Childrens Coltalin

Description

No description information is available for the specified drug.

Uses and Indications

This drug is indicated for the temporary relief of symptoms associated with the common cold, influenza, or hay fever. These symptoms include sore throat, minor aches and pains, headache, itching of the nose or throat, runny nose, sneezing, itchy and watery eyes due to hay fever, sinus congestion and pressure, and nasal congestion. Additionally, this drug temporarily reduces fever and promotes nasal and/or sinus drainage.

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

Dosage and Administration

For children aged 6 to under 12 years, the recommended dosage is 4 chewable tablets every 4 hours while symptoms persist. The total daily dosage should not exceed 5 doses, equating to a maximum of 20 tablets in a 24-hour period, unless otherwise directed by a healthcare professional. It is important that the tablets are chewed thoroughly before swallowing.

For children under 6 years of age, it is advised to consult a healthcare professional for appropriate dosing recommendations.

Contraindications

Use of this product is contraindicated in the following situations:

Children under 6 years of age should not be given this product unless directed by a physician. Co-administration with any other drug containing acetaminophen, whether prescription or nonprescription, is contraindicated due to the risk of acetaminophen overdose. Additionally, this product should not be used in children currently taking a prescription monoamine oxidase inhibitor (MAOI), as this may lead to serious interactions. Furthermore, use is contraindicated for 2 weeks following the discontinuation of an MAOI to avoid potential adverse effects.

Warnings and Precautions

Severe liver damage may occur in patients taking this product, which contains acetaminophen, if they exceed the maximum daily dosage of 5 doses within a 24-hour period or if they concurrently use other medications containing acetaminophen.

It is imperative that this product is not administered to children under 6 years of age unless specifically directed by a healthcare professional. Additionally, this product should be stored out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or a Poison Control Center should be contacted without delay. Prompt medical attention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Healthcare professionals should advise patients to discontinue use and consult a physician if any of the following occur: sore throat persists for more than 2 days, sore throat is severe, or if the sore throat is accompanied or followed by fever, headache, rash, nausea, or vomiting. Furthermore, if pain or nasal congestion worsens or lasts longer than 5 days, or if fever intensifies or persists beyond 3 days, medical advice should be sought. Patients should also be instructed to seek medical attention if redness or swelling is observed, if new symptoms arise, or if they experience nervousness, dizziness, or sleeplessness.

No specific laboratory tests are recommended for monitoring during the use of this product.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this product. Serious adverse reactions include the potential for severe liver damage, particularly in cases where patients exceed the maximum recommended dosage of five doses within a 24-hour period or when used concurrently with other medications containing acetaminophen.

Common adverse reactions that warrant immediate medical attention include persistent sore throat lasting more than two days, severe sore throat, or sore throat accompanied by fever, headache, rash, nausea, or vomiting. Additionally, worsening pain or nasal congestion lasting more than five days, fever that worsens or persists beyond three days, and the presence of redness or swelling should prompt patients to seek medical advice. New symptoms, as well as the occurrence of nervousness, dizziness, or sleeplessness, are also indications to consult a healthcare professional.

Patients with pre-existing conditions should exercise caution and consult a doctor before use if they have liver disease, heart disease, high blood pressure, thyroid disease, diabetes, glaucoma, or a breathing problem such as chronic bronchitis. Furthermore, individuals taking blood thinners such as warfarin, sedatives, tranquilizers, or any prescription medications without knowledge of their MAOI content should seek guidance from a doctor or pharmacist prior to using this product.

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 necessary at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Childrens Coltalin (acetaminophen, chlorpheniramine maleate, phenylephrine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 6 years of age should not be given this medication unless directed by a healthcare professional. For children aged 6 to under 12 years, the recommended dosage is 4 chewable tablets every 4 hours while symptoms persist, with a maximum of 5 doses (20 tablets) in a 24-hour period, or as directed by a physician. It is important for children in this age group to chew the tablet thoroughly before swallowing. Parents and caregivers are advised to consult a doctor for any child under 6 years of age regarding the use of this medication.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any potential 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 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 mothers.

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 to adhere to the maximum daily dosage of 5 doses within a 24-hour period. Exceeding this limit, particularly in conjunction with other medications containing acetaminophen, may significantly increase the risk of liver injury.

Healthcare providers are advised to evaluate liver function prior to initiating treatment and to consider the potential for dose adjustments or alternative therapies in patients with compromised liver function. Regular monitoring of liver enzymes may be warranted to ensure patient safety and to mitigate the risk of hepatotoxicity.

Overdosage

In the absence of specific overdosage information, it is essential for healthcare professionals to remain vigilant and consider general principles of management in cases of suspected overdose.

Healthcare providers should be aware that the clinical presentation of an overdose may vary significantly depending on the substance involved, the amount ingested, and the individual patient's characteristics. Symptoms may include, but are not limited to, altered mental status, cardiovascular instability, respiratory distress, and gastrointestinal disturbances.

In the event of an overdose, immediate medical attention is warranted. The following steps are recommended for the management of suspected overdose cases:

1. Assessment: Conduct a thorough assessment of the patient's clinical status, including vital signs and level of consciousness.

2. Supportive Care: Initiate supportive care measures as necessary, which may include airway management, oxygen supplementation, and intravenous fluids.

3. Decontamination: If the overdose is recent and the patient is alert and able to protect their airway, consider activated charcoal administration to limit further absorption of the substance.

4. Specific Antidotes: If applicable, identify and administer any specific antidotes that may be indicated for the substance involved in the overdose.

5. Monitoring: Continuous monitoring of the patient’s vital signs and clinical status is crucial, as symptoms may evolve over time.

6. Consultation: Engage with a poison control center or toxicology expert for guidance on specific management strategies tailored to the substance involved.

In summary, while no specific overdosage information is provided, healthcare professionals should be prepared to implement general overdose management protocols and seek specialized assistance as needed.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to use.

The substance may induce drowsiness, and the concomitant use of sedatives or tranquilizers may enhance this effect. Additionally, excitability has been observed, particularly in pediatric populations.

No information is available regarding carcinogenicity, mutagenicity, or impairment of fertility. Furthermore, there is no data provided concerning animal pharmacology and toxicology.

Postmarketing Experience

Serious adverse events associated with the use of this product have been reported voluntarily or identified through surveillance programs. These reports contribute to the ongoing assessment of the product's safety profile.

Patient Counseling

Healthcare providers should advise patients that this medication is not recommended for children under 6 years of age unless specifically directed by a physician. It is important to emphasize the necessity of keeping 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 immediately or contact a Poison Control Center. Healthcare providers should stress that prompt medical attention is crucial for both adults and children, even if no signs or symptoms of overdose are apparent. This information is vital for ensuring the safety and well-being of patients.

Storage and Handling

The product is supplied in packaging that ensures protection from light. It should be stored in a dry place, maintaining a temperature range of 15 to 30°C (59 to 86°F) to ensure optimal stability and efficacy. Special care should be taken to avoid exposure to light during storage.

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

For any questions or comments, patients can contact the provided helpline at (888) 221-3496, available Monday through Friday from 9 am to 5 pm. This number can also be used to report serious adverse events related to the medication.

Drug Information (PDF)

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

View product document (PDF)