Kroger No Drip Nasal Mist Severe Congestion

Description

NDC 41226-718-30 identifies a nasal decongestant formulation containing oxymetazoline hydrochloride as the active ingredient, comparable to the active ingredient in Afrin® No Drip Severe Congestion Pump Mist. This product is designed as a nasal mist, specifically formulated to provide fast and powerful relief from severe congestion associated with colds and allergies. The formulation is presented in a 1 fluid ounce (30 mL) pump mist dosage form, ensuring that it does not drip from the nose or down the throat. It offers maximum strength relief, enhanced with menthol, and provides up to 12 hours of congestion relief.

Uses and Indications

This drug is indicated for the temporary relief of nasal congestion associated with the common cold, hay fever, and upper respiratory allergies. It also provides temporary relief from sinus congestion and pressure. Additionally, this drug acts to shrink swollen nasal membranes, facilitating easier breathing.

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

Dosage and Administration

Adults and children aged 6 to under 12 years, under adult supervision, may receive 2 or 3 sprays in each nostril. Dosing should not occur more frequently than every 10 to 12 hours, and the total number of doses should not exceed 2 in any 24-hour period.

For children under 6 years of age, it is advised to consult a physician before administration.

Prior to use, the product must be shaken well. To prepare the bottle for use, push down the cap while turning it counter-clockwise to remove it. Remove the clip located under the rim of the bottle. Before the initial use, the metered pump should be primed by firmly depressing the pump several times.

For administration, hold the bottle with the thumb at the base and the nozzle rim positioned between the first and second fingers. Without tilting the head, insert the nozzle into the nostril. Fully depress the rim with a firm, even stroke while sniffing deeply. After use, the nozzle should be wiped clean, and the clip should be replaced under the rim before securing the cap.

Contraindications

Use is contraindicated in patients who exceed the directed dosage or utilize the product for more than three consecutive days. Prolonged or frequent use may lead to a recurrence or worsening of nasal congestion.

Warnings and Precautions

Healthcare professionals should exercise caution when recommending this product, particularly in patients with specific underlying health conditions. Prior to use, it is imperative to consult a physician if the patient has a history of heart disease, high blood pressure, thyroid disease, diabetes, or experiences difficulty urinating due to an enlarged prostate gland.

It is essential to adhere strictly to the recommended dosage guidelines. Patients should not exceed the directed use and should limit the duration of use to no more than three days. Prolonged or frequent use may lead to a recurrence or exacerbation of nasal congestion. Patients may experience temporary discomfort, including burning, stinging, sneezing, or an increase in nasal discharge. Additionally, the use of this product by multiple individuals may pose a risk of infection transmission.

If symptoms persist despite use, patients should discontinue use and seek medical advice. In the event of accidental ingestion, immediate medical assistance should be sought, or the Poison Control Center should be contacted at 1-800-222-1222.

Side Effects

Patients using this product may experience temporary discomfort, which can include sensations of burning, stinging, sneezing, or an increase in nasal discharge. These reactions are generally mild and transient.

If symptoms persist, patients are advised to discontinue use and consult a healthcare professional for further evaluation and guidance.

Drug Interactions

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

Packaging & NDC

Below are the non-prescription pack sizes of Kroger No Drip Nasal Mist Severe Congestion (oxymetazoline hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 6 years of age should consult a healthcare professional before use. For children aged 6 to under 12 years, the recommended dosage is 2 or 3 sprays in each nostril, administered no more frequently than every 10 to 12 hours. It is important not to exceed 2 doses within a 24-hour period, and adult supervision is advised during administration.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients. The prescribing information does not provide any recommended age considerations, dosage adjustments, safety concerns, or special precautions for elderly patients. Therefore, healthcare providers should exercise clinical judgment when prescribing this medication to geriatric patients, taking into account individual patient factors and overall health status. Regular monitoring may be warranted to ensure safety and efficacy in this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure safe use during pregnancy and lactation.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data regarding the excretion of this medication in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

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 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 assistance is crucial. If the substance is ingested, healthcare professionals should advise patients or caregivers to seek medical help without delay. It is recommended to contact a Poison Control Center at 1-800-222-1222 for expert guidance on managing the situation.

Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. Healthcare providers should be prepared to assess the patient's condition and implement appropriate management strategies based on the severity of symptoms and the specific substance involved.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to use. Temporary discomfort may occur, including symptoms such as burning, stinging, sneezing, or an increase in nasal discharge. No relevant information regarding carcinogenicity, mutagenicity, or impairment of fertility has been provided in the insert. Additionally, there is no relevant information available concerning animal pharmacology and toxicology.

Postmarketing Experience

No postmarketing experience details are provided in the insert.

Patient Counseling

Advise patients to keep this product out of reach of children. Instruct them that if the product is swallowed, they should seek medical help or contact a Poison Control Center immediately at 1-800-222-1222.

Inform patients to stop using the product and consult a doctor if symptoms persist. When using this product, it is important to emphasize that they should not exceed the directed dosage and should not use it for more than three days. Patients should be made aware that frequent or prolonged use may lead to a recurrence or worsening of nasal congestion.

Patients may experience temporary discomfort, including burning, stinging, sneezing, or an increase in nasal discharge. Additionally, caution them that the use of this container by more than one person may increase the risk of spreading infection.

Encourage patients to consult a doctor before using this product if they have any of the following conditions: heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate gland.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at room temperature to maintain its integrity and efficacy. Proper handling should be observed to ensure optimal conditions are met throughout the storage period.

Additional Clinical Information

The route of administration for the medication is nasal. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. Additionally, it is important to inform patients that using this container by more than one person may lead to the spread of infection.

Drug Information (PDF)

This file contains official product information for Kroger No Drip Nasal Mist Severe Congestion, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)