Vapor Shower

Description

The product is identified by the SPL code 34089-3. No additional specific description details are provided in the available data.

Uses and Indications

This drug is indicated for the temporary relief of cough due to the common cold.

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

Dosage and Administration

Healthcare professionals should instruct patients to cut open the pouch and place the tablet directly on the shower floor. For optimal release of soothing vapors, the tablet should be positioned in the direct stream of water during the shower. It is important to note that this product is not intended for use in a bath setting. This product is designated for adult use only. Unused tablets should be stored in a dry place to maintain their efficacy.

Contraindications

Use of this product is contraindicated in the following situations:

• The product should be kept out of reach of children to prevent accidental ingestion.

• In the event of accidental swallowing, immediate medical assistance should be sought.

• The product must be kept away from the eyes to avoid irritation or injury.

Warnings and Precautions

The product is considered harmful if swallowed or placed in the mouth. It is imperative that this product is kept out of reach of children to prevent accidental ingestion. In the event of accidental swallowing, immediate medical assistance should be sought to ensure appropriate care is provided.

Additionally, care should be taken to avoid contact with the eyes, as exposure may lead to irritation or other adverse effects. It is essential for healthcare professionals to educate patients and caregivers about these precautions to promote safe handling and use of the product.

Side Effects

Patients should be aware that the product is harmful if swallowed or put in the mouth. This warning highlights the potential for serious adverse reactions associated with improper use.

In clinical trials and postmarketing experiences, no additional adverse reactions have been reported beyond the noted warning. It is essential for patients to follow usage instructions carefully to avoid any harmful effects.

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 Vapor Shower (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

This medication is indicated for adult use only and is not approved for pediatric patients. It is essential to keep this product out of reach of children to prevent accidental ingestion. The medication is harmful if swallowed or placed in the mouth; in such cases, immediate medical assistance should be sought.

Geriatric Use

Elderly patients are defined as individuals aged 65 years and older. The prescribing information does not provide specific details regarding the use of this medication in geriatric patients, including any necessary dosage adjustments, safety concerns, or special precautions that should be considered.

Healthcare providers should exercise caution when prescribing this medication to elderly patients, given the absence of targeted clinical findings or recommendations for this population. It is advisable to monitor these patients closely for any potential adverse effects or changes in therapeutic response.

Pregnancy

Pregnant patients and those who are lactating should consult their physician prior to using this medication. It is essential for healthcare providers to evaluate the potential risks and benefits associated with the use of this drug during pregnancy and lactation, as well as to consider alternative treatment options that may be safer for both the mother and the fetus.

Lactation

Lactating mothers are advised to consult a physician if they are pregnant or breastfeeding. There is no specific data available regarding the excretion of the drug in human breast milk or its effects on breastfed infants. Therefore, healthcare professionals should exercise caution and consider the potential risks and benefits when prescribing this medication to lactating mothers.

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 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 and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should implement supportive care measures, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

If available, specific antidotes or treatments should be administered as indicated based on the clinical scenario and the substance involved. Consultation with a poison control center or a medical toxicologist may also be beneficial in managing the situation effectively.

Documentation of the incident, including the substance involved, the amount ingested, and the time of ingestion, is crucial for guiding treatment decisions and ensuring patient safety.

Nonclinical Toxicology

Consultation with a physician is advised for individuals who are pregnant or lactating due to potential teratogenic effects. No non-teratogenic effects have been specified in the available data. Additionally, there are no details provided regarding nonclinical toxicology or animal pharmacology and toxicology.

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. It is important to inform patients that if the medication is accidentally swallowed, they should seek medical help immediately. Additionally, patients should be cautioned to keep the medication away from their eyes to avoid irritation or injury.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the unused product in a dry place to maintain its integrity and effectiveness. Proper storage conditions are crucial to ensure the product remains in optimal condition until use.

Additional Clinical Information

The product is administered topically. Clinicians should counsel patients on the potential risks associated with the product, emphasizing that it is harmful if swallowed or placed in the mouth. Patients should be advised to keep the product out of reach of children and to seek medical assistance if accidental ingestion occurs. Additionally, it is important to keep the product away from the eyes and to consult a physician if pregnant or lactating.

Drug Information (PDF)

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

View product document (PDF)