Oxymetazoline HydrochlorideNasal Decongestant 12-Hour Spray

Drug Labeling and Warnings

Drug Details [pdf]

NASAL RELIEF 12-HOUR- oxymetazoline hydrochloride spray 
Rugby Laboratories

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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Oxymetazoline Hydrochloride
Nasal Decongestant 12-Hour Spray

Drug Facts

Active ingredient

Oxymetazoline hydrochloride 0.05%

Purpose

Nasal decongestant

Uses

• temporary relief of nasal congestion
  • due to the common cold
  • due to hay fever or other upper respiratory allergies
  • associated with sinusitis
• temporarily restores freer breathing through the nose

Warnings

Do not exceed recommended dosage

This product may cause temporary discomfort such as burning, stinging, sneezing, or an increase in nasal discharge. The use of this container by more than one person may spread infection.

Do not use

• for more than 3 days

Ask a doctor before use if you have

• heart disease
• high blood pressure
• thyroid disease
• diabetes
• difficulty in urination due to enlargement of the prostate gland

When using this product

• frequent or prolonged use may cause nasal congestion to recur or worsen
• do not use more than directed
• there may be temporary discomfort such as burning, stinging, sneezing or an increase in nasal discharge
• use only as directed as frequent or prolonged use may cause nasal congestion to recur or worsen
• infection may spread if container is used by more than one person

Stop use and ask a doctor if

• symptoms persist

If pregnant 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 to 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: do not use
• To spray: squeeze the bottle quickly and firmly. Do not tilt head backward while spraying. Wipe nozzle clean after use.

Inactive ingredients

benzalkonium chloride, dibasic sodium phosphate (anhydrous), edetate disodium (dihydrate), monobasic sodium phosphate (monohydrate), purified water, sodium chloride, sorbitol

Questions?

Call 1-866-645-2158

Distributed by:
Rugby Laboratories
Livonia, MI 48150  USA

PRINCIPAL DISPLAY PANEL - 15 mL Bottle Carton

Compare to the
active ingredient
in Afrin ®*

Nasal
Decongestant
12- Hour Spray

Oxymetazoline
Hydrochloride 0.05%

Maximum Strength

• Fast Acting
• Up To 12 Hours Relief

NASAL RELIEF  12-HOUR
oxymetazoline hydrochloride spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0536-5005
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)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN)
WATER (UNII: 059QF0KO0R)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SORBITOL (UNII: 506T60A25R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0536-5005-72	1 in 1 CARTON	10/29/2012	10/31/2017
1		15 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	10/29/2012	10/31/2017

Labeler - Rugby Laboratories (079246066)

Revised: 9/2019

Document Id: 50991b51-647e-4603-8ea5-7d1dbd06c4fd

34390-5

Set id: 078de5f2-6f0b-4f97-82cf-c0d150437291

Version: 4

Effective Time: 20190906