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 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:

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. If there is uncertainty about a medication's MAOI content, a healthcare professional should be consulted.

This product is not recommended for children under 6 years of age unless specifically directed by a physician.

During use, 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. The risk of liver injury is heightened under the following circumstances: if an adult consumes more than 12 tablets within a 24-hour period, which is the maximum recommended daily dosage; if a child takes more than 5 doses in a 24-hour period; if the product is used concurrently with other medications containing acetaminophen; or if an adult consumes 3 or more alcoholic beverages daily while using this product.

It is imperative to avoid the concurrent use of this product with any other medications that contain acetaminophen, whether prescription or nonprescription. Healthcare professionals should advise patients to consult a doctor or pharmacist if there is uncertainty regarding the presence of acetaminophen in other medications.

Additionally, this product should not be used in conjunction with prescription monoamine oxidase inhibitors (MAOIs), which are commonly prescribed for depression, psychiatric or emotional conditions, or Parkinson’s disease. Patients should refrain from using this product for at least 2 weeks after discontinuing an MAOI. If there is any doubt regarding the presence of an MAOI in a prescription medication, patients should seek guidance from a healthcare professional.

In the event of an overdose, immediate medical assistance should be sought, or contact with a Poison Control Center is advised. Prompt medical attention is crucial for both adults and children, even if no signs or symptoms are initially apparent.

Patients should discontinue use and consult a healthcare provider if any of the following occur: worsening pain or nasal congestion lasting more than 5 days in children or 7 days in adults; persistent sore throat lasting more than 2 days; fever that worsens or lasts more than 3 days; nasal congestion accompanied by fever; symptoms of nervousness, dizziness, or sleeplessness; presence of redness or swelling; emergence of new symptoms; or any of the following serious signs: severe sore throat, sore throat accompanied or followed by fever, headache, rash, nausea, or vomiting.

Side Effects

Severe liver damage may occur in patients taking this product containing acetaminophen if they exceed the recommended dosage. Specifically, adults should not take more than 12 tablets in a 24-hour period, while children should not take more than 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 three or more alcoholic drinks daily while using this product.

Patients are advised to discontinue use 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; or if any of the following serious conditions are suspected: severe sore throat, sore throat accompanied or followed by fever, headache, rash, nausea, or vomiting.

Before using this product, patients should seek medical advice if they have a history of heart disease, high blood pressure, diabetes, glaucoma, liver disease, thyroid disease, high fever, or breathing problems such as emphysema or chronic bronchitis. Additionally, those experiencing difficulty in urination due to prostate gland enlargement should consult a healthcare provider.

Patients should also inform their doctor or pharmacist if they are currently taking tranquilizers, sedatives, or the blood-thinning medication warfarin, as these may interact with the product.

Drug Interactions

Co-administration of this drug with any other product containing acetaminophen is contraindicated due to the potential for increased risk of severe liver damage.

In addition, the concomitant use of acetaminophen and warfarin may elevate the risk of bleeding. It is recommended that the International Normalized Ratio (INR) be monitored closely in patients receiving both medications to ensure safe therapeutic levels are maintained.

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, with a maximum of 5 doses (5 tablets) in a 24-hour period, unless otherwise directed by a doctor.

Caution is advised, as severe liver damage may occur if a child exceeds 5 doses within 24 hours. Parents and caregivers are encouraged to consult a doctor for any child 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 adverse effects or changes in therapeutic response, 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 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 if the following conditions are met:

• An adult consumes more than 12 tablets within a 24-hour period, which is the maximum daily dosage for this product.

• A child takes more than 5 doses in a 24-hour period.

• The product is taken concurrently with other medications that contain acetaminophen.

• An adult consumes 3 or more alcoholic drinks daily while using this product.

Due to the potential for increased risk of liver damage, it is advisable for healthcare providers to assess liver function and consider dosage adjustments or alternative therapies for patients with compromised liver function. Regular monitoring of liver enzymes may be warranted in these patients to ensure safety and efficacy.

Overdosage

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

Adult Overdosage An adult who ingests more than 12 tablets within a 24-hour period is at risk of experiencing severe liver damage. This threshold represents the maximum daily dosage for this product. Additionally, concurrent use of this product with other medications containing acetaminophen can exacerbate the risk of liver injury. Furthermore, adults who consume three or more alcoholic beverages daily while using this product may also face severe liver damage.

Pediatric Overdosage For children, the risk of severe liver damage arises if more than 5 doses are taken within a 24-hour timeframe. Careful monitoring of dosage is essential to prevent potential harm.

Recommended Actions Healthcare professionals should be vigilant in assessing patients for signs of liver damage in cases of suspected overdosage. Immediate medical intervention is advised, and appropriate management procedures should be initiated based on the severity of the symptoms presented.

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 alcohol, sedatives, or tranquilizers may enhance this effect. Additionally, excitability may occur, particularly in children.

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. Users are encouraged to report any such events to the appropriate authorities.

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 initially 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 their healthcare provider 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 healthcare provider if they experience nervousness, dizziness, sleeplessness, redness, swelling, or any new symptoms.

Healthcare providers should emphasize the importance of seeking medical attention if patients experience severe sore throat, especially if accompanied or followed by fever, headache, rash, nausea, or vomiting. This product should not be administered to children under 6 years of age unless directed by a doctor.

Patients must be reminded not to exceed the recommended dosage while using this product. They should be made aware that it may cause excitability, particularly in children, and that caution is advised when driving or operating machinery. Patients should also avoid alcoholic beverages while using this product, as it may cause drowsiness, which can be exacerbated by alcohol, sedatives, and tranquilizers.

Healthcare providers should encourage patients to consult a doctor before using this product 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 be advised to speak with 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. Proper storage conditions are essential to preserve the product's efficacy and safety.

Additional Clinical Information

The product 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 product 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.

Additionally, patients and healthcare providers are encouraged to report any serious adverse events associated with the use of this product.

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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