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NDC 71205-0383-30 Oxymethazoline HCL 0.05 mg/1 Details
Oxymethazoline HCL 0.05 mg/1
Oxymethazoline HCL is a NASAL SPRAY in the HUMAN OTC DRUG category. It is labeled and distributed by Proficient Rx LP. The primary component is OXYMETAZOLINE HYDROCHLORIDE.
MedlinePlus Drug Summary
Oxymetazoline nasal spray is used to relieve nasal discomfort caused by colds, allergies, and hay fever. It is also used to relieve sinus congestion and pressure. Oxymetazoline nasal spray should not be used to treat children younger than 6 years of age unless it is recommended by a doctor. Children 6 to 12 years of age should use oxymetazoline nasal spray carefully and under adult supervision. Oxymetazoline is in a class of medications called nasal decongestants. It works by narrowing the blood vessels in the nasal passages.
Related Packages: 71205-0383-30Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Oxymetazoline Nasal Spray
Product Information
| NDC | 71205-0383 |
|---|---|
| Product ID | 71205-383_66280863-f50b-40f0-b259-df947ebc7b8b |
| Associated GPIs | 42102040102010 |
| GCN Sequence Number | 008037 |
| GCN Sequence Number Description | oxymetazoline HCl MIST 0.05 % NASAL |
| HIC3 | Q7D |
| HIC3 Description | NOSE PREPARATIONS, VASOCONSTRICTORS(OTC) |
| GCN | 34050 |
| HICL Sequence Number | 003417 |
| HICL Sequence Number Description | OXYMETAZOLINE HCL |
| Brand/Generic | Generic |
| Proprietary Name | Oxymethazoline HCL |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Oxymethazoline HCL |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | SPRAY |
| Route | NASAL |
| Active Ingredient Strength | 0.05 |
| Active Ingredient Units | mg/1 |
| Substance Name | OXYMETAZOLINE HYDROCHLORIDE |
| Labeler Name | Proficient Rx LP |
| Pharmaceutical Class | Imidazolines [CS], Increased Sympathetic Activity [PE], Vasoconstriction [PE], Vasoconstrictor [EPC] |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | part341 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 71205-0383-30 (71205038330)
| NDC Package Code | 71205-383-30 |
|---|---|
| Billing NDC | 71205038330 |
| Package | 1 BOTTLE, SPRAY in 1 CARTON (71205-383-30) / 1 SPRAY in 1 BOTTLE, SPRAY |
| Marketing Start Date | 2019-01-10 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 96883e5f-18b5-4c1c-b984-756cb86be6ff Details
Uses
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
Directions
adults and children 6 to under 12 years of age (with adult supervision): 2 or 3 sprays in each nostril. Not more often than every 10-12 hours. Do not exceed 2 doeses in 24 hours.
children under 6 years of age: ask a doctor.
Instructions for use: Shake well before use. to open, rotate cap to align the marks. Squeeze cap on toh sides in a counter-clockwise turn and pull to remove. To spray, hold bottles with thumb at base and nozzle between first and second fingers. Without tilting the head, insert nozzle into nostril. Fully depress rim with a firm even stroke and sniff deeply. Wipe nozzle clean after use and snap cap back onto bottle.
Other information
Inactive ingredients
Warnings
Ask a doctor before use if you have
heart disease
high blood pressure
thyroid disease
diabetes
trouble urinating due to an enlarged prostate gland
When using this prduct
do not use more than directed
do not use more than 3 days. Use only as directed. Frequent or prolonged use may cause nasal congestion to recur or worsen.
temporary discomfort such as burning, stinging, sneexing, or an increased nasal discharge may occur
use of this container by more than one person may spread infection
PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
| OXYMETHAZOLINE HCL
oxymethazoline hcl spray |
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| Labeler - Proficient Rx LP (079196022) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Proficient Rx LP | 079196022 | REPACK(71205-383) , RELABEL(71205-383) | |