OXYMETHAZOLINE HCL- oxymethazoline hcl spray 
Preferred Pharmaceuticals Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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12 Hour Decongestant Nasal Spray

Drug Facts

Active ingredient

Oxymetazoline HCL 0.05%

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

Ask a doctor before use if you have

heart disease

high blood pressure

thyroid disease

diabetes

trouble urinating due to an enlarged prostate gland

Stop use and ask a doctor if symptoms presist

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 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 20º to 25º C (68º to 77º 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

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
OXYMETHAZOLINE HCL 
oxymethazoline hcl spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68788-7516(NDC:69618-050)
Route of AdministrationNASAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OXYMETAZOLINE HYDROCHLORIDE (UNII: K89MJ0S5VY) (OXYMETAZOLINE - UNII:8VLN5B44ZY) OXYMETAZOLINE HYDROCHLORIDE0.05 mg
Inactive Ingredients
Ingredient NameStrength
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS (UNII: KH7I04HPUU)  
EDETATE SODIUM (UNII: MP1J8420LU)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
WATER (UNII: 059QF0KO0R)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68788-7516-31 in 1 CARTON02/11/2020
11 in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34102/11/2020
Labeler - Preferred Pharmaceuticals Inc. (791119022)
Registrant - Preferred Pharmaceuticals Inc. (791119022)
Establishment
NameAddressID/FEIBusiness Operations
Preferred Pharmaceuticals Inc.791119022RELABEL(68788-7516)

Revised: 8/2023
Document Id: d43ec6a1-6889-4f85-8edd-d922ccf74488
Set id: cebf4a9c-b5c6-4ad8-ab7e-9bd3a80678c4
Version: 4
Effective Time: 20230814
 
Preferred Pharmaceuticals Inc.