MAXIMUM STRENTH NASAL- oxymetazoline hydrochloride - 0.05% liquid

Maximum Strenth Nasal by

Drug Labeling and Warnings

Maximum Strenth Nasal by is a Otc medication manufactured, distributed, or labeled by Walgreens, Product Quest Mfg.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient                                            Purpose

Oxymetazoline Hydrochloride - 0.05%           Nazal Decongestant

PURPOSE

Uses

For the temporary relief of nasal congestion due to the common cold, hay fever or other upper respiratory allergies.

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

Do not use this product for more than 3 days. Use only as directed. Frequent or prolonged use may cause nasal congestion to recur or worsen. If symptoms persist, consult a doctor.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.

Keep out of reach of children. If product is 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 to 12 hours. Do not exceed 2 doses in any 24-hour period. Children under 6 years of age: consult a doctor.

Inactive ingredients

Benzalkonium Chloride
Camphor
Disodium EDTA
Eucalyptol
Glycine
Menthol
Polysorbate 80
Propylene Glycol
Sodium Chloride
Sodium Hydroxide
Water

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MAXIMUM STRENTH NASAL 
oxymetazoline hydrochloride - 0.05% liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0363-7003
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)
Eucalyptol (UNII: RV6J6604TK)
Glycine (UNII: TE7660XO1C)
Menthol (UNII: L7T10EIP3A)
Polysorbate 80 (UNII: 6OZP39ZG8H)
Propylene Glycol (UNII: 6DC9Q167V3)
Sodium Chloride (UNII: 451W47IQ8X)
Sodium Hydroxide (UNII: 55X04QC32I)
water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0363-7003-01	1 in 1 CARTON	07/15/2016
1		22 mL in 1 BOTTLE; 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	07/15/2016

Labeler - Walgreens (008965063)

Registrant - Product Quest Mfg. (927768135)

Establishment
Name	Address	ID/FEI	Business Operations
Product Quest Mfg.		927768135	manufacture(0363-7003) , label(0363-7003)