform their healthcare provider or pharmacist if they are taking any other oral nasal decongestants or stimulants, as this may influence the safety and efficacy of the treatment.

Drug Interactions

The concomitant use of this product with prescription monoamine oxidase inhibitors (MAOIs) is contraindicated. Patients should not take this product while on MAOIs or for a period of two weeks following the discontinuation of an MAOI. MAOIs are commonly prescribed for depression, psychiatric or emotional conditions, and Parkinson's disease. If patients are uncertain whether their prescription medication contains an MAOI, they are advised to consult a healthcare professional, such as a doctor or pharmacist, prior to using this product.

Additionally, it is recommended that patients seek guidance from a healthcare provider before using this product in conjunction with any other oral nasal decongestants or stimulants. This precaution is essential to avoid potential adverse interactions and ensure safe use.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 4 years of age should not use this medication. For children aged 4 to under 6 years, the recommended dosage is 5 mL every 4 hours. In children aged 6 to under 12 years, the dosage increases to 10 mL every 4 hours. For adolescents and adults aged 12 years and older, the dosage is 20 mL every 4 hours. It is important to note that individuals must be 18 years or older to purchase this medication.

Geriatric Use

There is no specific information regarding the use of Children's Robitussin Cough and Cold CF in geriatric patients. Therefore, healthcare providers should exercise caution when considering this medication for elderly patients. It is advisable to monitor for potential adverse effects and to assess the appropriateness of the dosage, as older adults may have altered pharmacokinetics and pharmacodynamics. Given the lack of targeted studies or data, individualized treatment plans should be developed, taking into account the overall health status and comorbidities of geriatric patients.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is important to evaluate the potential risks and benefits associated with the use of this drug during pregnancy and lactation. Healthcare providers can offer guidance based on individual circumstances and the latest clinical data.

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

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

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 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 vigilant in monitoring for symptoms that may arise from an overdose. While specific symptoms are not detailed in the provided information, it is essential to be aware that they can vary based on the substance involved and the individual patient’s response.

Management of an overdose typically involves supportive care and symptomatic treatment. Healthcare providers should ensure that the patient is stabilized and closely monitored throughout the treatment process. It is advisable to follow established protocols for overdose management, which may include administering activated charcoal if appropriate and ensuring the patient receives comprehensive medical evaluation and care.

In summary, immediate action is critical in the case of an overdose, and healthcare professionals should be prepared to implement appropriate management strategies to ensure patient safety and recovery.

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

No postmarketing experience details are available for SPL code 90375-7.

Patient Counseling

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

Patients should be informed that this product should not be used if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of stopping an MAOI. If patients are uncertain whether their prescription medication contains an MAOI, they should be encouraged to consult with their doctor or pharmacist prior to using this product.

Healthcare providers should counsel patients to discontinue use and seek medical advice if they experience symptoms such as nervousness, dizziness, or sleeplessness. Additionally, patients should be advised to stop using the product and consult a doctor if their symptoms do not improve within 7 days or if they are accompanied by fever. Patients should also be instructed to stop use and seek medical attention if their cough persists for more than 7 days, returns, or is accompanied by fever, rash, or a persistent headache, as these may indicate a serious condition.

When using this product, patients should be reminded not to exceed the recommended dosage. It is important for healthcare providers to ask patients about their medical history and advise them to consult a doctor before use if they have heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate gland. Patients should also be encouraged to seek medical advice if they have a cough that produces excessive phlegm or if they have a chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema. Lastly, patients should be advised to consult a doctor or pharmacist before using this product if they are taking any other oral nasal decongestant or stimulant.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers. It should be stored at a temperature range of 20-25°C (68-77°F). It is important to note that refrigeration is not permitted for this product. Proper storage conditions must be maintained to ensure the integrity and efficacy of the product.

Additional Clinical Information

Patients must be 18 years or older to purchase the medication. Clinicians are advised to inform parents about the potential for medicine abuse among teenagers and can direct them to resources such as www.StopMedicineAbuse.org for further information. No additional details are available regarding laboratory tests, routes of administration, patient counseling, or postmarketing experiences.

Drug Information (PDF)

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

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