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. Specifically, it alleviates minor aches and pains, sore throat, headache, runny nose, sinus congestion and pressure, nasal congestion due to a cold or hay fever, as well as sneezing, itching of the nose or throat, and itchy, watery eyes resulting from hay fever. 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 adults and children aged 12 years and over, the recommended dosage is 2 tablets every 4 hours as needed while symptoms persist. The total daily dosage should not exceed 6 doses (12 tablets) within a 24-hour period, unless otherwise directed by a healthcare professional.

For children aged 6 to under 12 years, the recommended dosage is 1 tablet every 4 hours as needed while symptoms persist. The total daily dosage should not exceed 5 doses (5 tablets) within a 24-hour period, unless otherwise directed by a healthcare professional.

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:

• Concurrent use with any other drug containing acetaminophen, whether prescription or nonprescription, due to the risk of acetaminophen overdose.

• In patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing an MAOI, as this may lead to serious drug interactions. If there is uncertainty regarding the presence of an MAOI in a prescription medication, consultation with a healthcare professional is advised.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen. Healthcare professionals should be aware of the following critical warnings regarding liver safety:

Liver Warning

• Adults should not exceed 12 tablets in a 24-hour period, as this is the maximum daily dosage.

• For children, the maximum is 5 doses within 24 hours.

• Caution is advised when this product is taken in conjunction with other medications containing acetaminophen.

• Adults consuming three or more alcoholic beverages daily while using this product are at increased risk for liver damage.

Allergy Alert Acetaminophen may lead to severe skin reactions. Symptoms indicative of such reactions include skin reddening, blisters, and rash. Should any skin rash develop, it is imperative to discontinue use immediately and seek medical assistance.

General Precautions This product should be kept out of reach of children. In the event of an overdose, it is crucial to obtain medical help or contact a Poison Control Center without delay. Prompt medical attention is essential for both adults and children, even if no signs or symptoms are initially apparent.

Emergency Medical Help In cases of overdose, immediate medical assistance or contact with a Poison Control Center is necessary.

Consult a Healthcare Provider Patients should be advised to stop taking this product and consult a healthcare provider if any of the following occur:

• Pain or nasal congestion worsens or persists beyond 5 days in children or 7 days in adults.

• A sore throat lasts more than 2 days.

• Fever worsens or lasts more than 3 days.

• Nasal congestion is accompanied by fever.

• Symptoms of nervousness, dizziness, or sleeplessness arise.

• Redness or swelling is observed.

• New symptoms develop.

• Any of the following serious conditions are suspected:

  • Severe sore throat.

  • Sore throat accompanied or followed by fever, headache, rash, nausea, or vomiting.

Healthcare professionals should remain vigilant in monitoring patients for these signs and symptoms to ensure safe use of this product.

Side Effects

Severe liver damage may occur in patients who exceed the recommended dosage of this product. Specifically, adults should not take more than 12 tablets in a 24-hour period, while children should not exceed 5 doses in the same timeframe. The risk of liver damage is heightened if the product is taken in conjunction with other medications containing acetaminophen or if an adult consumes 3 or more alcoholic drinks daily while using this product.

Patients should be aware of the potential for severe skin reactions associated with acetaminophen. Symptoms may include skin reddening, blisters, and rash. In the event of a skin rash, patients are advised to discontinue use immediately and seek medical assistance.

Additional adverse reactions warranting medical consultation include worsening pain or nasal congestion lasting more than 5 days in children or 7 days in adults, persistent sore throat for more than 2 days, and fever that worsens or lasts more than 3 days. Patients should also seek medical advice if nasal congestion is accompanied by fever, or if they experience nervousness, dizziness, or sleeplessness. Redness or swelling, the emergence of new symptoms, or any of the following serious conditions should prompt immediate medical attention: severe sore throat, sore throat accompanied or followed by fever, headache, rash, nausea, or vomiting.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding 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 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 receive this medication unless directed by a healthcare professional. For children aged 6 to under 12 years, the recommended dosage is 1 tablet every 4 hours as needed for symptom relief, with a maximum of 5 doses (5 tablets) within a 24-hour period, unless otherwise directed by a physician. It is essential to consult a doctor for any pediatric patient under 6 years of age before administration.

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 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 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 specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in this patient population.

Hepatic Impairment

Patients with hepatic impairment should exercise caution when using this product, which contains acetaminophen. It is important to note that severe liver damage may occur under certain conditions. Specifically, adults should not exceed 12 tablets in a 24-hour period, as this is the maximum daily amount for this product. For pediatric patients, the maximum is limited to 5 doses in a 24-hour period.

Additionally, patients with compromised liver function should be aware of the risks associated with concurrent use of other medications containing acetaminophen, as this can further increase the likelihood of liver damage. Furthermore, adults who consume 3 or more alcoholic drinks daily while using this product are at an elevated risk for severe liver injury.

Due to these considerations, it is advisable for patients with hepatic impairment to consult with a healthcare professional prior to using this product to ensure safe and appropriate use. Regular monitoring of liver function may be warranted in these patients to detect any potential adverse effects early.

Overdosage

In cases of overdosage, significant health risks are associated with exceeding the recommended dosage of this product.

Adults For adults, the maximum recommended daily dosage is 12 tablets within a 24-hour period. Ingesting more than this amount may lead to severe liver damage. Healthcare professionals should monitor patients closely for symptoms of liver impairment, which may include jaundice, abdominal pain, and elevated liver enzymes.

Pediatrics In pediatric patients, the threshold for potential severe liver damage is lower. If a child consumes more than 5 doses within a 24-hour period, there is a risk of significant hepatic injury. Symptoms to watch for in children may mirror those in adults, including signs of jaundice and abdominal discomfort.

Management Procedures In the event of suspected overdosage, immediate medical attention is warranted. Healthcare providers should initiate supportive care and consider the need for further interventions based on the severity of symptoms and liver function tests. It is crucial to assess the patient's condition promptly to mitigate the risk of long-term liver damage.

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 compound in these areas.

Postmarketing Experience

Postmarketing experience has identified that acetaminophen may be associated with severe skin reactions. Reports indicate that symptoms can include skin reddening, blisters, and rash. In the event of a skin rash, it is advised to discontinue use and seek medical assistance immediately. Additionally, serious side effects can be reported through the designated contact number provided.

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. It is important to emphasize that prompt medical attention is critical for both adults and children, even if no signs or symptoms are initially apparent.

Patients should be cautioned not to exceed the recommended dosage, as doing so may lead to adverse effects. Healthcare providers should inform patients that the medication may cause excitability, particularly in children, and advise them to use caution when driving or operating machinery due to potential drowsiness.

Additionally, patients should be warned to avoid alcoholic beverages, as the combination of alcohol with this medication may exacerbate drowsiness. It is essential to inform patients that the use of alcohol, sedatives, and tranquilizers may further increase the drowsiness effect associated with the medication.

Storage and Handling

The product is supplied in a tightly sealed container to ensure integrity and stability. It should be stored in a dry place, maintaining a temperature below 25°C (77°F) and away from direct sunlight to preserve its efficacy. Proper storage conditions are essential for maintaining the quality 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 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 in the absence of noticeable signs or symptoms.

Drug Information (PDF)

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

View product document (PDF)