Basic Care No Drip Nasal

Description

Oxymetazoline hydrochloride 0.05% is a nasal decongestant formulated for adult use. Each 1 fluid ounce (30 mL) bottle contains a maximum strength formulation enhanced with menthol, designed to provide fast and powerful relief from nasal congestion associated with colds and allergies. The product features a pump mist delivery system that ensures the active ingredient does not drip from the nose or down the throat, offering 12-hour 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 medication acts to shrink swollen nasal membranes, facilitating easier breathing.

There are no teratogenic or nonteratogenic effects mentioned in the available data.

Dosage and Administration

Adults and children aged 6 to under 12 years, under adult supervision, may receive 2 or 3 sprays in each nostril, administered no more frequently than every 10 to 12 hours. The total dosage must not exceed 2 doses within a 24-hour period. For children under 6 years of age, consultation with a physician is recommended prior to use.

Prior to administration, the product must be shaken well. To prepare the device for use, hold the white tabs, squeeze the grooved area of the cap firmly, and turn it counterclockwise. Before the initial use, the metered pump should be primed by firmly depressing the pump several times. For application, 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. A firm, even stroke should be used to fully depress the rim while simultaneously sniffing deeply. After use, the nozzle must be wiped clean, and the cap should be securely replaced.

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 be aware of the following warnings and precautions associated with the use of this medication.

Patients should be advised to consult a physician prior to use 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. These conditions may increase the risk of adverse effects or complications.

It is imperative to adhere strictly to the recommended dosage. 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 worsening of nasal congestion. Additionally, temporary discomfort such as burning, stinging, sneezing, or an increase in nasal discharge may occur during use.

To prevent the spread of infection, it is advised that this container not be used by more than one individual.

Patients should be instructed to discontinue use and consult a healthcare provider if symptoms persist.

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 burning, stinging, sneezing, or an increase in nasal discharge. It is important for patients to adhere to the recommended usage guidelines, as exceeding the directed dosage or using the product for more than three days may lead to a recurrence or worsening of nasal congestion.

Patients with pre-existing conditions such as heart disease, high blood pressure, thyroid disease, diabetes, or those experiencing trouble urinating due to an enlarged prostate gland should consult a healthcare professional before using this product. Additionally, if symptoms persist, patients are advised to discontinue use and seek medical advice.

For pregnant or breastfeeding individuals, it is recommended to consult a health professional prior to use. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is advised.

It is also crucial to note that the use of this container by more than one person may facilitate the spread of infection.

Drug Interactions

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

Packaging & NDC

Below are the non-prescription pack sizes of Basic Care No Drip Nasal (oxymetazoline hydrochloride). 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, and adult supervision is required during administration.

For children under 6 years of age, it is advised to consult a physician before 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, 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. It is important to assess the potential risks and benefits associated with its use during pregnancy and lactation. The safety of this medication in pregnant women has not been established, and therefore, caution is advised.

Lactation

Lactating mothers may use this medication to temporarily relieve nasal congestion associated with common cold, hay fever, and upper respiratory allergies, as well as to alleviate sinus congestion and pressure. However, the effects on breastfed infants have not been specifically studied. Therefore, healthcare professionals should weigh the benefits of treatment against potential risks when advising lactating mothers.

Renal Impairment

Patients with renal impairment should consult a healthcare professional prior to use, particularly if they experience difficulties with urination due to an enlarged prostate gland. It is essential to assess renal function and consider potential dosing adjustments or monitoring requirements based on the degree of impairment.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to 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 prescribing 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 or contact a Poison Control Center without delay. The national Poison Control Center can be reached at 1-800-222-1222.

Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved; therefore, a thorough assessment and appropriate management strategies should be implemented based on clinical presentation and the substance's pharmacological profile.

Healthcare providers are encouraged to monitor the patient closely and provide supportive care as necessary. It is imperative to follow established protocols for the management of overdosage, which may include decontamination, symptomatic treatment, and specific antidotes if applicable.

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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions reported voluntarily or through surveillance programs: temporary discomfort, including sensations of burning and stinging, sneezing, and an increase in nasal discharge. These events were noted in the context of routine postmarketing surveillance and should be considered when evaluating the overall safety profile of the product.

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. They should be cautioned 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, healthcare providers should emphasize that this product should not be shared among multiple users, as this may facilitate the spread of infection.

Before initiating use, patients should be encouraged to consult with their healthcare provider 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 packaging that includes the relevant NDC numbers. It should be stored at a temperature range of 20-25°C (68-77°F) to ensure optimal stability and efficacy. Healthcare professionals are advised to retain the carton for future reference regarding the full labeling information. Special handling requirements are not specified; however, standard precautions should be taken to maintain the integrity of the product during storage.

Additional Clinical Information

The medication is administered via the nasal route. For adults and children aged 6 to under 12 years, it is recommended to use 2 or 3 sprays in each nostril, not more frequently than every 10 to 12 hours, with a maximum of 2 doses within a 24-hour period. For children under 6 years of age, consultation with a doctor is advised prior to use.

There is no additional information available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

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

View product document (PDF)