Premier Value Tussin Cough

Description

Tussin Cough Long-Acting is a cough suppressant formulated with Dextromethorphan HBr, designed to control coughs effectively. This product provides up to 8 hours of relief and is non-drowsy, making it suitable for use during the day. It is intended for individuals aged 12 years and older. The product is available in a liquid dosage form, with a volume of 4 fluid ounces (118 mL). The packaging includes a tamper-evident feature, and it should not be used if the printed safety seal on the bottle is broken or missing.

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. Additionally, it aids in loosening phlegm (mucus) and thinning bronchial secretions, facilitating drainage of the bronchial tubes.

Limitations of Use: This medication is intended for symptomatic relief and does not address the underlying cause of cough or respiratory conditions.

Dosage and Administration

The product should be shaken well before each use. For adults and children aged 12 years and older, the recommended dosage is 10 mL administered every 6 to 8 hours as needed. It is important to not exceed 4 doses within a 24-hour period. The dosing should be measured exclusively with the dosing cup provided, which should be kept with the product at all times. 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 they are uncertain whether their prescription medication contains an MAOI.

Warnings and Precautions

Do not use this product concurrently with prescription monoamine oxidase inhibitors (MAOIs), which are medications prescribed for depression, psychiatric or emotional conditions, or Parkinson’s disease. Additionally, it is contraindicated for use within 2 weeks following the discontinuation of an MAOI. If there is uncertainty regarding the presence of an MAOI in a prescription medication, it is imperative to consult a healthcare professional, such as a doctor or pharmacist, prior to use.

Healthcare professionals should advise patients to seek medical guidance before using this product if they have a cough associated with excessive phlegm (mucus) or if they experience a chronic cough, which may be indicative of underlying conditions such as smoking, asthma, or emphysema.

Patients are instructed to discontinue use and consult a healthcare provider if the cough persists for more than 7 days, recurs, or is accompanied by additional symptoms such as fever, rash, or a persistent headache. These symptoms may indicate a more serious underlying condition that requires medical evaluation.

In the event of an overdose, it is critical to seek immediate medical assistance or contact a Poison Control Center at (1-800-222-1222) without delay.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this medication. Serious adverse reactions may occur, and patients are advised to discontinue use and consult a healthcare professional if they experience a cough that lasts more than 7 days, recurs, or is accompanied by fever, rash, or persistent headache, as these symptoms could indicate a serious underlying condition.

It is important to note that this medication should not be used concurrently with prescription monoamine oxidase inhibitors (MAOIs) or within 2 weeks of discontinuing an MAOI. Patients should also seek medical advice prior to use if they have a cough that is productive of excessive phlegm (mucus) or if they have a chronic cough associated with conditions such as smoking, asthma, or emphysema.

These precautions are essential to ensure patient safety and to mitigate the risk of serious adverse effects.

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, psychiatric or emotional conditions, and 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 medication contains an MAOI before initiating treatment with this product.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 12 years of age should not use this product. For patients aged 12 years and older, the recommended dosage is 10 mL every 6 to 8 hours. It is important to note that this product is specifically intended for adults and children 12 years and older, and its use in younger children is contraindicated.

Geriatric Use

Elderly patients may require careful consideration when using this adult product, which is not intended for use in children under 12 years of age. While specific dosage adjustments for geriatric patients are not provided, healthcare providers should exercise caution and closely monitor this population for any adverse effects or changes in efficacy. It is essential to evaluate the overall health status and comorbidities of elderly patients, as these factors may influence the safety and effectiveness of the treatment. Regular assessment and appropriate dose modifications may be necessary to ensure optimal therapeutic outcomes in this demographic.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is essential to evaluate the potential risks and benefits associated with its 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 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. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this drug. Consequently, there are no 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 or contact a Poison Control Center without delay. Healthcare professionals are advised to call the Poison Control Center at (1-800-222-1222) for guidance on managing the situation.

Prompt intervention is crucial, as the specific symptoms and severity of an overdose can vary based on the substance involved. Therefore, a thorough assessment and appropriate management strategies should be initiated as soon as possible to mitigate potential risks and complications associated with the overdose.

Nonclinical Toxicology

If pregnant or breastfeeding, 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 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 for accurate measurement. It is essential to store the product at a temperature range of 20-25°C (68-77°F) and to avoid refrigeration. Prior to use, the product must be shaken well to ensure proper consistency. Users should measure the dosage exclusively with the provided dosing cup and keep it with the product at all times. Additionally, the product features a tamper-evident safety seal; it should not be used if the seal on the bottle is broken or missing.

Additional Clinical Information

Patients should be informed that the medication is administered orally and that they should not exceed four doses within a 24-hour period. Clinicians are advised to counsel patients regarding the importance of consulting a health professional if they are pregnant or breastfeeding before using the medication.

Additionally, parents are encouraged to educate themselves about the potential for medicine abuse among teenagers by visiting www.StopMedicineAbuse.org. No further information is available regarding laboratory tests or postmarketing experiences.

Drug Information (PDF)

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

View product document (PDF)