Active Ingredient
Oxymetazoline HCL 0.05%
Oxymethazoline Hcl Spray
FDA Label NDC 68788-7516
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Preferred Pharmaceuticals Inc. for the product Oxymethazoline Hcl (NDC 68788-7516). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, uses, otc - ask doctor, otc - stop use, otc - pregnancy or breast feeding, otc - keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Nasal decongestant
Uses
temporarily relieves nasal congestion due to:
- common cold
- hay fever
- upper respiratory allergies
temporarily relieves sinus congestion and pressure
shrinks swollen nasal membranes
Otc - Ask Doctor
Ask a doctor before use if you have
heart disease
high blood pressure
thyroid disease
diabetes
trouble urinating due to an enlarged prostate gland
Otc - Stop Use
Stop use and ask a doctor if symptoms presist
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
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
store between 20° to 25° C (68° to 77° F)
retain carton for future referance on full labeling
Inactive Ingredients
benzalkoium cjloride, dibasic sodium phosphate, edetate disodium dihydrate, monobasic sodium phosphate, polyethylene glycol, propylene glycol, povidone, purified water
Questions Or Comments?
call 516-341-0666, 8:30 am - 4:30 pm ET, Monday - Friday
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
Package Label.Principal Display Panel
NDC 68788-7516-3
Reliabel-1 Laboratories
12 Hour Decongestant Nasal Spray
Oxymetazoline HCL
Pump Mist Anti-Drip
Rapid & Powerful
Congestion Relief
12 Hour Relief
1 FL OZ (30 mL)
Relabeled By: Preferred Pharmaceuticals Inc.
Nasal Decongestant 12 Hour Spray (Carton)
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