Drug Factsactive Ingredient
Oxymetazoline HCl 0.05%
Oxymetazoline Hcl 0.05% Spray
FDA Label NDC 85786-205
14 label sections · Submitted to the FDA by Farmacias De Similares Tx Llc · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Farmacias De Similares Tx Llc for the product Oxymetazoline Hcl 0.05% (NDC 85786-205). 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 drug factsactive ingredient, purpose, uses, warnings, ask a doctor before use if you have, when using this product, stop use and ask a doctor if, if pregnant or breast-feeding,, 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 so you can breathe more freely
Warnings
.
Ask A Doctor Before Use If You Have
■ heart disease
■ high blood pressure
■ diabetes
■ thyroid disease
■ trouble urinating due to an enlarged prostate gland
When Using This Product
■ do not exceed recommended dosage
■ do not use for 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, sneezing, or an increase in nasal discharge may occur
■ the use of this container by more than one person may spread infection
Stop Use And Ask A Doctor If
symptoms persist
If Pregnant Or Breast-Feeding,
ask a health professional before use.
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) 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 to 12 hours. Do not exceed 2 doses in any 24-hour period.
■ children under 6 years of age: consult a doctor
To spray, squeeze bottle quickly and firmly. Do not tilt head backward while spraying. Wipe nozzle clean after use.
Other Information
■ store between 20 to 25 °C (68 to 77 °F)
■ retain carton for future reference on full labeling
Inactive Ingredients
benzalkonium chloride solution, edetate disodium, polyethylene glycol, povidone, propylene glycol, purified water, sodium phosphate monobasic, sodium phosphate dibasic
Questions Or Comments?
855-280-1079
Principal Display Panel
NDC: 85786-205-01
DR. SIMI
Nasal Spray
Oxymetazoline
HCl 0.05%
Nasal Decongestant
Congestion Relief
12 Hour Relief
1 fl oz (30 mL)
DO NOT USE IF SEAL OVER CAP IMPRINTED “SEALED FOR YOUR PROTECTION” IS TORN OR MISSING
IMPORTANT: KEEP THIS CARTON FOR FUTURE REFERENCE ON FULL LABELING
Distributed by:
FARMACIAS DE SIMILARES TX LLC
800 Brazos St Ste 260, Austin, TX, 78701, USA
[email protected]
www.drsimi.com
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