Tussin Long Acting Cough

Description

Dextromethorphan HBr is a cough suppressant formulated to provide relief from coughing for up to 8 hours. Each dosage contains 30 mg of Dextromethorphan HBr and is intended for use in individuals aged 12 years and older. The formulation includes 1.4% alcohol and is designed to be non-drowsy. A dosing cup is included with the product for accurate administration. This product is manufactured by PL Developments, located at 11865 S. Alamea St, Lynwood, CA 90262.

Uses and Indications

This drug is indicated for the temporary relief of cough associated with minor throat and bronchial irritation, which may occur due to a cold.

Limitations of Use: This medication is intended for short-term use and should not be used for persistent or chronic coughs without consulting a healthcare professional.

Dosage and Administration

Adults and children aged 12 years and older are advised to take 10 mL every 6 to 8 hours as needed. It is imperative that no more than 4 doses are administered within a 24-hour period. The dosing should be measured exclusively with the dosing cup provided with the product; the use of any other dosing device is not recommended. The dosing cup should be kept with the product to ensure accurate measurement.

This product is not intended for use in children under 12 years of age.

Contraindications

Use of this product is contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications for depression, psychiatric or emotional conditions, or Parkinson’s disease. Additionally, use is contraindicated for a period of 2 weeks following the discontinuation of an MAOI. Patients should consult a healthcare professional if uncertain whether their prescription medication contains an MAOI.

Warnings and Precautions

It is imperative to adhere to the following warnings and precautions to ensure the safe use of this product.

Warnings The use of this product is contraindicated in individuals currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications prescribed for depression, psychiatric or emotional conditions, or Parkinson’s disease. Additionally, this product 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 there is uncertainty regarding the presence of an MAOI in their prescription medications.

General Precautions Prior to using this product, patients should seek medical advice if they are experiencing a cough that is associated with excessive phlegm (mucus) or if they have a chronic cough, which may be indicative of underlying conditions such as smoking, asthma, or emphysema.

Stop Taking and Call Your Doctor Instructions Patients are advised to discontinue use and consult a healthcare provider if their cough persists for more than seven days, recurs, or is accompanied by additional symptoms such as fever, rash, or a persistent headache. These symptoms may indicate a serious medical condition that requires further evaluation.

Get Emergency Medical Help Instructions In the event of an overdose, it is crucial to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 without delay. Prompt action is essential to mitigate potential health risks associated with overdose.

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 patients who are currently taking or have recently discontinued a prescription monoamine oxidase inhibitor (MAOI). The use of this medication is contraindicated in such cases, as it may lead to significant interactions.

Common adverse reactions include the persistence of cough. Patients are advised to stop use and consult a healthcare professional if their cough lasts more than 7 days, recurs, or is accompanied by additional symptoms such as fever, rash, or a persistent headache, as these may indicate a serious underlying condition.

Before initiating treatment, patients should seek medical advice if they have a cough that is associated with excessive phlegm (mucus) or if they have a chronic cough due to conditions such as smoking, asthma, or emphysema. These considerations are important to ensure the safe and effective use of the medication.

Drug Interactions

The concomitant use of this product with prescription monoamine oxidase inhibitors (MAOIs) is contraindicated. MAOIs are typically prescribed for the treatment of depression, certain psychiatric conditions, or Parkinson’s disease. Patients should not take this product while on MAOIs or for a minimum of two weeks following the discontinuation of an MAOI.

It is essential for patients to consult with a healthcare professional, such as a doctor or pharmacist, to verify whether their current prescription includes an MAOI before initiating treatment with this product.

Packaging & NDC

Below are the non-prescription pack sizes of Tussin Long Acting Cough (dextromethorphan hbr). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

This product is not intended for use in pediatric patients under 12 years of age. For adolescents aged 12 years and older, the recommended dosage is 10 mL every 6 to 8 hours as needed. Caution is advised when considering the use of this product in younger populations, as safety and efficacy have not been established in children under 12 years.

Geriatric Use

Elderly patients may use this product; however, it is not intended for use in children under 12 years of age. For adults, including geriatric patients aged 65 and older, the recommended dosage is 10 mL every 6 to 8 hours.

Healthcare providers should exercise caution when prescribing this medication to elderly patients, as they may have altered pharmacokinetics and pharmacodynamics. Close monitoring for efficacy and potential adverse effects is advised, particularly in this population. Adjustments to the dosage may be necessary based on individual patient response and tolerance.

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.

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 text. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the absence of guidance necessitates careful clinical judgment and monitoring based on the patient's overall health status and renal function.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to 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 prescribing information.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance. Healthcare professionals are advised to contact a Poison Control Center at 1-800-222-1222 for guidance on managing the situation effectively.

Prompt intervention is crucial in mitigating potential adverse effects associated with overdose. Symptoms may vary depending on the substance involved, and healthcare providers should be prepared to assess and manage these symptoms accordingly.

Management procedures may include supportive care and symptomatic treatment, tailored to the specific clinical presentation of the patient. Continuous monitoring and evaluation are essential to ensure patient safety and to address any complications that may arise during the course of treatment.

Nonclinical Toxicology

If pregnant or breast-feeding, it is advised to consult a health professional prior to use. No specific non-teratogenic effects have been identified. Additionally, there are no detailed findings related to nonclinical toxicology or animal pharmacology and toxicology available.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 in the event of an overdose.

Patients should be informed that this product should not be used concurrently with prescription monoamine oxidase inhibitors (MAOIs), which are medications prescribed for depression, psychiatric or emotional conditions, or Parkinson’s disease. Additionally, patients should be cautioned against using this product for at least two weeks after discontinuing an MAOI. If patients are uncertain whether their prescription medication contains an MAOI, they should be encouraged to consult with their doctor or pharmacist prior to using this product.

Healthcare providers should instruct patients to discontinue use and consult a doctor if their cough persists for more than seven days, returns, or is accompanied by symptoms such as fever, rash, or a persistent headache, as these may indicate a more serious underlying condition.

Furthermore, patients should be advised to consult a doctor before using this product if they have a cough that produces excessive phlegm (mucus) or if they have a chronic cough associated with smoking, asthma, or emphysema.

Storage and Handling

The product is supplied in a container that includes a dosing cup. It is essential to store the product at a temperature range of 20-25ºC (68-77ºF) and to avoid refrigeration.

To ensure safety and integrity, the product features a tamper-evident design. Users should not use the product if the carton is opened or if the printed safety seal around the bottle or under the cap is broken or missing.

Additional Clinical Information

The medication is administered orally, with a recommended dosage of 10 mL every 6 to 8 hours for adults and children aged 12 years and older. It is contraindicated for use in children under 12 years. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. In the event of an overdose, patients should seek medical assistance or contact a Poison Control Center immediately at 1-800-222-1222. No additional information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

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

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