Extra Fast 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 older, 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 while symptoms persist, with a maximum of 5 doses (5 tablets) in a 24-hour period, or as 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:

Co-administration with any other drug containing acetaminophen, whether prescription or nonprescription, is prohibited due to the risk of acetaminophen overdose. If there is uncertainty regarding the presence of acetaminophen in other medications, consultation with a healthcare professional is advised.

The product should not be used in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such treatment. MAOIs are commonly prescribed for depression, psychiatric or emotional conditions, or Parkinson’s disease. Verification of the presence of an MAOI in any prescription medication should be conducted with a healthcare professional prior to use.

Additionally, while using this product, it is essential to adhere to the recommended dosage and to avoid the consumption of alcoholic beverages.

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 within a 24-hour period, as this is the maximum daily dosage.

• For children, the maximum is 5 doses in a 24-hour period.

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

• Patients who consume three or more alcoholic beverages daily should be closely monitored, as this increases the risk of 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 In the event of an overdose, it is crucial to obtain medical help or contact a Poison Control Center without delay. Prompt medical intervention is essential for both adults and children, even in the absence of noticeable signs or symptoms.

Emergency Medical Help In cases of overdose, immediate medical attention is necessary. Healthcare providers should ensure that patients are aware of the importance of seeking help promptly.

Monitoring and Follow-Up Patients should be advised to stop taking the product and consult a healthcare professional if any of the following occur:

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

• 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 these parameters to ensure patient safety and effective management of potential adverse effects.

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 within 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 three 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, it is imperative to discontinue use and seek medical assistance immediately.

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 Extra Fast 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, not to exceed 5 tablets in a 24-hour period, unless otherwise directed by a doctor.

Caution is advised as the medication may cause excitability, particularly in children. Parents and caregivers should monitor for worsening pain or nasal congestion; if symptoms persist beyond 5 days, they should discontinue use and consult a healthcare provider.

Geriatric Use

There is no specific information 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 they may have altered pharmacokinetics and pharmacodynamics. Monitoring for potential adverse effects and therapeutic efficacy is recommended in 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 safe use during pregnancy and lactation.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is no specific data available regarding the excretion of this medication in 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 should be closely monitored when using this product, which contains acetaminophen. It is critical to note that severe liver damage may occur under certain conditions.

For adults, the maximum daily dosage should not exceed 12 tablets within a 24-hour period. In pediatric patients, the maximum is limited to 5 doses in a 24-hour period. Additionally, patients must be cautioned against the concurrent use of other medications containing acetaminophen, as this can significantly increase the risk of liver damage.

Furthermore, patients with a history of alcohol consumption should be advised that the risk of liver injury is heightened if they consume 3 or more alcoholic drinks daily while using this product. Given these considerations, healthcare providers should evaluate liver function and consider dosage adjustments or alternative therapies for patients with compromised liver function to mitigate the risk of hepatotoxicity.

Overdosage

In cases of overdosage, significant health risks are associated with the consumption of this product beyond the recommended limits.

Adult Overdosage Risks An adult who ingests more than 12 tablets within a 24-hour period, which exceeds the maximum daily dosage, is at risk of experiencing severe liver damage. Additionally, concurrent use of this product with other medications containing acetaminophen can exacerbate the risk of liver injury. It is also important to note that adults who consume three or more alcoholic beverages daily while using this product may further increase their susceptibility to severe liver damage.

Pediatric Overdosage Risks For children, the threshold for potential severe liver damage is lower; ingestion of more than 5 doses within a 24-hour timeframe poses a significant risk.

Recommended Actions Healthcare professionals should be vigilant in assessing patients for signs of liver damage in cases of suspected overdosage. Immediate medical evaluation is advised, and appropriate management should be initiated based on the severity of the symptoms and the amount ingested. Monitoring liver function tests and providing supportive care are critical components of the management strategy in these situations.

Nonclinical Toxicology

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

The substance may induce excitability, particularly in children. Additionally, it may lead to drowsiness, which can be exacerbated by the concurrent use of alcohol, sedatives, and tranquilizers.

No specific information regarding nonclinical toxicology or animal pharmacology and toxicology is available in the insert.

Postmarketing Experience

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

Patient Counseling

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

Patients should be informed not to use this product in conjunction with any other medications containing acetaminophen, whether prescription or nonprescription. If patients are uncertain whether a drug contains acetaminophen, they should consult a doctor or pharmacist for clarification. Additionally, this product should not be used by individuals currently taking a prescription monoamine oxidase inhibitor (MAOI) or within two weeks of stopping such medication. Patients should be encouraged to ask a healthcare professional if they are unsure whether their prescription includes an MAOI.

Patients should be instructed to discontinue use and consult a doctor if their pain or nasal congestion worsens or persists beyond 5 days for children or 7 days for adults. They should also seek medical advice if a sore throat lasts more than 2 days, if a fever worsens or lasts more than 3 days, or if nasal congestion is accompanied by fever. Furthermore, patients should stop use and contact a doctor if they experience nervousness, dizziness, sleeplessness, redness, swelling, or any new symptoms.

Healthcare providers should emphasize the importance of recognizing serious conditions, advising patients to seek medical attention if they experience severe sore throat, sore throat accompanied or followed by fever, headache, rash, nausea, or vomiting. Patients must be reminded not to exceed the recommended dosage while using this product.

It is important to inform patients that this medication may cause excitability, particularly in children, and to exercise caution when driving or operating machinery. Patients should also be advised to avoid alcoholic beverages while using this product, as it may cause drowsiness, which can be exacerbated by alcohol, sedatives, and tranquilizers.

Before using this product, patients should consult a doctor if they have any of the following conditions: heart disease, high blood pressure, diabetes, glaucoma, liver disease, thyroid disease, high fever, breathing problems such as emphysema or chronic bronchitis, or difficulty urinating due to prostate gland enlargement. Additionally, patients should seek advice from a doctor or pharmacist if they are taking tranquilizers, sedatives, or the blood-thinning medication warfarin.

Storage and Handling

The product is supplied in a tightly sealed container to ensure its integrity. It should be stored in a dry place, maintaining a temperature below 25°C (77°F) and protected from direct sunlight to preserve its efficacy. Proper handling and storage conditions are essential to maintain 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 Extra Fast Coltalin, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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