Premier Value

Description

The product is identified by the National Drug Code (NDC) 61658-886-25. Further details regarding its chemical composition, dosage form, and inactive ingredients are not provided in the extracted facts.

Uses and Indications

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

There are no teratogenic effects associated with this drug, and no nonteratogenic effects have been reported.

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 symptom relief.

For children under 5 years of age, it is recommended to consult a physician before administration.

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 and consult a healthcare professional if a sore mouth does not improve within 7 days. Patients should also stop use and seek medical advice if irritation, pain, or redness persists or worsens.

Warnings and Precautions

Patients should be advised to seek medical attention if they experience a severe sore throat that persists for more than two days, particularly if it is accompanied or followed by symptoms such as headache, rash, swelling, nausea, or vomiting, as these may indicate a serious underlying condition.

In addition, patients are instructed to discontinue use and consult a healthcare professional 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 irritation, pain, or redness persists or worsens, medical advice should be sought.

Healthcare professionals should exercise caution and advise patients to consult a doctor prior to use 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).

Emergency medical assistance should be sought if any severe or concerning symptoms arise, although specific instructions for such situations were not provided in the available information.

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 provider. 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 be signs of 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 medication, 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).

Drug Interactions

No specific drug interactions have been identified for this medication. Additionally, there are no reported interactions with laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug or laboratory test interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Premier Value (cough drops black cherry sugar free). 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 adverse effects or changes in therapeutic response, 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.

Lactation

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

Renal Impairment

There is no specific information regarding renal impairment, dosage adjustments, special monitoring, or safety considerations for patients with reduced kidney function provided in the insert text. Healthcare professionals should exercise caution when prescribing to patients with renal impairment, as the absence of detailed guidance 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, it is essential for healthcare professionals to remain vigilant and exercise caution when administering the medication.

Should an overdosage occur, it is recommended that healthcare providers assess the patient for any potential symptoms that may arise, although specific symptoms have not been detailed in the available data.

Management of an overdosage situation should involve standard supportive care measures. This may include monitoring vital signs, providing symptomatic treatment, and ensuring the patient is stable.

Healthcare professionals are advised to consult local poison control centers or relevant medical authorities for guidance on managing suspected overdosage cases, as they can provide tailored recommendations based on the clinical scenario.

In summary, while no specific overdosage information is provided, healthcare professionals should prioritize patient safety and follow established protocols for managing potential overdosage situations.

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 compound in these areas.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

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 temperatures to maintain its integrity. Containers should be kept sealed and protected from light and moisture to prevent degradation. Special handling requirements are not specified, but general precautions should be taken to ensure the product's quality and safety 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 experience.

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)