Vapor Shower

Description

SPL code 34089-3 corresponds to a product represented by an image file named "CM Shower tablet.jpg." The media type of the image is JPEG, which provides a visual reference for the product. Further details regarding the chemical composition, dosage form, or inactive ingredients are not provided in the extracted facts.

Uses and Indications

This drug is indicated for the temporary relief of cough associated with the common cold.

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

Dosage and Administration

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

Contraindications

There are no specific contraindications listed for this product. However, it is essential to adhere to the following precautions:

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

• In the event of accidental swallowing, seek medical assistance immediately.

• Avoid contact with eyes to prevent 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, it is crucial to keep the product away from the eyes to avoid potential irritation or injury. Healthcare professionals should advise patients and caregivers on 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 specific adverse reactions have been reported. However, the seriousness of the warning necessitates careful handling and adherence to usage guidelines to prevent any harmful outcomes. It is essential for patients to follow instructions closely to mitigate risks associated with accidental ingestion or misuse.

Drug Interactions

There are no specific drug interactions or laboratory test interactions identified in the available data. Therefore, no dosage adjustments or monitoring recommendations are necessary at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Vapor Shower (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients should not use this medication, as it is indicated for adult use only. 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 the event of accidental ingestion, immediate medical assistance should be sought.

Geriatric Use

Elderly patients, defined as those aged 65 years and older, are not specifically addressed in the prescribing information regarding dosage adjustments, safety concerns, or special precautions. As the product is indicated for adult use only, healthcare providers should exercise caution when considering its use in this population.

Due to the absence of specific data on geriatric patients, it is advisable for healthcare providers to closely monitor elderly patients for any potential adverse effects or complications that may arise during treatment. Individual patient factors, including comorbidities and concurrent medications, should be taken into account when prescribing this medication to older adults.

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.

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 patients.

Renal Impairment

Renal impairment may necessitate dosage adjustments for patients with reduced kidney function. It is important to monitor renal function tests in these patients to ensure safety and efficacy. Additionally, a reduced dose should be considered for patients with decreased creatinine clearance to mitigate the risk of adverse effects.

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 initiate supportive care, which may include maintaining airway patency, ensuring adequate ventilation, and monitoring vital signs.

If available, the use of specific antidotes or treatments should be considered based on the clinical scenario and the substance involved. Consultation with a poison control center or a medical toxicologist may provide additional guidance on the management of overdose cases.

Documentation of the incident, including the amount and timing of the substance taken, is crucial for effective treatment and follow-up care.

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 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 hazards 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 the patient is 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)