Tabcin Night

Description

NDC 69729-153-10. Tabcin NIGHT is a multi-symptom relief formulation indicated for the treatment of cough and flu symptoms. Each softgel contains a combination of acetaminophen, dextromethorphan HBr, and doxylamine succinate. The product is supplied in a package containing 10 softgels.

Uses and Indications

This drug is indicated for the temporary relief of symptoms associated with the common cold and influenza. Specifically, it alleviates cough due to minor throat and bronchial irritation, sore throat, headache, minor aches and pains, fever, as well as runny nose and sneezing.

There are no teratogenic or nonteratogenic effects mentioned in the available data.

Dosage and Administration

Patients should take the medication only as directed. The maximum allowable dosage is four doses within a 24-hour period.

For adults and children aged 12 years and older, the recommended dosage is two softgels taken with water every six hours.

For children aged 4 to under 12 years, it is advised to consult a physician for appropriate dosing recommendations.

The medication is not indicated for use in children under 4 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, is prohibited. If there is uncertainty regarding the presence of acetaminophen in a medication, consultation with a healthcare professional is advised.

• The product should not be used in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) for conditions such as depression, psychiatric or emotional disorders, or Parkinson's disease, nor within 2 weeks of discontinuing an MAOI. If there is uncertainty about whether a prescription medication contains an MAOI, a healthcare professional should be consulted prior to use.

Warnings and Precautions

This product contains acetaminophen, which poses a risk of severe liver damage if the following conditions are met: exceeding 4 doses within a 24-hour period, concurrent use with other medications containing acetaminophen, or consumption of 3 or more alcoholic beverages daily while using this product.

Acetaminophen may also lead to severe skin reactions, which can manifest as skin reddening, blisters, or 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 seek prompt medical attention if a sore throat is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting.

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

Patients should be instructed to stop taking the product and consult a physician if any of the following occur: pain or cough worsens or lasts longer than 7 days; fever worsens or persists for more than 3 days; redness or swelling is observed; cough recurs or is accompanied by a rash or headache that lasts; or if new symptoms develop. These may indicate a serious underlying condition.

No specific laboratory tests are recommended for the safe use of this product.

Side Effects

Severe liver damage may occur in patients who exceed the maximum daily dosage of four doses 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 that acetaminophen may lead to severe skin reactions, which can 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.

In cases where a sore throat is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, patients are advised to consult a physician promptly.

While using this product, excitability may occur, particularly in children, and marked drowsiness is also a potential side effect. Patients are cautioned to avoid alcoholic beverages, as well as sedatives and tranquilizers, which may exacerbate drowsiness. Care should be taken when driving a motor vehicle or operating machinery.

Patients should stop use and consult a doctor if pain or cough worsens or lasts longer than seven days, if fever worsens or persists for more than three days, if redness or swelling is observed, if a cough recurs or is accompanied by a rash or headache that lasts, or if new symptoms develop. These may indicate a serious condition.

It is critical to note that taking more than the directed dosage can lead to serious health complications. In the event of an overdose, patients should 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 apparent.

Drug Interactions

Concurrent use of this medication with any other drug containing acetaminophen, whether prescription or nonprescription, is contraindicated due to the risk of acetaminophen overdose.

The use of this medication is not recommended 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, and Parkinson's disease.

Patients should consult a healthcare professional prior to using this medication if they are concurrently taking sedatives or tranquilizers, as these substances may enhance the sedative effects.

Additionally, caution is advised for patients taking warfarin, an anticoagulant. It is recommended that individuals on warfarin seek guidance from a healthcare provider before using this medication to ensure safe co-administration.

The concomitant use of alcohol, sedatives, and tranquilizers with this medication may lead to increased drowsiness, necessitating careful monitoring of patients for excessive sedation.

Packaging & NDC

Below are the non-prescription pack sizes of Tabcin Night (acetaminophen, dextromethorphan hydrobromide, doxylamine succinate). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 4 to under 12 years should consult a healthcare professional before use. The product is not recommended for children under 4 years of age.

Caution is advised as excitability may occur, particularly in children. Additionally, marked drowsiness is a potential side effect that should be monitored. In the event of an overdose, it is critical to seek immediate medical attention for both adults and children, even if no signs or symptoms are apparent.

Geriatric Use

There is no specific geriatric use information provided in the prescribing information. Consequently, there are no recommended age considerations, dosage adjustments, safety concerns, or special precautions for elderly patients. Healthcare providers should exercise clinical judgment when prescribing this medication to geriatric patients, considering the individual health status and potential for altered pharmacokinetics in this population. Regular monitoring and assessment may be warranted to ensure safety and efficacy in elderly patients.

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 considered in these populations to ensure the safety of both the mother and the fetus or infant.

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 no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. 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.

Hepatic Impairment

Patients with hepatic impairment should exercise caution when using this product, which contains acetaminophen. Severe liver damage may occur if patients exceed the maximum daily dosage of 4 doses within a 24-hour period. Additionally, patients should avoid concomitant use with other medications containing acetaminophen, as this can further increase the risk of liver injury.

It is also advised that patients consuming three or more alcoholic drinks daily refrain from using this product, as alcohol can exacerbate the potential for liver damage.

Before initiating treatment, patients with known liver disease should consult a healthcare professional to assess the appropriateness of this product for their condition. Monitoring of liver function may be warranted in these patients to ensure safety and efficacy during treatment.

Overdosage

Taking more than the recommended dosage can lead to serious health complications. It is imperative that healthcare professionals remain vigilant regarding the potential risks associated with overdosage.

In the event of an overdose, immediate medical assistance should be sought. Healthcare providers are advised to contact a Poison Control Center without delay. Prompt intervention is crucial, as the severity of symptoms may not be immediately apparent.

For both adults and children, rapid medical attention is essential, even in the absence of noticeable signs or symptoms. This proactive approach can significantly mitigate the risks associated with overdosage and improve patient outcomes.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to use.

Excitability may occur, particularly in children, and marked drowsiness has been observed. The concomitant use of alcohol, sedatives, and tranquilizers may enhance drowsiness.

No specific information regarding nonclinical toxicology or animal pharmacology and toxicology is provided in the insert.

Postmarketing Experience

No postmarketing experience details are available for SPL code 90375-7.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. Patients should be instructed 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 be encouraged to consult a doctor or pharmacist.

It is important to inform patients that they should not use this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have stopped taking an MAOI within the last two weeks. Patients who are unsure if their prescription medication contains an MAOI should be advised to seek clarification from a healthcare professional.

Patients should be instructed to discontinue use and consult a doctor if their pain or cough worsens or persists for more than 7 days, if their fever worsens or lasts more than 3 days, or if they notice any redness or swelling. Additionally, they should seek medical advice if their cough returns or occurs alongside a rash or headache that lasts, or if they experience any new symptoms, as these may indicate a serious condition.

When using this product, patients should be made aware that excitability may occur, particularly in children, and that marked drowsiness is a possible side effect. They should be cautioned against consuming alcoholic beverages while using this product, as well as being careful when driving or operating machinery due to the potential for increased drowsiness. The use of alcohol, sedatives, and tranquilizers may further enhance drowsiness, and patients should be advised to consult a doctor or pharmacist if they are taking these substances.

Patients with liver disease, glaucoma, a cough that produces excessive phlegm, or breathing problems such as chronic cough, asthma, chronic bronchitis, or emphysema should be encouraged to seek medical advice before using this product. Additionally, those experiencing difficulty urinating due to an enlarged prostate gland, as well as patients taking sedatives, tranquilizers, or the anticoagulant warfarin, should also consult a healthcare professional prior to use.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers assigned for identification. It is essential to store the product at room temperature to maintain its integrity and efficacy. No special handling requirements are necessary beyond standard storage practices.

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. No further information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

Drug Information (PDF)

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

View product document (PDF)