Tusslin

Description

No description information is available for the drug.

Uses and Indications

This drug is indicated for the temporary relief of cough associated with minor throat and bronchial irritation due to colds or inhaled irritants. It aids in loosening phlegm (mucus) and thinning bronchial secretions, facilitating drainage of the bronchial tubes and enhancing the productivity of coughs. Additionally, this drug provides temporary relief from nasal congestion resulting from colds.

Limitations of Use: This medication is intended for symptomatic relief and does not address the underlying causes of cough or nasal congestion.

Dosage and Administration

Adults and children aged 12 years and older are advised to administer 5 mL (1 teaspoon) every 4 hours as needed. It is imperative that no more than 6 doses are taken within a 24-hour period to avoid potential overdose.

The use of this medication is not recommended for children under 12 years of age. Healthcare professionals should ensure that patients are aware of the dosing limits and the importance of adhering to the recommended intervals.

Contraindications

There are no contraindications associated with the use of this product. It is deemed safe for use in the absence of specific conditions or situations that would warrant avoidance.

Warnings and Precautions

The use of this product is contraindicated in individuals currently taking prescription monoamine oxidase inhibitors (MAOIs), which are medications prescribed for depression, psychiatric or emotional conditions, or Parkinson’s disease. Additionally, it should not be used for a period of two weeks following the discontinuation of an MAOI. Healthcare professionals should advise patients to consult with a doctor or pharmacist if they are uncertain whether their prescription medication contains an MAOI.

Prior to using this product, it is essential for patients to seek medical advice if they have any of the following conditions: diabetes, heart disease, thyroid disease, high blood pressure, difficulty urinating due to an enlarged prostate gland, or a cough that is productive of excessive phlegm. Furthermore, patients with a chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema should also consult a healthcare professional.

Patients are advised to adhere strictly to the recommended dosage and not exceed the directed amount while using this product.

If any of the following symptoms occur, patients should discontinue use and consult a healthcare professional: feelings of nervousness, dizziness, or sleeplessness; if symptoms do not improve within seven days or are accompanied by fever; or if a cough persists for more than seven days, recurs, or is accompanied by fever, rash, or a persistent headache. These symptoms may indicate a more serious underlying condition.

For individuals who are pregnant or breastfeeding, it is crucial to seek guidance from a healthcare professional before using this product.

In the event of an overdose, immediate medical assistance should be sought, or contact with a Poison Control Center should be established without delay.

Side Effects

Patients should be aware of the potential adverse reactions associated with the use of this medication. Serious adverse reactions may occur, particularly in individuals with specific pre-existing conditions. It is contraindicated for patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within two weeks of discontinuing such treatment, as this may lead to severe interactions.

Patients with diabetes, heart disease, thyroid disease, high blood pressure, or those experiencing urinary difficulties due to an enlarged prostate gland should consult a healthcare professional before using this medication. Additionally, individuals with a cough that produces excessive phlegm or those with chronic cough conditions, such as smoking-related cough, asthma, chronic bronchitis, or emphysema, should seek medical advice prior to use.

Common adverse reactions may include nervousness, dizziness, or sleeplessness. Patients are advised to discontinue use and consult a healthcare provider if these symptoms occur. Furthermore, if symptoms do not improve within seven days or are accompanied by fever, or if a cough persists for more than seven days, recurs, or is associated with fever, rash, or a persistent headache, patients should seek medical attention, as these may indicate a serious underlying condition.

For pregnant or breastfeeding individuals, it is recommended to consult a health professional before using this medication to ensure safety for both the patient and the child.

Drug Interactions

The concomitant use of TUSSLIN with prescription monoamine oxidase inhibitors (MAOIs) is contraindicated. Patients should not take TUSSLIN while on MAOIs or for a period of two weeks following the discontinuation of an MAOI. This combination may result in serious interactions that could adversely affect patient health.

No additional drug or laboratory test interactions have been identified. Therefore, monitoring for potential adverse effects is advised when TUSSLIN is prescribed, particularly in patients with a history of MAOI use.

Packaging & NDC

Below are the non-prescription pack sizes of Tusslin (dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride). 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 5 mL (1 teaspoon) every 4 hours, with a maximum of 6 doses within a 24-hour period.

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.

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 regarding renal impairment, dosage adjustments, special monitoring, or safety considerations for patients with reduced kidney function. Healthcare professionals should exercise caution and consider individual patient factors when prescribing to patients with renal impairment, as the absence of detailed guidance necessitates careful clinical judgment.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the available information.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Prompt intervention is crucial to mitigate potential adverse effects associated with the overdose.

Healthcare professionals should be aware that the specific symptoms of an overdose may vary depending on the substance involved. Therefore, a thorough assessment of the patient's condition is essential to determine the appropriate course of action.

Management of an overdose typically involves supportive care and symptomatic treatment. Continuous monitoring of the patient's vital signs and clinical status is recommended. In cases where the specific substance is known, targeted therapies may be employed as indicated.

It is essential for healthcare providers to remain vigilant and act swiftly in the management of overdose situations to ensure optimal patient outcomes.

Nonclinical Toxicology

If pregnant or breast-feeding, it is advised to consult a health professional before use. No specific non-teratogenic effects have been identified in the available data. Additionally, there are no detailed findings regarding nonclinical toxicology or animal pharmacology and toxicology provided in the current information.

Postmarketing Experience

Serious side effects have been reported voluntarily through various channels, including surveillance programs. Healthcare professionals and patients are encouraged to report any serious adverse events to the designated phone number available for this purpose. Reports can be made on weekdays from 8:00 am to 4:00 pm AST.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. It is crucial to emphasize the importance of safety in the home environment, particularly for households with young children.

In the event of an overdose, healthcare providers should instruct patients to seek medical help immediately or contact a Poison Control Center. Patients should be made aware of the signs of overdose and the urgency of obtaining assistance to ensure their safety and well-being.

Storage and Handling

The product is supplied in packaging that includes a printed security seal. It is imperative that the product not be used if the security seal is torn, broken, or missing.

For optimal storage conditions, the product should be maintained at a controlled room temperature between 15-30ºC (59-86ºF). It is essential to avoid exposure to excessive heat or humidity to ensure the integrity and efficacy of the product.

Additional Clinical Information

The medication is administered orally. Clinicians should counsel patients to consult a health professional if they are pregnant or breastfeeding before use. It is important to keep the medication out of reach of children, and in the event of an overdose, patients should seek medical assistance or contact a Poison Control Center immediately. No additional information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

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

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