Premier Value

Description

The product is available in a dosage form of 30 drops, with the National Drug Code (NDC) 61658-883-30.

Uses and Indications

This drug is indicated for the temporary relief of cough associated with the common cold. Additionally, it provides temporary relief from occasional minor irritation or sore throat.

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

Dosage and Administration

For adults and children aged 5 years and older, the recommended dosage is to dissolve 1 drop slowly in the mouth. This may be repeated every 2 hours as needed.

For children under 5 years of age, it is advised to consult a physician for appropriate dosing recommendations.

Contraindications

There are no specific contraindications identified for this product. However, healthcare professionals should advise patients to discontinue use and consult a physician under the following circumstances:

• If cough persists for more than one week, tends to recur, or is accompanied by fever, rash, or persistent headache, as these may indicate a serious condition.

• If sore mouth symptoms do not improve within 7 days.

• If irritation, pain, or redness persists or worsens.

Warnings and Precautions

If a patient experiences a severe sore throat that persists for more than two days, or if it is accompanied by symptoms such as headache, rash, swelling, nausea, or vomiting, it is imperative to consult a healthcare professional promptly, as these may indicate a serious underlying condition.

Patients should discontinue use and seek medical advice if any of the following occur: a cough that persists for more than one week, a cough that tends to recur, or a cough accompanied by fever, rash, or a persistent headache, as these symptoms could signify a serious health issue. Additionally, if a sore mouth does not show improvement within seven days, or if there is ongoing irritation, pain, or redness that persists or worsens, it is essential to contact a healthcare provider for further evaluation and management.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this product. Serious adverse reactions include severe sore throat, which, if it persists for more than 2 days or is accompanied by symptoms such as headache, rash, swelling, nausea, or vomiting, warrants prompt consultation with a healthcare professional. These symptoms may indicate a serious underlying condition.

Common adverse reactions necessitate immediate medical attention if they occur. Patients should stop use and consult a doctor if a cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache, as these may also signify a serious condition. Additionally, if a sore mouth does not improve within 7 days, or if irritation, pain, or redness persists or worsens, patients are advised to seek medical advice.

Before using this product, patients should consult a healthcare provider if they have a persistent or chronic cough, such as that associated with smoking, asthma, or emphysema, or if their cough is accompanied by excessive phlegm (mucus). These considerations are important to ensure safe and effective use of the product.

Drug Interactions

No specific drug interactions have been identified in the available data. Additionally, there are no reported interactions with laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on the current information.

Packaging & NDC

Below are the non-prescription pack sizes of Premier Value (cough drops cherry). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 5 years of age should consult a healthcare professional before use. For children aged 5 years and older, the recommended dosage is to dissolve 1 drop slowly in the mouth, with the option to repeat every 2 hours as needed.

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

There is no information available regarding the use of this drug during pregnancy, including safety concerns, dosage modifications, or any special precautions that should be taken. Healthcare professionals are advised to consider the lack of data when prescribing this medication to pregnant patients and to weigh the potential risks and benefits. Women of childbearing potential should be counseled accordingly.

Lactation

Nursing mothers should consult a doctor before using this product. There is a potential for excretion in breast milk, and the effects on the nursing infant are not well studied; therefore, caution is advised.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring.

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 absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise, as the clinical presentation can vary depending on the substance involved. Common symptoms of overdose may include, but are not limited to, respiratory depression, altered mental status, cardiovascular instability, and gastrointestinal disturbances.

In the event of an overdose, immediate medical intervention is recommended. Healthcare providers should initiate supportive care, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs. The use of activated charcoal may be considered if the patient presents within a suitable timeframe and if the ingestion was recent.

Furthermore, it is crucial to consult local poison control centers or toxicology experts for guidance on specific management protocols tailored to the substance involved. Continuous assessment and supportive measures should be prioritized to ensure patient safety and mitigate potential complications associated with overdose.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

Adverse events have been reported voluntarily and through surveillance programs. Healthcare professionals and patients are encouraged to report any adverse events to the designated contact number, 800-245-2898, available Monday through Friday from 9 AM to 5 PM EST.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. Patients should be instructed to stop using the medication and consult a doctor if their cough persists for more than one week, tends to recur, or is accompanied by fever, rash, or a persistent headache, as these symptoms may indicate a serious condition. Additionally, if a sore mouth does not improve within 7 days, or if irritation, pain, or redness persists or worsens, patients should seek medical advice.

It is also important for healthcare providers to encourage patients to ask a doctor before using the medication if they have a persistent or chronic cough, such as that which occurs with smoking, asthma, or emphysema, or if their cough is accompanied by excessive phlegm (mucus). This ensures that patients receive appropriate guidance based on their individual health circumstances.

Storage and Handling

The product is available in various package configurations, with specific NDC numbers assigned for identification. Storage and handling instructions are not explicitly provided; therefore, standard practices for pharmaceutical products should be followed. It is advisable to store the product in a controlled environment, ensuring that it is kept at appropriate temperature ranges to maintain its integrity. Containers should be secure and suitable for the product type to prevent contamination or degradation. Special handling needs are not specified, but general precautions should be taken to ensure the product's safety and efficacy during storage and transportation.

Additional Clinical Information

The medication is administered orally. For adults and children aged 5 years and older, the recommended dosage is to dissolve 1 drop slowly in the mouth, with the option to repeat every 2 hours as needed. For children under 5 years of age, it is advised to consult a doctor for appropriate guidance.

No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences.

Drug Information (PDF)

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

View product document (PDF)