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. These symptoms include 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 (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:

The product should not be used in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in a medication, consultation with a healthcare professional is advised.

Additionally, the product is contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such treatment. MAOIs are typically prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. If there is any doubt about the presence of an MAOI in a prescription medication, a healthcare professional should be consulted prior to use.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen. Healthcare professionals should advise patients that the risk of liver injury increases significantly if an adult exceeds 12 tablets within a 24-hour period, which is the maximum recommended dosage. For children, the risk escalates if more than 5 doses are taken in a 24-hour timeframe. Additionally, caution is warranted when this product is used concurrently with other medications containing acetaminophen. Patients who consume three or more alcoholic beverages daily while using this product are also at an increased risk for liver damage.

Acetaminophen may induce severe skin reactions, which necessitates an allergy alert. Symptoms indicative of such reactions include skin reddening, blisters, and rash. Should any of these symptoms manifest, patients must discontinue use immediately and seek medical assistance.

In the event of an overdose, it is imperative to obtain emergency medical help or contact a Poison Control Center without delay. Prompt medical intervention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Patients should be instructed to cease use and consult a healthcare provider if any of the following conditions arise: worsening pain or nasal congestion lasting beyond 5 days in children or 7 days in adults; a sore throat persisting for more than 2 days; nasal congestion accompanied by fever; or the onset of nervousness, dizziness, or sleeplessness. Furthermore, patients should be vigilant for signs of serious conditions, which warrant immediate medical attention. These include: a fever that worsens or lasts more than 3 days; a severe sore throat; a sore throat accompanied or followed by fever, headache, rash, nausea, or vomiting; the presence of redness or swelling; the emergence of new symptoms; or a cough that persists for more than 1 week, recurs, or is accompanied by fever, rash, or a persistent headache.

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 further 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, nasal congestion accompanied by fever, and the onset of nervousness, dizziness, or sleeplessness. Patients should also seek medical advice if they experience any of the following, which may indicate a serious condition: worsening fever lasting 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, or a cough that persists for more than 1 week, recurs, or is accompanied by fever, rash, or persistent headache.

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-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 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 require specific dosage adjustments or exhibit unique safety concerns based on the available data. However, it is essential for healthcare providers to exercise caution when prescribing this product to geriatric patients, particularly those with pre-existing medical conditions.

Patients aged 65 and older should be advised to consult a healthcare professional prior to use if they have any of the following conditions: heart disease, high blood pressure, diabetes, glaucoma, liver disease, thyroid disease, a high fever, respiratory issues such as emphysema or chronic bronchitis, a persistent cough, cough with excessive phlegm, or difficulty urinating due to prostate enlargement.

Additionally, the product may induce marked drowsiness, which could be exacerbated by the concurrent use of alcohol, sedatives, or tranquilizers. This heightened drowsiness effect is particularly pertinent for elderly patients, who may be more susceptible to such side effects.

Furthermore, it is advisable for geriatric patients to consult a doctor or pharmacist before using this product if they are concurrently taking sedatives, tranquilizers, or anticoagulants such as warfarin. Monitoring and careful consideration of these factors are recommended to ensure the safe use of the product in the elderly 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 the safety of both the mother and the developing fetus or nursing 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 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 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 to ensure patient safety.

Overdosage

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

Adult Overdosage An adult who ingests more than 12 tablets within a 24-hour period is at risk of experiencing severe liver damage. It is crucial for healthcare professionals to monitor liver function and assess the patient for any signs of hepatic impairment.

Pediatric Overdosage For children, the threshold for potential severe liver damage is exceeded if more than 5 doses are taken within a 24-hour period. Healthcare providers should be vigilant in evaluating the child’s condition and liver function, as well as providing appropriate interventions.

Recommended Actions In the event of suspected overdosage, immediate medical attention is warranted. Healthcare professionals should initiate supportive care and consider the need for further diagnostic evaluation to assess liver function. It is essential to educate patients and caregivers about the importance of adhering to the recommended dosage to prevent such adverse effects.

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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

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 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 patients are uncertain whether a drug contains acetaminophen, they 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 their healthcare provider or pharmacist 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 nasal congestion is accompanied by fever, or if they experience nervousness, dizziness, or sleeplessness.

Healthcare providers should inform patients to stop using the product and consult a doctor if any of the following occur, as these may indicate a serious condition: worsening fever lasting 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, or a cough that persists for more than 1 week, recurs, or is accompanied by fever, rash, or persistent headache.

Patients should be reminded not to exceed the recommended dosage while using this product. They should also be made aware that the medication may cause excitability, particularly in children, and that they should avoid driving or operating machinery while using it. Alcoholic beverages should be avoided, as the product may cause marked 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, a persistent cough, cough with excessive phlegm, or difficulty urinating due to prostate gland enlargement. Furthermore, patients should seek advice from a doctor or pharmacist if they are taking sedatives, tranquilizers, 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 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-Dm, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)