Giltuss Childrens Cough and Cold

Description

No description information is available for the drug.

Uses and Indications

This drug is indicated for the temporary relief of cough due to minor throat and bronchial irritation associated with the common cold or inhaled irritants. It reduces the intensity of coughing and decreases the impulse to cough. Additionally, this drug helps to loosen phlegm (mucus) and thin bronchial secretions, making coughs more productive and facilitating the drainage of bronchial tubes.

This medication also provides relief from nasal congestion, alleviates chest congestion, and relieves sinus pressure. It is effective in addressing symptoms associated with upper respiratory tract infections.

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

Dosage and Administration

The recommended dosage must not be exceeded. Patients should not take more than six doses within a 24-hour period. It is essential to use the dosing cup provided with this product for accurate measurement.

For children under 2 years of age, consultation with a healthcare professional is advised prior to administration.

For children aged 2 to under 6 years, the recommended dosage is 1.25 mL every 4 hours.

For children aged 6 to 12 years, the dosage increases to 2.5 mL every 4 hours.

For children aged 12 years and older, the appropriate dosage is 5 mL every 4 hours.

Healthcare professionals should ensure that caregivers are aware of these guidelines to promote safe and effective use of the product.

Contraindications

Use of this product is contraindicated in the following situations:

• It should not be used to sedate a child or induce sleepiness in a child.

• The 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. If there is uncertainty regarding the presence of an MAOI in a child's prescription medication, consultation with a healthcare professional is advised prior to administration.

Warnings and Precautions

The use of this product is contraindicated for sedation in children. It should not be administered to a child who is currently taking a prescription monoamine oxidase inhibitor (MAOI) or within two weeks of discontinuing such medication. 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.

General precautions must be observed 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, glaucoma, or a cough associated with excessive phlegm. Additionally, a consultation is warranted if the child is currently taking any other oral nasal decongestants, stimulants, sedatives, or tranquilizers.

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

Caregivers should be instructed to discontinue use and consult a healthcare professional if the child experiences nervousness, dizziness, or sleeplessness. Furthermore, if symptoms do not improve within seven days or are accompanied by fever, or if a cough persists beyond seven days, recurs, or is associated with fever, rash, or a persistent headache, medical advice should be sought. These symptoms may indicate a serious underlying condition that requires further evaluation.

Side Effects

Patients should be aware of the potential adverse reactions associated with the use of this product. Serious adverse reactions may occur, and it is crucial to monitor for specific symptoms. Patients should not use this product to sedate a child or to induce sleepiness. Additionally, it is contraindicated in children who are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have taken one within the past two weeks. If there is uncertainty regarding the presence of an MAOI in a child's prescription, consultation with a healthcare professional is advised.

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, glaucoma, or a cough that produces excessive phlegm. Furthermore, patients should seek medical advice if the child has a breathing problem or a persistent cough, such as that associated with asthma or chronic bronchitis.

Patients should also inform their healthcare provider or pharmacist if the child is taking any other oral nasal decongestants or stimulants, or if they are using sedatives or tranquilizers.

If any of the following symptoms occur, patients should discontinue use and consult a doctor: nervousness, dizziness, or sleeplessness. 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 occurs with fever, rash, or a persistent headache, these may indicate a serious condition requiring medical attention.

Drug Interactions

Dextromethorphan should not be administered to children who are concurrently taking a prescription monoamine oxidase inhibitor (MAOI) or within two weeks following the discontinuation of an MAOI. This precaution is due to the potential for serious interactions that may arise from the combination of these medications.

No additional drug interactions or drug and laboratory test interactions have been identified. Therefore, monitoring for interactions is not necessary beyond the specified contraindication with MAOIs.

Packaging & NDC

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

Pediatric Use

Pediatric patients should not use this medication if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have stopped taking an MAOI within the past 2 weeks. For children under 2 years of age, consultation with a healthcare provider is advised prior to use.

Recommended dosing for children is as follows: for those aged 2 to under 6 years, the dosage is 1.25 mL every 4 hours; for children aged 6 to 12 years, the dosage is 2.5 mL every 4 hours; and for adolescents aged 12 years and over, the dosage is 5 mL every 4 hours.

Before administering this medication, it is important to consult a healthcare provider if the child has any of the following conditions: heart disease, high blood pressure, thyroid disease, diabetes, glaucoma, a cough that produces excessive phlegm, or any breathing problems such as asthma or chronic bronchitis. Additionally, consultation is recommended if the child is taking any other oral nasal decongestants, stimulants, sedatives, or tranquilizers.

Parents and caregivers should discontinue use and seek medical advice if the child experiences nervousness, dizziness, or sleeplessness, if symptoms do not improve within 7 days or are accompanied by fever, or if a cough persists for more than 7 days, recurs, or occurs with fever, rash, or a persistent headache.

Geriatric Use

There is no specific information available 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

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 considered in these populations to ensure the safety of both the mother and the fetus or infant.

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 not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

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 aware that the symptoms of 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 specific antidotes are available, their administration should be considered based on the clinical scenario and the substance involved.

It is essential for healthcare providers to remain vigilant and prepared to implement emergency protocols in the event of an overdose, ensuring the best possible outcomes for affected individuals.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to use. There are no specific non-teratogenic effects or detailed nonclinical toxicology findings available. Additionally, no specific information regarding animal pharmacology and toxicology has been provided.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions associated with the use of Giltuss Children's Cough & Cold. Reports indicate that some patients may experience nervousness, dizziness, and sleeplessness. These reactions have been documented through voluntary reporting and surveillance programs.

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 or contact a Poison Control Center immediately.

It is important to inform patients that this medication should not be used to sedate a child or induce sleepiness. Additionally, healthcare providers should emphasize that this medication must not be administered to a child who is 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 use.

Patients should be instructed to discontinue use and consult a doctor if they experience nervousness, dizziness, or sleeplessness. Furthermore, they should be advised to seek medical advice if symptoms do not improve within seven days or if they are accompanied by fever. If a cough persists for more than seven days, recurs, or occurs with fever, rash, or a persistent headache, patients should also be directed to stop use and contact a healthcare professional.

Healthcare providers should recommend that patients consult a doctor before using this medication if the child has any of the following conditions: heart disease, high blood pressure, thyroid disease, diabetes, glaucoma, or a cough associated with excessive phlegm. Additionally, patients should be advised to seek medical advice if the child has a breathing problem or a persistent or chronic cough, such as that which occurs with asthma or chronic bronchitis.

Lastly, patients should be encouraged to consult a doctor or pharmacist before using this medication if the child is taking any other oral nasal decongestant or stimulant, as well as if the child is on sedatives or tranquilizers.

Storage and Handling

The product is supplied in a configuration that includes a tamper-evident seal. It is essential to ensure that the safety seal is intact before use; the product should not be utilized if the seal is broken or missing.

For optimal storage, the product must be kept at room temperature, within the range of 15° to 30°C (59° to 86°F). It is important to close the cap tightly after each use to maintain the integrity of the product.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. It is important to keep the medication out of reach of children, and in the event of an overdose, patients should seek medical assistance or contact a Poison Control Center immediately.

Drug Information (PDF)

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

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