Halls

Description

Blueberry Art is a product characterized by its unique formulation and aesthetic appeal. It is designed to provide a visually engaging experience, incorporating the essence of blueberries in its composition. The product's specific molecular weight and chemical formula are proprietary, contributing to its distinct properties. The dosage form is tailored to meet professional standards, ensuring optimal performance and usability. The appearance of Blueberry Art is defined by its vibrant color and texture, reflecting the natural qualities of blueberries.

Uses and Indications

This drug is indicated for the temporary relief of cough due to a 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 should dissolve 2 drops of the medication, one at a time, 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 before administration.

Contraindications

There are no specific contraindications identified for this product. However, it is advised to discontinue use and consult a healthcare professional if the following conditions occur:

• Cough persists for more than one week, recurs, or is accompanied by fever, rash, or persistent headache, as these may indicate a serious underlying condition.

• Sore mouth does not improve within 7 days, or 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 fever, headache, rash, swelling, nausea, or vomiting, it is imperative to consult a healthcare professional promptly. These symptoms may indicate a serious underlying condition that requires immediate attention.

Patients should discontinue use and seek medical advice if they experience a cough that persists for more than one week, recurs, or is accompanied by fever, rash, or a persistent headache. These signs may suggest a serious health issue that necessitates further evaluation. Additionally, if a sore mouth does not show improvement within seven days, or if irritation, pain, or redness persists or worsens, it is essential to contact a healthcare provider for further assessment and management.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this medication. Serious adverse reactions warrant immediate medical attention. A notable warning includes the potential for severe sore throat, which, if it persists for more than 2 days or is accompanied by symptoms such as fever, headache, rash, swelling, nausea, or vomiting, should prompt patients to consult a healthcare professional promptly, as these may indicate a serious condition.

Additionally, patients are advised to discontinue use and seek medical advice if a cough persists for more than 1 week, recurs, or is accompanied by fever, rash, or a persistent headache, as these symptoms could signify a serious underlying issue. Similarly, if a sore mouth does not show improvement within 7 days, or if irritation, pain, or redness persists or worsens, patients should contact their healthcare provider.

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

Drug Interactions

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

Packaging & NDC

Below are the non-prescription pack sizes of Halls (menthol). 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 2 drops (one at a time) slowly in the mouth, with the option to repeat every 2 hours as needed.

Geriatric Use

There is no specific information 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 they may have altered pharmacokinetics and pharmacodynamics. Close monitoring is recommended to ensure safety and efficacy in this population.

Pregnancy

There is no specific information available regarding the use of this medication during pregnancy, including safety concerns, dosage modifications, or special precautions. Healthcare professionals should consider the lack of data when prescribing this medication to pregnant patients. It is advisable to weigh the potential benefits against any unknown risks to fetal outcomes. Women of childbearing potential should be counseled on the importance of effective contraception during treatment.

Lactation

There are no specific warnings or recommendations regarding the use of HALLS BLUEBERRY menthol lozenge in lactating mothers. Additionally, there is no information available about the potential for excretion of the product in breast milk or any associated risks to breastfed infants.

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 and consider individual patient factors when prescribing to patients with renal impairment, as the absence of detailed guidance necessitates careful clinical judgment.

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 when administering the medication. It is essential to monitor patients closely for any signs of adverse effects or unexpected reactions.

In the event of suspected overdosage, standard medical protocols should be followed. This includes assessing the patient's clinical status and providing supportive care as necessary. Healthcare providers should consider contacting a poison control center for guidance on management strategies tailored to the specific circumstances of the overdosage.

As there are no documented symptoms or management procedures associated with overdosage for this medication, it is imperative that healthcare professionals remain vigilant and report any unusual findings to the appropriate regulatory authorities.

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 question.

Postmarketing Experience

No postmarketing experience details are available for SPL code 90375-7.

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, patients should be informed to seek medical advice if their sore mouth does not improve within 7 days, or if they experience worsening irritation, pain, or redness. It is also important for healthcare providers to recommend that patients consult a doctor before using the medication 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).

Storage and Handling

The product is supplied in a configuration that ensures optimal handling and storage. It should be stored at room temperature to maintain its efficacy. Additionally, it is imperative to keep the product out of reach of children to ensure safety.

Additional Clinical Information

The medication is administered orally. For adults and children aged 5 years and older, the recommended dosage is to dissolve 2 drops (one at a time) 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.

There is no additional information available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

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

View product document (PDF)