Pediacare Childrens Cough and Congestion Grape

Description

Dextromethorphan HBr, USP is present at a concentration of 5 mg per 5 mL, while Guaifenesin, USP is included at 100 mg per 5 mL. The formulation is flavored with grape and is provided in a dosage form of a liquid. Each bottle contains 4 fluid ounces (118 mL) of the product.

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 of the bronchial tubes.

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

Dosage and Administration

The maximum dosage for this product is 6 doses within a 24-hour period. It is imperative that the dosing cup provided with the product is used for accurate measurement, and it should be kept with the product at all times.

For children under 4 years of age, the use of this product is not recommended. For children aged 4 to under 6 years, the recommended dosage is 5 mL every 4 hours. For children aged 6 to under 12 years, the dosage increases to 10 mL every 4 hours. Adults and children aged 12 years and older should take 20 mL every 4 hours.

Healthcare professionals should ensure that patients adhere to these guidelines to avoid exceeding the maximum dosage limit.

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.

Warnings and Precautions

Use of this product is contraindicated in individuals currently taking prescription monoamine oxidase inhibitors (MAOIs), which are commonly prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. Additionally, it is advised to refrain from using this product for at least two weeks following the discontinuation of an MAOI. Healthcare professionals should be consulted if there is uncertainty regarding the presence of an MAOI in a prescription medication.

Patients should discontinue use and seek medical advice if a cough persists for more than seven days, recurs, or is accompanied by symptoms such as fever, rash, or a persistent headache. These symptoms may indicate a more serious underlying condition that requires further evaluation.

In the event of an overdose, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended to ensure appropriate management.

For individuals who are pregnant or breastfeeding, it is essential to consult a healthcare professional prior to using this product to assess potential risks.

This product should be stored out of reach of children to prevent accidental ingestion or misuse.

Side Effects

Patients should be aware of the following adverse reactions associated with the use of this medication.

Serious adverse reactions may occur, particularly in patients who are currently taking or have recently discontinued a prescription monoamine oxidase inhibitor (MAOI). The use of this medication is contraindicated in such cases, as it may lead to significant health risks.

Common adverse reactions include the potential for cough that is accompanied by excessive phlegm or that persists for an extended period. Patients with chronic cough due to conditions such as smoking, asthma, chronic bronchitis, or emphysema should consult a healthcare professional before using this medication.

Patients are advised to discontinue use and seek medical attention if their cough lasts more than 7 days, recurs, or is accompanied by additional symptoms such as fever, rash, or persistent headache, as these may indicate a serious underlying condition.

For pregnant or breastfeeding patients, it is recommended to consult a healthcare professional prior to use to ensure safety for both the mother and child.

Additionally, this medication should be kept out of reach of children. 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. MAOIs are typically prescribed for the treatment of depression, psychiatric disorders, emotional conditions, or Parkinson's disease. Patients should not take this product while on MAOIs or within 2 weeks of discontinuing an MAOI. It is essential for patients to consult with a healthcare professional, such as a doctor or pharmacist, to confirm whether their current prescription includes an MAOI before initiating treatment with this product.

Packaging & NDC

Below are the non-prescription pack sizes of Pediacare Childrens Cough and Congestion Grape (dextromethorphan hydrobromide and guaifenesin). 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, while for those aged 6 to under 12 years, the dosage is 10 mL every 4 hours. It is important to note that no more than 6 doses should be administered within a 24-hour period.

Healthcare professionals should ensure that this medication is kept out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center without delay.

Geriatric Use

There is no specific information regarding the use of Pediacare Children's Cough and Congestion Grape in geriatric patients. Therefore, healthcare providers should exercise caution when considering this medication for elderly patients. Due to the lack of clinical data, it is advisable to monitor this population closely for any adverse effects or unusual responses to treatment. Additionally, dosage adjustments may be necessary based on individual patient factors, including comorbidities and concurrent medications.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure the safety of both the mother and the developing fetus.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data regarding the excretion of this medication 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 may not have specific dosage adjustments, special monitoring, or safety considerations outlined in the prescribing information. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals 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 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

If pregnant or breast-feeding, it is advised to consult a health professional before 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

Postmarketing experience has identified the following adverse reactions reported voluntarily or through surveillance programs: allergic reactions, which include anaphylaxis, skin reactions, and respiratory issues.

Patient Counseling

Healthcare providers should advise patients to keep the medication 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 must be informed not to use this medication if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have stopped taking an MAOI drug within the last two weeks. 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 also counsel patients to discontinue use and seek medical advice if their cough persists for more than 7 days, returns, or is accompanied by symptoms such as fever, rash, or a persistent headache, as these may indicate a serious condition.

Additionally, patients should be advised to consult a doctor before using this medication if they have a cough that produces excessive phlegm (mucus) or if they have a chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema.

Storage and Handling

The product is supplied in a configuration that is alcohol-free. It should be stored at a controlled room temperature of 20-25°C (68-77°F). It is essential to avoid refrigeration to maintain the integrity of the product. Proper handling and storage conditions are crucial to ensure optimal quality and efficacy.

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 Pediacare Childrens Cough and Congestion Grape, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)