Coltalin-Dm

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, headache, sore throat, nasal congestion, runny nose, sinus congestion and pressure, cough due to minor throat and bronchial irritation, as well as sneezing, itching of the nose or throat, and itchy, watery eyes due to 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, equating to 12 tablets in 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 for this age group should not exceed 5 doses, which corresponds to 5 tablets in 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, due to the risk of acetaminophen overdose. If uncertain about the presence of acetaminophen in other medications, 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 advice from a healthcare professional.

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

Additionally, while using this product, it is essential to adhere to the recommended dosage, refrain from driving or operating machinery, and avoid the consumption of alcoholic beverages.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen, under the following circumstances: if an adult takes 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 drinks daily while using this product.

It is imperative to avoid the concurrent use of this product with any other drug containing 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 by individuals currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such medication. Patients should be encouraged to seek clarification from a healthcare provider if they are unsure whether their prescription includes an MAOI.

Patients should be instructed 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; nasal congestion is accompanied by fever; symptoms of nervousness, dizziness, or sleeplessness arise; or if any of the following serious conditions develop: fever worsens or lasts more than 3 days; severe sore throat; sore throat accompanied or followed by fever, headache, rash, nausea, or vomiting; presence of redness or swelling; new symptoms emerge; or cough persists for more than 1 week, recurs, or is accompanied by fever, rash, or persistent headache.

In the event of an overdose, it is crucial to seek emergency medical assistance or contact a Poison Control Center immediately. Prompt medical attention is essential for both adults and children, even if no signs or symptoms are initially apparent.

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 exceed 5 doses in the same timeframe. The risk of liver damage is heightened if the product is taken concurrently 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 pain or nasal congestion worsens or persists beyond 5 days in children or 7 days in adults. Additionally, a sore throat that lasts more than 2 days, nasal congestion accompanied by fever, or the occurrence of nervousness, dizziness, or sleeplessness warrants medical attention. Serious conditions may be indicated by symptoms such as a worsening fever lasting more than 3 days, severe sore throat, sore throat accompanied by fever, headache, rash, nausea, or vomiting, as well as the presence of redness or swelling. Patients should also seek medical advice if new symptoms arise or if a cough persists for more than 1 week, particularly if it recurs or is accompanied by fever, rash, or persistent headache.

Before using this product, patients with certain pre-existing conditions should consult a healthcare provider. These conditions include heart disease, high blood pressure, diabetes, glaucoma, liver disease, thyroid disease, high fever, breathing problems such as emphysema or chronic bronchitis, difficulty urinating due to prostate enlargement, or a persistent cough. Furthermore, patients taking sedatives, tranquilizers, or the blood-thinning medication warfarin should seek guidance from a doctor or pharmacist prior to use.

Drug Interactions

Co-administration of acetaminophen with other products containing acetaminophen is contraindicated due to the increased risk of severe liver damage. Healthcare professionals should advise patients to avoid using multiple acetaminophen-containing medications simultaneously.

When chlorpheniramine maleate is taken in conjunction with sedatives or tranquilizers, there is a potential for enhanced drowsiness. Patients should be cautioned about this interaction and advised to avoid activities that require full alertness, such as driving or operating heavy machinery, until they are aware of how the combination affects them.

Additionally, the use of acetaminophen may influence warfarin levels, necessitating close monitoring of the International Normalized Ratio (INR). It is recommended that healthcare providers assess INR more frequently when initiating or discontinuing acetaminophen therapy in patients on warfarin.

Packaging & NDC

Below are the non-prescription pack sizes of Coltalin-Dm (acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide, 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 1 tablet every 4 hours as needed, not to exceed 5 doses (5 tablets) in a 24-hour period, or as directed by a physician. In adolescents aged 12 years and older, the dosage is 2 tablets every 4 hours as needed, with a maximum of 6 doses (12 tablets) in 24 hours, or as directed by a healthcare provider.

Caution is advised, as severe liver damage may occur if a child exceeds 5 doses in 24 hours. Additionally, this medication may cause excitability, particularly in pediatric patients. If pain or nasal congestion worsens or persists for more than 5 days, parents or caregivers should discontinue use and consult a doctor.

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 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 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 exercise caution when using this product, as it contains acetaminophen, which is associated with the risk of severe liver damage. The maximum recommended dosage for adults is 12 tablets in a 24-hour period. Exceeding this limit may lead to significant hepatic injury, particularly in individuals with compromised liver function.

For pediatric patients, it is critical to adhere to the dosing guidelines, which stipulate that no more than 5 doses should be administered within a 24-hour period. Careful monitoring of both adult and pediatric patients is advised, especially in those who may be taking other medications containing acetaminophen, as this can further increase the risk of liver damage.

Additionally, adults who consume 3 or more alcoholic drinks daily should avoid using this product, as the combination of alcohol and acetaminophen can exacerbate the potential for liver injury. Regular assessment of liver function may be warranted in patients with hepatic impairment to ensure safe use of this medication.

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 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 Risks For children, the risk of severe liver damage arises if more than five doses are taken within a 24-hour timeframe.

Healthcare professionals should remain vigilant for signs of liver damage in both adults and children who exceed these dosage recommendations. Immediate medical evaluation and intervention are advised in cases of suspected overdosage.

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, and can lead to significant drowsiness. The sedative effects may be exacerbated by the concurrent use of alcohol, sedatives, or 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 to prevent accidental ingestion. In the event of an overdose, it is crucial for patients 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 that this medication should not be given to children under 6 years of age unless specifically directed by a doctor. When using this product, it is important to adhere to the recommended dosage and to be aware that it may cause excitability, particularly in children. Patients should be cautioned against driving or operating machinery while using this medication, as it may cause marked drowsiness. Additionally, patients should avoid consuming alcoholic beverages, as alcohol, sedatives, and tranquilizers can enhance the drowsiness effect.

Healthcare providers should encourage patients 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, difficulty urinating due to an enlarged prostate gland, or a persistent cough. Furthermore, patients should be advised to speak with a doctor or pharmacist before using this medication if they are currently taking sedatives or tranquilizers, or the blood-thinning medication warfarin.

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 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 if no signs or symptoms are apparent.

Drug Information (PDF)

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

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