Halls

Description

Halls SF Mini Watermelon is presented in a pouch format, designed for convenient access and portability. The product features a front and back design that showcases its branding and product information. The formulation is specifically designed to provide a refreshing watermelon flavor while being sugar-free. The pouch contains a specified quantity of the product, which is intended for use as a throat lozenge. The appearance of the pouch is consistent with standard packaging for similar products in the market.

Uses and Indications

This drug is indicated for the temporary relief of cough due to a cold and for the alleviation of 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 2 drops of the medication, one at a time, 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 prior to 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 promptly if they experience a severe sore throat that persists for more than two days, especially if it is accompanied by fever, headache, rash, swelling, nausea, or vomiting, as these symptoms may indicate a serious underlying condition.

In addition, patients are instructed to discontinue use and contact their healthcare provider if a cough persists for more than one week, recurs, or is associated with fever, rash, or a persistent headache, as these may also signal a serious health issue. A sore mouth that does not show improvement within seven days warrants further evaluation by a healthcare professional. Furthermore, any irritation, pain, or redness that persists or worsens should be reported to a doctor.

In the event of an overdose, immediate medical assistance should be sought, or the patient should contact a Poison Control Center without delay to ensure appropriate 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, particularly if it persists for more than 2 days or is accompanied by symptoms such as fever, headache, rash, swelling, nausea, or vomiting. In such cases, patients are advised to consult a doctor promptly, as these symptoms may indicate a serious condition.

Common adverse reactions warranting attention include a persistent cough that lasts more than 1 week, recurs, or is accompanied by fever, rash, or a persistent headache. These symptoms should prompt patients to seek medical advice, as they may signify a serious underlying issue. 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 consult a healthcare professional.

Patients with a history of persistent or chronic cough, such as that associated with smoking, asthma, or emphysema, should seek medical advice before using this medication. Furthermore, those experiencing a cough accompanied by excessive phlegm (mucus) are also encouraged to consult a doctor prior to use.

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 individual responses may vary. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

There is no specific information 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 this medication in nursing mothers. Additionally, there are no specific warnings or recommendations related to lactation. Healthcare professionals should consider the absence of data when advising lactating mothers about the use of this medication.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. 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 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 patients closely for any signs or symptoms that may arise following an overdose. Common symptoms may include, but are not limited to, alterations in consciousness, cardiovascular instability, and gastrointestinal disturbances.

In the event of an overdose, immediate medical attention should be sought. Supportive care is the cornerstone of management, which may include monitoring vital signs, providing symptomatic treatment, and ensuring the patient's safety.

Healthcare professionals should also consider contacting a poison control center for guidance on specific interventions and management strategies tailored to the substance involved in the overdose.

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 for SPL code 90375-7.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center in the event of an overdose. It is crucial for patients to understand the importance of prompt action in such situations to ensure their safety and well-being.

Storage and Handling

The product is supplied in a configuration that ensures optimal usability. It should be stored at room temperature, away from excessive heat and moisture to maintain its integrity. It is essential to keep the container tightly closed when not in use to prevent contamination and degradation of the product.

Additionally, the product must be kept out of reach of children to ensure safety. It is advised to discard the product after opening if it is not used within a specified period, although the exact duration is not provided.

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 dosing 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)