PUBLIX MAXIMUM STRENGTH- oxymetazoline hydrochloride spray

Publix by

Drug Labeling and Warnings

Publix by is a Otc medication manufactured, distributed, or labeled by PUBLIX SUPER MARKETS, INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Oxymetazoline hydrochloride 0.05%

Purpose

Nasal Decongestant

Uses

• ▪ for the temporarily relief of nasal congestion due to the, common cold, hay fever or other 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 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

To Spray: squeeze bottle quickly and firmly. Do not tilt head backward while spraying. Wipe nozzle clean after use. Secure cap after use.

Other information

• ▪ store at room temperature

Inactive ingredients

benzalkonium chloride, benzyl alcohol, edetate disodium, polyethylene glycol, povidone, propylene glycol, purified water, sodium phosphate dibasic, sodium phosphate monobasic.

Questions or comments?

1-866-467-2748

Principal Display Panel

Publix®

NDC# 41415-715-30

Compare to the active ingredient in Afrin® original*

ORIGINAL

Nasal Spray

NASAL DECONGESTANT

OXYMETAZOLINE HCL 0.05%

12 HOUR RELIEF

MAXIMUM STRENGTH

• Fast, Powerful Congestion Relief
• For Colds & Allergies

1 FL OZ (30 mL)

IMPORTANT: Keep this carton for future reference on full labeling.

DISTRIBUTED BY

PUBLIX SUPER MARKETS, INC.,

3300 PUBLIX CORPORATE PARKWAY,

LAKELAND, FL 33811

publix.com, 1-888-267-3037

PUBLIX GUARANTEE: COMPLETE SATISFACTION OR YOUR MONEY BACK.

*This product is not manufactured or distributed by Bayer Healthcare LLC, distributer of Afrin® Original.

INGREDIENTS AND APPEARANCE

PUBLIX  MAXIMUM STRENGTH
oxymetazoline hydrochloride spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41415-715
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)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM (UNII: GR686LBA74)
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM (UNII: 3980JIH2SW)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41415-715-30	1 in 1 CARTON	05/16/2019
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	05/16/2019

Labeler - PUBLIX SUPER MARKETS, INC (006922009)