ORIGINAL NASAL PUMP MIST NO DRIP- oxymetazoline hydrochloride spray

ORIGINAL Nasal PUMP MIST by

Drug Labeling and Warnings

ORIGINAL Nasal PUMP MIST by is a Otc medication manufactured, distributed, or labeled by WinCo FOODS, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Oxymetazoline hydrochloride 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 so you can breathe more freely

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 product

• ▪ do not use more than directed
• ▪ 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
• ▪ 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 right away at 1-800-222-1222.

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: ask a doctor

Shake well before use. Push down cap while turning counter-clockwise and remove cap. Remove clip under rim. Before using the first time, prime metered pump by depressing pump firmly several times. To spray, hold bottle with thumb at base and nozzle rim between first and second fingers. Without tilting head, insert nozzle into nostril. Fully depress rim with a firm, even stroke and sniff deeply. Wipe nozzle clean after use. Replace clip under rim and secure cap after use.

Other information

• ▪ store at temperature

Inactive ingredients

benzalkonium chloride, benzyl alcohol, edetate disodium, microcrystalline cellulose and carboxymethyl cellulose sodium, polyethylene glycol, povidone, purified water, sodium phosphate dibasic, sodium phosphate monobasic, xanthan gum.

Questions?

Call 800-824-1706

Monday-Friday 9am-4pm MST

Principal Display Panel

NDC: 67091-326-30

*Compare to the active ingredient in AFRIN® No-Drip Original

WinCo® FOODS

ORIGINAL Nasal Spray

Pump Mist

Anti-Drip

OXYMETAZOLINE HCL

NASAL DECONGESTANT

Fast and Powerful Relief from Nasal Congestion

12 Hour Relief

1 FL OZ (30 mL)

*This product is not manufactured and distributed by Bayer, distributor of AFRIN® No Drip original.

TAMPER EVIDENT: DO NOT USE IF PRINTED SEAL OVER CAP IS TORN OR MISSING

IMPORTANT: Keep this carton for future reference on full labeling

DISTRIBUTED BY:

WINCO FOODS LLC,

BOISE, ID 83704

The Supermarket Low Price Leader

100% Satisfaction Guarantee

Comments & Questions?

800-824-1706.www.wincofoods.com

INGREDIENTS AND APPEARANCE

ORIGINAL NASAL PUMP MIST  NO DRIP
oxymetazoline hydrochloride spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67091-326
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 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
BENZYL ALCOHOL (UNII: LKG8494WBH)
EDETATE DISODIUM (UNII: 7FLD91C86K)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
POVIDONE K90 (UNII: RDH86HJV5Z)
WATER (UNII: 059QF0KO0R)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS (UNII: KH7I04HPUU)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67091-326-30	1 in 1 CARTON	08/01/2018
1		30 mL 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	08/01/2018

Labeler - WinCo FOODS, LLC (056098817)