Tabcin

Description

No description information is available for the drug.

Uses and Indications

This drug is indicated for the temporary relief of symptoms associated with the common cold and influenza. Specifically, it addresses the following symptoms: runny nose, sneezing, cough due to minor bronchial irritation, nasal congestion, minor aches and pains, headache, sore throat, and fever reduction.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Adults and children aged 12 years and older are advised to take 2 softgels with water every 4 hours as needed. The maximum dosage should not exceed 10 softgels within a 24-hour period, unless otherwise directed by a healthcare professional.

The use of this medication is not recommended for children under 12 years of age.

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 there is uncertainty regarding the presence of acetaminophen in other medications, consultation with a healthcare professional is advised.

• Concurrent use with prescription monoamine oxidase inhibitors (MAOIs) or within 2 weeks of discontinuing an MAOI. This includes certain medications prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease, as the combination may lead to serious adverse effects. If there is uncertainty about the presence of an MAOI in a prescription medication, a healthcare professional should be consulted.

• Exceeding the recommended dosage is contraindicated to prevent potential toxicity.

• Consumption of alcoholic beverages while taking this product is contraindicated due to the increased risk of liver damage and other adverse effects.

Warnings and Precautions

This product contains acetaminophen, which poses a risk of severe liver damage if the following conditions are met: exceeding 10 softgels within a 24-hour period, concurrent use with other medications containing acetaminophen, or consumption of three or more alcoholic drinks daily while using this product.

Acetaminophen may also lead to severe skin reactions, characterized by symptoms such as skin reddening, blisters, and rash. In the event of a skin reaction, it is imperative to discontinue use immediately and seek medical assistance.

Healthcare professionals should advise patients to consult a doctor prior to use if they have any of the following conditions: liver disease, heart disease, high blood pressure, thyroid disease, diabetes, glaucoma, or respiratory issues such as emphysema or chronic bronchitis. Additionally, patients experiencing difficulty urinating due to prostate enlargement or those with a persistent or chronic cough, particularly if associated with smoking, asthma, or excessive phlegm, should also seek medical advice before use.

Patients should be cautioned to consult a doctor or pharmacist if they are currently taking blood thinners such as warfarin or sedatives and tranquilizers, as these may interact with the product.

In the event of an overdose, immediate medical attention is crucial. Patients should contact a Poison Control Center or seek emergency medical help without delay, regardless of the presence of symptoms.

Patients are advised to discontinue use and contact a healthcare provider if they experience nervousness, dizziness, or sleeplessness; if pain or cough worsens or persists beyond 7 days; if fever worsens or lasts more than 3 days; if redness or swelling occurs; if new symptoms arise; or if a cough recurs alongside a rash or headache lasting longer than expected. These symptoms may indicate a serious underlying condition that requires further evaluation.

Side Effects

Severe liver damage may occur in patients who exceed the maximum daily dosage of 10 softgels within a 24-hour period, take the product in conjunction with other medications containing acetaminophen, or consume three or more alcoholic drinks daily while using this product.

Patients should be aware of the potential for severe skin reactions associated with acetaminophen, which may manifest as skin reddening, blisters, or rash. In the event of a skin reaction, it is imperative to discontinue use and seek medical assistance immediately. Additionally, if a sore throat is severe, persists for more than two days, and is accompanied or followed by fever, headache, rash, nausea, or vomiting, patients are advised to consult a healthcare professional promptly.

Participants in clinical trials and postmarketing experiences have reported various adverse reactions. Patients should stop use and consult a doctor if they experience nervousness, dizziness, or sleeplessness; if pain or cough worsens or lasts longer than seven days; if fever worsens or persists beyond three days; if redness or swelling occurs; if new symptoms arise; or if a cough recurs or is accompanied by a rash or headache that lasts. These symptoms may indicate a serious condition.

While using this product, patients may experience excitability, particularly in children, and drowsiness, which may be exacerbated by alcohol, sedatives, or tranquilizers. Caution is advised when driving a motor vehicle or operating machinery.

Patients with pre-existing conditions such as liver disease, heart disease, high blood pressure, thyroid disease, diabetes, glaucoma, or breathing problems (e.g., emphysema or chronic bronchitis) should consult a doctor before use. Additionally, those experiencing difficulty urinating due to prostate enlargement or persistent coughs associated with smoking, asthma, or emphysema should seek medical advice unless directed otherwise.

Patients taking blood-thinning medications such as warfarin or those on sedatives or tranquilizers should consult a doctor or pharmacist prior to use. In the event of an overdose, immediate medical attention is critical for both adults and children, even if no signs or symptoms are initially apparent.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there are no known 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 Tabcin (acetaminophen, chlorpheniramine maleate, dextromethorphan hbr, phenylephrine hcl,). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should not use this medication. For adolescents aged 12 years and older, the recommended dosage is 2 softgels taken with water every 4 hours, with a maximum of 10 softgels in a 24-hour period, unless otherwise directed by a healthcare professional.

Caution is advised as the medication may cause excitability, particularly in children. In the event of an overdose, it is essential to seek prompt medical attention for both adults and pediatric patients, even if no signs or symptoms are immediately apparent.

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. 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 currently no available data on the excretion of this drug in human 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 drug insert regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients, although specific recommendations are not provided.

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. It is critical that patients do not exceed the maximum daily dosage of 10 softgels within a 24-hour period. Additionally, patients should avoid concurrent use with other medications that contain acetaminophen, as this may further increase the risk of liver injury.

Patients with compromised liver function are advised to consult a healthcare professional prior to using this product, particularly if they have a history of liver disease. Furthermore, consumption of three or more alcoholic drinks per day while using this product is strongly discouraged, as it may exacerbate the risk of liver damage. Regular monitoring of liver function may be warranted in patients with existing liver conditions to ensure safety and efficacy during treatment.

Overdosage

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

Healthcare professionals should be aware that the lack of immediate symptoms does not preclude the potential for serious health consequences. Therefore, it is essential to monitor the patient closely and provide appropriate care as needed.

Nonclinical Toxicology

There is currently no available information regarding teratogenic or non-teratogenic effects associated with the compound. Additionally, no data has been provided concerning nonclinical toxicology, including animal pharmacology and toxicology.

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 reaction, it is advised to discontinue use immediately and seek medical assistance.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center in the event of an overdose, 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 about the presence of acetaminophen in their medications, they should be encouraged to 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 advised to check with their healthcare provider if they are unsure whether their prescription includes an MAOI.

Patients should be counseled to discontinue use and consult a doctor if they experience nervousness, dizziness, or sleeplessness. Additionally, they should be advised to stop use and seek medical advice if their pain or cough worsens or persists for more than seven days, if fever worsens or lasts more than three days, if redness or swelling occurs, or if new symptoms develop. They should also be informed to seek medical attention if a cough recurs or is accompanied by a rash or persistent headache, as these may indicate a serious condition.

While using this product, patients should be cautioned against exceeding the recommended dosage. They should be made aware that the product may cause excitability, particularly in children, and may also lead to drowsiness. Patients should be advised to avoid alcoholic beverages, as alcohol, sedatives, and tranquilizers can enhance the drowsiness effect. Caution should be exercised when driving or operating machinery.

Patients with specific health conditions should be encouraged to consult their healthcare provider before using this product. These conditions include liver disease, heart disease, high blood pressure, thyroid disease, diabetes, glaucoma, breathing problems such as emphysema or chronic bronchitis, difficulty urinating due to prostate gland enlargement, and persistent or chronic coughs associated with smoking, asthma, or excessive phlegm. Furthermore, patients should be advised to consult a doctor or pharmacist if they are taking the blood-thinning medication warfarin or any sedatives or tranquilizers.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It should be stored at room temperature, within the range of 15° to 30°C (59°F to 86°F). Care should be taken to avoid exposure to excessive heat, ensuring the integrity of the product is maintained throughout its storage period.

Additional Clinical Information

The medication is administered orally. For adults and children aged 12 years and older, the recommended dosage is 2 softgels taken with water every 4 hours, with a maximum of 10 softgels in a 24-hour period unless otherwise directed by a healthcare professional. Use is not recommended for children under 12 years of age.

Clinicians should counsel patients to consult a health professional if they are pregnant or breastfeeding. It is essential to keep the medication out of reach of children. In the event of an overdose, immediate medical assistance should be sought, and contacting a Poison Control Center is advised, as prompt attention is critical for both adults and children, even in the absence of noticeable symptoms.

Drug Information (PDF)

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

View product document (PDF)