Giltuss Childrens Multisymptom Cold and Flu

Description

No description information is available for the drug.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains, including headache, minor sore throat pain, and cough due to minor throat and bronchial irritation associated with colds. It also alleviates symptoms of runny nose, sneezing, itchy nose or throat, and itchy watery eyes due to hay fever. Additionally, this drug is effective in reducing nasal and sinus congestion and temporarily lowers fever.

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

Dosage and Administration

For children under 6 years of age, the use of this medication is not recommended.

For children aged 6 to under 12 years, the recommended dosage is 5 mL administered every 4 to 6 hours as needed. The total dosage should not exceed 5 doses within a 24-hour period.

For children aged 12 years and older, the recommended dosage is 10 mL administered every 4 to 6 hours as needed. The total dosage should not exceed 6 doses within a 24-hour period.

The enclosed dosing cup should be utilized for accurate measurement of the dosage. It is advised to retain the dosing cup for future use with this product.

Contraindications

Use of this product is contraindicated in the following situations:

• In children under 4 years of age.

• In individuals with a known allergy to acetaminophen or any inactive ingredient in this product.

• In conjunction with any other medication containing acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in another medication, consultation with a healthcare professional is advised.

• In children currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such treatment. MAOIs are typically prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. If there is uncertainty about the presence of an MAOI in a prescription, a healthcare professional should be consulted.

• For the purpose of inducing sleep in children.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen. Healthcare professionals should advise patients that exceeding five doses within a 24-hour period, the maximum daily amount, or concomitant use with other medications containing acetaminophen significantly increases the risk of liver injury.

Acetaminophen is also associated with the potential for severe skin reactions. Symptoms indicative of such reactions may include skin reddening, blisters, and rash. In the event of any skin reaction, it is imperative to discontinue use immediately and seek medical assistance.

In cases of severe sore throat, particularly if it persists for more than two days or is accompanied by fever, headache, rash, nausea, or vomiting, patients should be instructed to consult a physician without delay.

General precautions must be emphasized, including the importance of keeping this product out of reach of children. In the event of an overdose, immediate medical attention is crucial. Healthcare providers should stress that prompt intervention is essential for both adults and children, even in the absence of noticeable signs or symptoms.

Patients should be advised to discontinue use and contact their healthcare provider if they experience nervousness, dizziness, or sleeplessness. Additionally, if pain, nasal congestion, or cough worsens or persists beyond five days, or if fever worsens or lasts more than three days, medical consultation is warranted. Redness or swelling, the emergence of new symptoms, or a cough that recurs or is accompanied by fever, rash, or headache that lasts should also prompt immediate medical evaluation.

Emergency medical assistance should be sought if any skin reaction occurs, necessitating the cessation of the product's use.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this product. Serious adverse reactions include severe liver damage, which may occur if the maximum daily dosage of acetaminophen is exceeded (more than 5 doses in 24 hours) or if the product is taken concurrently with other medications containing acetaminophen. Additionally, severe skin reactions have been reported, characterized by symptoms such as skin reddening, blisters, and rash. In the event of a skin reaction, patients should discontinue use immediately and seek medical assistance.

Common adverse reactions may include nervousness, dizziness, and sleeplessness. Patients should be advised to stop use and consult a healthcare professional if symptoms such as pain, nasal congestion, or cough worsen or persist beyond 5 days, if fever worsens or lasts more than 3 days, or if redness or swelling occurs. New symptoms or a recurrence of cough, particularly if accompanied by fever, rash, or headache, also warrant medical consultation.

Patients with pre-existing conditions should seek guidance from a healthcare provider prior to use. This includes individuals with liver disease, heart disease, high blood pressure, thyroid disease, diabetes, glaucoma, or chronic respiratory issues such as chronic bronchitis. Furthermore, patients should inform their healthcare provider if they are taking blood thinners like warfarin or any sedatives or tranquilizers, as these may interact with the product.

In cases of severe sore throat that persists for more than 2 days or is accompanied by fever, headache, rash, nausea, or vomiting, patients are advised to consult a doctor promptly.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there are no known interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Giltuss Childrens Multisymptom Cold and Flu (acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide, 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 6 to under 12 years, the recommended dosage is 5 mL every 4-6 hours, not to exceed 5 doses in a 24-hour period. For those aged 12 years and older, the dosage increases to 10 mL every 4-6 hours, with a maximum of 6 doses in 24 hours.

Severe liver damage may occur if the maximum daily dosage is exceeded or if the child is taking other medications containing acetaminophen. Additionally, acetaminophen may cause severe skin reactions, including symptoms such as skin reddening, blisters, or rash. If any skin reaction occurs, use should be discontinued immediately, and medical assistance should be sought.

Parents and caregivers should be aware of specific warnings: if a sore throat is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, a doctor should be consulted promptly. It is also advised to consult a healthcare professional before use if the child has liver disease, heart disease, high blood pressure, thyroid disease, diabetes, glaucoma, or respiratory issues such as chronic bronchitis or asthma.

Caution is warranted when this product is used in conjunction with blood thinners like warfarin or sedatives and tranquilizers. While using this medication, it is crucial not to exceed the recommended dosage, as marked drowsiness or excitability may occur, particularly in children. Parents should seek medical advice if the child experiences nervousness, dizziness, sleeplessness, worsening pain, nasal congestion, or cough lasting more than 5 days, fever lasting more than 3 days, redness or swelling, new symptoms, or if a cough recurs with fever, rash, or headache.

Geriatric Use

Elderly patients may not have specific information regarding the use of this product, as the prescribing information does not provide guidance on geriatric use. It is important to note that the product is primarily indicated for children, and therefore, it lacks directions or complete warnings pertinent to adult populations, including those aged 65 and older.

Healthcare providers should exercise caution when considering the use of this product in geriatric patients due to the absence of established safety and efficacy data in this demographic. Monitoring for potential adverse effects and evaluating the necessity of dosage adjustments based on individual patient factors may be prudent in the absence of specific recommendations.

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, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to discuss their individual circumstances with a healthcare provider to ensure safe use during pregnancy and lactation.

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

There is no information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution and consider the lack of specific guidance when prescribing to patients with reduced kidney function.

Hepatic Impairment

Patients with hepatic impairment should be closely monitored when using this product, as it contains acetaminophen, which poses a risk of severe liver damage. It is critical that patients do not exceed the maximum daily dosage of 5 doses within a 24-hour period. Additionally, patients must avoid concomitant use with other medications containing acetaminophen to prevent the risk of hepatotoxicity.

Healthcare providers should assess liver function prior to initiating treatment and consider regular monitoring of liver enzymes during therapy, particularly in patients with known liver dysfunction. Adjustments to the dosing regimen may be necessary based on the severity of hepatic impairment, and caution is advised to mitigate the risk of adverse effects related to liver function.

Overdosage

In the absence of specific overdosage information, it is essential for healthcare professionals to remain vigilant regarding the potential for overdose with this medication. In cases where an overdose is suspected, immediate medical attention should be sought.

Healthcare providers are advised to monitor patients closely for any signs or symptoms that may indicate an overdose. These may include, but are not limited to, increased severity of known side effects, altered mental status, or any unusual physiological responses.

Management of an overdose should be guided by the clinical presentation of the patient. Supportive care is paramount, and symptomatic treatment should be initiated as necessary. It is recommended that healthcare professionals consult local poison control centers or relevant toxicology resources for specific guidance on managing overdose cases.

In summary, while no specific overdosage information is available, healthcare professionals should exercise caution, remain alert to potential overdose symptoms, and implement appropriate management strategies as needed.

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 question. Further studies may be necessary to elucidate these aspects of nonclinical toxicology.

Postmarketing Experience

Acetaminophen has been associated with severe skin reactions reported in postmarketing experience. Symptoms of these reactions may include skin reddening, blisters, and rash. In the event of a skin reaction, it is advised to discontinue use immediately and seek medical assistance.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children. In the event of an overdose, it is crucial to seek medical help or contact a Poison Control Center immediately, as prompt medical attention is essential for both adults and children, even if no signs or symptoms are apparent.

Patients should be informed that this product is not suitable for children under 4 years of age. Additionally, it should not be used if the child has a known allergy to acetaminophen or any inactive ingredient in the formulation. It is important to avoid using this medication in conjunction with any other drug that contains acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in another medication, patients should be encouraged to consult a doctor or pharmacist.

Healthcare providers should caution against using this product in children who are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have taken one within the past two weeks. Patients should be advised to inquire with their healthcare provider or pharmacist if they are unsure whether their prescription medication contains an MAOI.

Patients should be informed that this medication is not intended to induce sleepiness in children. They should be instructed to discontinue use and consult a doctor if they experience nervousness, dizziness, or sleeplessness. Furthermore, if pain, nasal congestion, or cough worsens or persists for more than five days, or if fever worsens or lasts more than three days, patients should seek medical advice. Redness or swelling, the emergence of new symptoms, or a cough that returns or occurs with fever, rash, or a persistent headache should also prompt a consultation with a healthcare provider, as these may indicate a serious condition.

When using this product, it is imperative that patients do not exceed the recommended dosage. They should be made aware that marked drowsiness may occur, and excitability may be observed, particularly in children.

Patients should be encouraged to consult a doctor or pharmacist before using this medication if the child has any pre-existing conditions such as liver disease, heart disease, high blood pressure, thyroid disease, diabetes, glaucoma, or respiratory issues like chronic bronchitis or asthma. Additionally, it is advisable to seek professional guidance if the child is taking the blood-thinning medication warfarin or is on sedatives or tranquilizers.

Storage and Handling

The product is supplied in a configuration that includes a tightly sealed cap to ensure integrity. It is essential to store the product at room temperature, specifically within the range of 15° to 30°C (59° to 86°F). Healthcare professionals are advised to retain the carton for access to complete drug facts and additional information.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)