12 Hour Original Nasal Decongestant

Description

Sheffield Pharmaceutical's Original Nasal Spray contains Oxymetazoline HCl at a concentration of 0.05%. This formulation is designed to provide 12-hour relief from nasal congestion associated with conditions such as the common cold, hay fever, sinusitis, and upper respiratory allergies. The product is packaged in a 30 mL (1.01 FL OZ) container. The National Drug Code (NDC) for this product is 11527-140-55.

Uses and Indications

This drug is indicated for the temporary relief of nasal congestion associated with the common cold, hay fever, sinusitis, and upper respiratory allergies. It functions by shrinking swollen membranes, thereby facilitating easier breathing.

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

Dosage and Administration

For adults and 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.

For children under 6 years of age, consultation with a healthcare professional is advised prior to use.

To administer the spray, the healthcare professional should instruct the patient to squeeze the bottle quickly and firmly. It is essential that the patient does not tilt their head backwards while spraying. After use, the nozzle should be wiped clean to maintain hygiene and prevent blockage.

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

Healthcare professionals should be aware of the following warnings and precautions associated with the use of this product.

General precautions must be observed to ensure safe usage. It is imperative that patients do not exceed the recommended dosage and refrain from using the product for more than three consecutive days. Prolonged or frequent use may lead to a recurrence or worsening of nasal congestion. Patients may experience temporary discomfort, which can manifest as burning, stinging, sneezing, or an increase in nasal discharge. Additionally, it is crucial to advise patients that sharing this container with others may facilitate the spread of infection.

In the event of accidental ingestion, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay.

Healthcare professionals should instruct patients to discontinue use and consult a physician if symptoms persist, ensuring that appropriate follow-up care is provided.

Side Effects

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

Before initiating use, patients are encouraged to seek medical advice if they have a history of heart disease, high blood pressure, diabetes, thyroid disease, or if they experience difficulty urinating due to an enlarged prostate gland. These conditions may increase the risk of adverse reactions and warrant careful consideration prior to use.

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 12 Hour Original Nasal Decongestant (nasal spray). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 6 to under 12 years may receive 2 or 3 sprays in each nostril, administered no more frequently than every 10 to 12 hours. It is important to note that the total dosage should not exceed 2 doses within a 24-hour period. For children under 6 years of age, consultation with a healthcare professional is advised prior to use.

Geriatric Use

There is no specific information available regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy.

Pregnancy

Pregnant patients are advised to consult a healthcare professional prior to using this medication. The potential risks and benefits should be carefully considered, as the effects on fetal outcomes are not fully established. It is essential for women of childbearing potential to seek guidance to ensure the safety of both the mother and the developing fetus.

Lactation

Lactating mothers should consult a health professional before using this medication. There is a potential for excretion in breast milk, and consideration of infant risk is advised when using this medication while breastfeeding.

Renal Impairment

Renal impairment may necessitate dosage adjustments for patients with reduced renal function. It is essential that creatinine clearance be assessed prior to initiating therapy and periodically thereafter to ensure appropriate dosing. Additionally, patients with reduced kidney function should be monitored closely throughout the treatment course. Regular renal function tests are recommended to ensure safety in this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in clinical trials for this medication. Consequently, there is no available information regarding dosage adjustments, special monitoring requirements, or precautions 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 warranted based on clinical judgment.

Overdosage

In the absence of specific information regarding overdosage in the available sections of the drug insert, healthcare professionals are advised to exercise caution and consider general principles of management for suspected overdosage cases.

Recommended Actions In the event of an overdosage, it is essential for healthcare providers to assess the patient's clinical status and initiate appropriate supportive care. Monitoring of vital signs and symptomatic treatment should be prioritized.

Potential Symptoms While specific symptoms related to overdosage are not detailed, healthcare professionals should remain vigilant for any unusual or severe reactions that may arise, given the lack of documented information.

Management Procedures In the case of suspected overdosage, it is recommended that healthcare professionals consult local poison control centers or relevant toxicology resources for guidance on management strategies. Supportive care should be tailored to the individual patient's needs, and any necessary interventions should be implemented promptly to mitigate potential risks.

Overall, due to the absence of detailed overdosage information, a cautious and proactive approach is warranted in managing any suspected cases.

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 limits the assessment of potential risks associated with the compound in these areas.

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 if the product is swallowed. It is important to instruct patients to discontinue use and consult a doctor if symptoms persist.

Patients should be cautioned against exceeding the recommended dosage and should not use the product for more than three days. Emphasize that the product should be used only as directed, as frequent or prolonged use may lead to a recurrence or worsening of nasal congestion.

Inform patients that temporary discomfort, such as burning, stinging, sneezing, or an increase in nasal discharge, may occur during use. Additionally, healthcare providers should highlight that the use of this container by more than one person may increase the risk of spreading infection.

Before initiating treatment, patients should be encouraged to consult with their healthcare provider if they have a history of heart disease, high blood pressure, diabetes, thyroid disease, or difficulty urinating due to an enlarged prostate gland.

Storage and Handling

The product is supplied in a carton that should be retained for future reference on the full labeling. It is essential to store the product at a temperature range of 20° to 25°C (68° to 77°F) to ensure its stability and efficacy. Proper storage conditions must be maintained to preserve the integrity of the product.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for 12 Hour Original Nasal Decongestant, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)