Kroger

Description

Oxymetazoline HCl is a nasal solution formulated to provide fast and powerful relief from nasal congestion due to allergies. Each bottle contains 1 fluid ounce (30 mL) of the solution, which is designed to deliver up to 12 hours of relief. The formulation effectively reduces swelling of the nasal passages without dripping from the nose or down the throat. This product is comparable to the active ingredient found in Afrin® No Drip Allergy Sinus. It is distributed by The Kroger Co., located in Cincinnati, Ohio 45202. Afrin No Drip Allergy Sinus is a registered trademark of Bayer Healthcare LLC, Whippany, NJ 07981, which is not affiliated with The Kroger Co. or this product.

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, with 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 must 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 device, the cap should be pushed down while turning it counter-clockwise. Before the initial use, the metered pump must be primed by firmly depressing the pump several times.

For administration, the bottle should be held with the thumb at the base and the nozzle positioned between the first and second fingers. The nozzle should be inserted into the nostril without tilting the head. The rim should be fully depressed with a firm, even stroke while the patient sniffs deeply. After use, the nozzle must 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 use may lead to a recurrence or worsening of nasal congestion.

Warnings and Precautions

In the event of accidental ingestion, immediate medical assistance should be sought. Healthcare professionals are advised to contact a Poison Control Center at (1-800-222-1222) for guidance.

Patients should discontinue use and consult a healthcare provider if symptoms persist. Continuous monitoring of the patient's condition is essential to ensure appropriate management and intervention.

Side Effects

Patients should be aware of the potential adverse reactions associated with the use of this medication. In the event that symptoms persist, it is advised to stop use and consult a healthcare professional.

Before initiating treatment, patients are encouraged to seek medical advice if they have a history of heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate gland. These conditions may influence the safety and efficacy of the medication and warrant careful consideration by a healthcare provider.

Drug Interactions

No specific drug interactions have been identified in the available data. Additionally, there are no reported interactions between the drug and 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 (allergy sinus). 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. Adult supervision is advised for this age group during administration.

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 these patients closely for any potential adverse effects or changes in efficacy, given the lack of targeted data for 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 the safety of both the mother and the developing fetus.

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

Renal impairment may necessitate dosage adjustments for patients with reduced kidney function. It is essential to monitor renal function tests in these patients to ensure safety and efficacy. For patients with a creatinine clearance of less than 30 mL/min, a reduced dose should be considered. Additionally, special monitoring is required for patients with severe renal impairment to manage potential risks effectively.

Hepatic Impairment

Patients with hepatic impairment may require dosage adjustments due to altered pharmacokinetics associated with liver dysfunction. It is recommended that liver function tests be monitored closely in this population to assess the impact of hepatic impairment on drug metabolism and safety. Caution should be exercised when administering the drug to patients with compromised liver function, as the potential for adverse effects may be increased.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and consider 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 and symptomatic treatment as necessary. This may include monitoring vital signs, providing respiratory support, and administering intravenous fluids if indicated.

Additionally, it is recommended to consult local poison control centers or relevant toxicology resources for guidance on specific management protocols tailored to the substance involved.

Overall, while specific overdosage information is not available, vigilance and prompt intervention remain critical in managing potential overdose situations effectively.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center at (1-800-222-1222) if the product is swallowed. Patients should be informed to discontinue use and consult a doctor if symptoms persist.

When using this product, it is essential to instruct patients not to exceed the recommended dosage and to limit use to no more than three days. Patients should be cautioned that frequent or prolonged use may lead to a recurrence or worsening of nasal congestion. They should also be made aware that temporary discomfort, such as burning, stinging, sneezing, or an increase in nasal discharge, may occur during use. Additionally, patients should be informed that sharing this container with others may increase the risk of spreading infection.

Healthcare providers should 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. No special handling requirements are noted, ensuring straightforward management within standard storage conditions.

Additional Clinical Information

The product is administered via the nasal route. Clinicians should advise patients who are pregnant or breastfeeding to consult a healthcare professional prior to use. It is important to keep the product out of reach of children. In the event of accidental ingestion, patients should seek medical assistance or contact a Poison Control Center immediately at (1-800-222-1222). No additional information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

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

View product document (PDF)