OXYMETHAZOLINE HCL spray

Oxymethazoline HCL by

Drug Labeling and Warnings

Oxymethazoline HCL by is a Otc medication manufactured, distributed, or labeled by Reliable 1 Laboratories. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 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

STOP USE

Stop use and ask a doctor if symptoms presist

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health professional before use.

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 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

PRINCIPAL DISPLAY PANEL

NDC: 69618-050-51

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)

INGREDIENTS AND APPEARANCE

OXYMETHAZOLINE HCL 
oxymethazoline hcl spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69618-050
Route of Administration	NASAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OXYMETAZOLINE HYDROCHLORIDE (UNII: K89MJ0S5VY) (OXYMETAZOLINE - UNII:8VLN5B44ZY)	OXYMETAZOLINE HYDROCHLORIDE	0.05 mg

Inactive Ingredients
Ingredient Name	Strength
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 (UNII: FZ989GH94E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69618-050-51	1 in 1 CARTON	01/01/2019
1		1 in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	01/01/2019

Labeler - Reliable 1 Laboratories (079718111)