Saint

Description

The product is identified by SPL Code 34089-3 and is presented as a white to off-white, round, biconvex tablet. Each tablet is debossed with "72784" on one side and "101" on the opposite side. It contains 500 mg of the active ingredient. The formulation includes the following inactive ingredients: microcrystalline cellulose, croscarmellose sodium, magnesium stearate, hydroxypropyl methylcellulose, titanium dioxide, polyethylene glycol, iron oxide red, and iron oxide yellow.

Uses and Indications

This drug is indicated for the relief of cough and the elimination of phlegm, as well as for its anti-inflammatory properties. It is effective in alleviating symptoms associated with headache, sore throat, red eyes, and discomfort in the throat and lungs.

This drug is suitable for cough caused by various conditions, including the common cold, tracheitis, bronchitis, pulmonary fibrosis, and pulmonary sarcoidosis.

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

Dosage and Administration

For adults and children aged 2 years and older, the recommended dosage is 1 tablespoon of the solution for each quart of water or 1½ teaspoonful of the solution for each pint of water. The solution should be added directly to cold water only in a hot steam vaporizer, following the manufacturer's directions for the use of the vaporizer. Patients should breathe in the medicated vapors.

This treatment may be administered up to three times daily or as directed by a healthcare professional. For children under 2 years of age, it is advised to consult a doctor before use.

Contraindications

There are no contraindications explicitly stated for this product. It is important to evaluate individual patient circumstances and clinical judgment when considering its use.

Warnings and Precautions

This product is intended for external use only and is specifically formulated for nebulization inhalation. It is imperative that this product not be taken orally, as doing so may lead to adverse effects.

Healthcare professionals should ensure that this product is stored safely, out of the reach of children, to prevent accidental ingestion. In the event of accidental swallowing, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended to mitigate potential risks.

Monitoring for any adverse reactions following use is advised, particularly in populations at higher risk.

Side Effects

Patients using this product should be aware of several important warnings and precautions. The product is intended for external use only and is specifically formulated for nebulization inhalation; it should not be taken orally. It is crucial to keep this product out of the reach of children. In the event of accidental ingestion, patients are advised to seek medical assistance or contact a Poison Control Center immediately.

Consultation with a healthcare provider is recommended for patients with chronic obstructive pulmonary disease (COPD), persistent chronic cough, asthma, emphysema, or severe pulmonary heart disease. Additionally, individuals with a history of long-term smoking, coughing, or cancer should also seek medical advice prior to use. Special consideration should be given to pregnant and lactating women, as well as children under the age of 12, who may require further evaluation before using this product.

Drug Interactions

The use of this medication may lead to significant interactions in specific patient populations. It is advised that healthcare professionals consult with a physician when prescribing this medication to patients with the following conditions:

• Chronic Obstructive Pulmonary Disease (COPD): Caution is warranted in patients with COPD or a persistent chronic cough.

• Asthma and Emphysema: Consultation with a physician is recommended for patients with asthma or emphysema.

• Long-term Smoking and Cancer: Patients with a history of long-term smoking, persistent coughing, or those diagnosed with cancer should be closely monitored.

• Severe Pulmonary Heart Disease: Patients with severe pulmonary heart disease require careful evaluation before initiating treatment.

• Pregnancy and Lactation: Special consideration should be given to pregnant and lactating women, necessitating consultation with a healthcare provider.

• Pediatric Patients: The use of this medication in children under the age of 12 should be approached with caution, and a physician should be consulted.

No specific drug or laboratory test interactions have been identified in the available data.

Packaging & NDC

Below are the non-prescription pack sizes of Saint (cough spray). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 2 years of age should consult a doctor before use. For children aged 2 years and older, the recommended dosage is 1 tablespoon of solution per quart of water or 1½ teaspoonfuls of solution per pint of water. This dosage may be administered up to three times daily or as directed by a healthcare professional.

Caution is advised when using this product in pregnant women, lactating women, and children under the age of 12. It is essential for healthcare providers to evaluate the appropriateness of treatment in these populations.

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 elderly patients closely for any potential adverse effects or changes in therapeutic response, given the lack of targeted data for this population. Consideration of individual patient factors, including comorbidities and concurrent medications, is essential in managing treatment effectively.

Pregnancy

Pregnant women should consult a healthcare professional prior to using this medication. The safety of this drug during pregnancy has not been established, and potential risks to fetal outcomes are not fully understood. It is important for women of childbearing potential to discuss their pregnancy status and any plans for pregnancy with their healthcare provider before initiating treatment. Additionally, lactating women and children under the age of 12 are also advised to seek medical guidance before use.

Lactation

Lactating mothers are advised to consult a healthcare professional prior to using this product. There is no specific data available regarding the excretion of this product in breast milk or its effects on breastfed infants. Caution is recommended when considering the use of this product during lactation, particularly for those with infants under the age of 12.

Renal Impairment

There is no information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution and consider the lack of specific guidance when prescribing to patients with reduced kidney function.

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 event of an overdosage, immediate medical intervention is crucial. If the substance is ingested, it is imperative to seek medical assistance or contact a Poison Control Center without delay.

Healthcare professionals should be aware that prompt action can significantly influence the outcome of an overdosage situation. Symptoms of overdosage may vary depending on the specific substance involved; therefore, a thorough assessment of the patient's condition is essential.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous monitoring and evaluation are recommended to address any complications that may arise during the management of an overdosage.

In summary, swift action and appropriate medical guidance are vital in the event of an overdosage to ensure patient safety and effective treatment.

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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are available in the extracted data.

Patient Counseling

Healthcare providers should advise patients to keep this product out of the reach of children to prevent accidental ingestion. It is important to emphasize the necessity of using the product strictly as instructed to ensure safety and efficacy.

Patients with a history of allergies should be encouraged to observe their reactions closely when using the product. Healthcare providers should also recommend that patients consult a doctor prior to use if they have any of the following conditions: chronic obstructive pulmonary disease (COPD) or a persistent chronic cough, asthma or emphysema, a history of long-term smoking and coughing, or cancer. Additionally, patients with severe pulmonary heart disease should seek medical advice before using the product.

Special consideration should be given to pregnant women, lactating women, and children under the age of 12, as these populations may require further evaluation and guidance from a healthcare professional before use.

Storage and Handling

The product is supplied in a configuration that ensures optimal preservation of its integrity. It must be stored strictly away from light to prevent degradation. Additionally, it is essential to maintain a low temperature during storage to ensure the product remains effective and safe for use. Proper handling and storage conditions are critical to maintaining the quality of the product.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)