Premier Value

Description

The product is identified by the National Drug Code (NDC) 68016-884-30. It is formulated as a solution containing 30 drops per unit. The labeling is consistent with the specifications outlined in the PV label.

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

Adults and children aged 5 years and older are instructed to dissolve 1 drop slowly in the mouth. This process may be repeated every 2 hours as needed. For children under 5 years of age, it is recommended to consult a physician for appropriate dosing guidance.

Contraindications

Use is contraindicated in patients who experience a cough that persists for more than one week, tends to recur, or is accompanied by fever, rash, or persistent headache, as these may indicate a serious underlying condition. Additionally, discontinue use if a sore mouth does not improve within 7 days. Patients should also stop use 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 or followed 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.

In addition, 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. Furthermore, 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 medication. 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 necessitating the cessation of use include a cough that persists for more than 1 week, recurs, or is accompanied by fever, rash, or persistent headache, as these could 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 should stop use and seek medical advice.

Before using this medication, patients are advised to consult a doctor 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).

Drug Interactions

There are no specific drug interactions or laboratory test interactions identified in the available data. Therefore, no dosage adjustments or monitoring recommendations are necessary at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Premier Value (cough drops honey lemon). 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

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any potential adverse effects or changes in efficacy, given the lack of targeted data for this population.

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, and alternative treatment options should be explored if necessary.

Lactation

There are no specific warnings or recommendations regarding nursing mothers or lactation in the provided text. Therefore, healthcare professionals should consider the absence of data when advising lactating mothers about the use of this medication. It is advisable to monitor breastfed infants for any potential effects, although no specific concerns have been identified in the available information.

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 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

There is currently no specific information available regarding overdosage in the provided sections of the Summary of Product Characteristics (SPL).

Healthcare professionals are advised to monitor patients closely for any signs or symptoms that may arise in the event of an overdose. In the absence of detailed overdosage data, it is prudent to implement general supportive measures and symptomatic treatment as necessary.

In cases of suspected overdosage, it is recommended that healthcare providers contact a poison control center or seek expert consultation to determine the most appropriate management strategies. Continuous assessment of the patient's clinical status is essential to ensure timely intervention and to mitigate potential adverse effects.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the assessment of potential risks associated with the use of the compound in these contexts.

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 4 PM EST. This reporting contributes to the ongoing monitoring of the product's safety profile.

Patient Counseling

Healthcare providers should advise patients to keep this 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 remind patients to ask a doctor before using this 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).

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 requirements, if any, should be determined based on the product's characteristics and standard industry guidelines.

Additional Clinical Information

No further data are available.

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)