REXALL SINUS NASAL PUMP MIST- oxymetazoline hydrochloride 0.05% liquid

Rexall Sinus Nasal Pump Mist by

Drug Labeling and Warnings

Rexall Sinus Nasal Pump Mist by is a Otc medication manufactured, distributed, or labeled by Dollar General, Product Quest Mfg. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients                                        Purpose

Oxymetazoline Hydrochloride 0.05%            Nesal Decongestant

PURPOSE

Uses

temporarily relief nasal decongestion due to:
- common cold
- hay fever
- upper respiratory allergies
- shrinks swollen membranes
- temporarily restores freer breathing through the nose

WARNINGS

Do not use this product if person has heart disease, high blood pressure, thyroid disease, diabetes, or if adult has difficulty in urination due to enlargement of the prostate gland unless directed by a doctor.

When using this product
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

Stop use and ask doctor if

Symptoms persist

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

Keep out of reach of the children

DOSAGE & ADMINISTRATION

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: consult a doctor

shake well before each use. Before using for the first time remove the protective cap from the tip and prime mitered pump by depressing pump firmly several times. To remove the cap, squeeze cap at the base on opposite sides on the two smooth impressions with fingers. While squeezing, twist cap counterclockwise to remove. Remove clip and press down to use. Refer to directions on top of each cap. To reapply cap, turn cap on pump clockwise until it locks. To spray, hold bottle with thumb at base and nozzle between first and second flingers. Without tilting head, insert nozzle into nostril. Fully depress rim with a firm, even stroke and sniff deeply. Wipe nozzle clean after use.

Inactive ingredients

Benzalkonium Chloride
Camphor
Disodium EDTA
Disodium Phosphate
Eucalyptol
Menthol
Polysorbate 20
Propylene Glycol
Sodium Phosphate
Water

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

REXALL SINUS NASAL PUMP MIST 
oxymetazoline hydrochloride 0.05% liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55910-778
Route of Administration	TOPICAL

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)
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
EUCALYPTOL (UNII: RV6J6604TK)
Menthol (UNII: L7T10EIP3A)
Polysorbate 20 (UNII: 7T1F30V5YH)
Propylene Glycol (UNII: 6DC9Q167V3)
Sodium Phosphate (UNII: SE337SVY37)
Water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55910-778-01	30 mL in 1 PACKAGE; Type 0: Not a Combination Product	12/21/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	12/21/2015

Labeler - Dollar General (068331990)

Registrant - Product Quest Mfg (927768135)

Establishment
Name	Address	ID/FEI	Business Operations
Product Quest Mfg		927768135	manufacture(55910-778) , label(55910-778)