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

Adults and children 12 years of age and older are instructed to take 2 tablets every 4 hours as needed while symptoms persist. The total dosage must 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 provider.

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, due to the risk of acetaminophen overdose. If uncertain about the presence of acetaminophen in a medication, consult a healthcare professional.

• Concurrent use with prescription monoamine oxidase inhibitors (MAOIs) 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, seek guidance from a healthcare professional.

• Administration to children under 6 years of age is contraindicated unless specifically directed by a physician.

• Exceeding the recommended dosage is contraindicated to prevent potential adverse effects.

• Consumption of alcoholic beverages while using this product is contraindicated due to the risk of increased side effects.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen, under the following circumstances: if an adult consumes more than 12 tablets within a 24-hour period, if a child takes more than 5 doses in 24 hours, if it is taken 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 they are uncertain whether a medication contains acetaminophen.

Additionally, this product should not be used in conjunction with any 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 uncertainty regarding the presence of an MAOI in a prescription medication, patients should seek guidance from a healthcare professional.

Patients are advised to discontinue use and consult a doctor 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.

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 if no signs or symptoms are immediately apparent.

Side Effects

Patients using this product should be aware of potential adverse reactions, particularly concerning liver health. The product contains acetaminophen, and severe liver damage may occur if an adult takes more than 12 tablets in a 24-hour period, which is the maximum daily amount. Additionally, children should not take more than 5 doses in 24 hours, and caution is advised if the product is taken alongside other medications containing acetaminophen. Adults who consume three or more alcoholic drinks daily while using this product are also at increased risk for liver damage.

Patients are advised to stop use and consult a doctor if certain symptoms occur. These include worsening pain or nasal congestion lasting more than 5 days in children or 7 days in adults, a sore throat persisting for more than 2 days, fever that worsens or lasts more than 3 days, nasal congestion accompanied by fever, or the emergence of nervousness, dizziness, or sleeplessness. Redness or swelling, new symptoms, or any of the following serious conditions warrant immediate medical attention: severe sore throat, sore throat accompanied or followed by fever, headache, rash, nausea, or vomiting.

Before using this product, patients should consult a doctor 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. Those experiencing difficulty in urination due to an enlarged prostate gland should also seek medical advice prior to use.

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

Drug Interactions

Co-administration of this product with any other medication containing acetaminophen is contraindicated due to the potential for increased risk of severe liver damage. Healthcare professionals should ensure that patients are not using multiple acetaminophen-containing products concurrently.

Additionally, the use of this product in conjunction with warfarin, an anticoagulant, may elevate the risk of bleeding complications. It is advisable to monitor patients closely for signs of increased bleeding and to consider dosage adjustments of warfarin as necessary based on clinical judgment and patient response.

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 be given this medication unless directed by a doctor. For children aged 6 to under 12 years, the recommended dosage is 1 tablet every 4 hours as needed, not to exceed 5 doses (5 tablets) in a 24-hour period, unless otherwise directed by a healthcare professional.

Caution is advised, as severe liver damage may occur if a child exceeds the maximum dosage of 5 doses in 24 hours. Parents and caregivers are encouraged to consult a doctor for any child under 6 years of age before administration.

Geriatric Use

There is no specific information available 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 individual responses may vary. It is advisable to monitor these patients closely for any 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 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 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 be closely monitored when using this product, which contains acetaminophen. 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 recommended that patients with compromised liver function adhere strictly to the prescribed dosage and avoid concurrent use of other acetaminophen-containing products. Regular monitoring of liver function may be warranted in these patients to prevent adverse effects.

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. This risk is further compounded if the individual consumes three or more alcoholic beverages daily while using this product, as alcohol can exacerbate the hepatotoxic effects of acetaminophen.

Pediatric Overdosage Risks For children, the threshold for potential severe liver damage is lower; ingestion of more than five doses within a 24-hour timeframe may lead to similar hepatic complications.

Drug Interactions The concomitant use of this product with other medications containing acetaminophen significantly increases the risk of severe liver damage. Healthcare professionals should be vigilant in assessing a patient's complete medication history to prevent such interactions.

Recommended Actions In the event of suspected overdosage, immediate medical attention is warranted. Healthcare providers should initiate appropriate management procedures, which may include monitoring liver function and considering the administration of N-acetylcysteine as an antidote, depending on the severity of the situation and the time elapsed since ingestion.

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

Serious side effects have been reported voluntarily or through surveillance programs. Healthcare professionals and patients are encouraged to report any adverse events to the designated phone number for further evaluation and monitoring.

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 present.

Patients should be informed not to use this product in conjunction with any other medications containing acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in other medications, patients should consult a doctor or pharmacist.

It is important to instruct patients not to use this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have stopped taking an MAOI within the past two weeks. Patients should be encouraged to ask a healthcare professional if they are unsure whether their prescription medication contains an MAOI.

Patients should be advised 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. Additionally, they should 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. Patients should also be instructed to stop use and consult a doctor if they experience nervousness, dizziness, sleeplessness, redness, swelling, or if new symptoms arise.

Healthcare providers should inform patients of the signs of serious conditions, such as severe sore throat, sore throat accompanied by fever, headache, rash, nausea, or vomiting, and advise them to seek medical attention if these occur.

Patients should be cautioned against administering this product to children under 6 years of age unless directed by a doctor. They should be reminded to adhere to the recommended dosage and to be aware that the product may cause excitability, particularly in children.

When using this product, patients should exercise caution when driving or operating machinery and avoid alcoholic beverages. It may cause drowsiness, and the effects can be intensified by alcohol, sedatives, or tranquilizers.

Patients should be encouraged to consult a doctor before use if they have any of the following conditions: heart disease, high blood pressure, diabetes, glaucoma, liver disease, thyroid disease, a high fever, breathing problems such as emphysema or chronic bronchitis, or difficulty urinating due to prostate gland enlargement. Furthermore, 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 away from direct sunlight to preserve its efficacy. Proper handling and storage conditions are essential to maintain the quality of the product.

Additional Clinical Information

No further data are available.

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.

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