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Maximum Strenth Nasal

Dosage form: liquid
Ingredients: Oxymetazoline Hydrochloride 0.05g in 100mL
Labeler: Walgreens
NDC Code: 0363-7003

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.

Drug Facts

Active ingredient                                            Purpose

Oxymetazoline Hydrochloride - 0.05%           Nazal Decongestant

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

MAXIMUM STRENTH NASAL 
oxymetazoline hydrochloride - 0.05% liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-7003
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Oxymetazoline Hydrochloride (OXYMETAZOLINE) Oxymetazoline Hydrochloride0.05 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
Benzalkonium Chloride 
CAMPHOR (SYNTHETIC) 
EDETATE DISODIUM 
Eucalyptol 
Glycine 
Menthol 
Polysorbate 80 
Propylene Glycol 
Sodium Chloride 
Sodium Hydroxide 
water 
Packaging
#Item CodePackage Description
1NDC:0363-7003-011 BOTTLE in 1 CARTON
122 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/15/2016
Labeler - Walgreens (008965063)
Registrant - Product Quest Mfg. (927768135)
Establishment
NameAddressID/FEIOperations
Product Quest Mfg.927768135manufacture(0363-7003), label(0363-7003)

Revised: 06/2016
 
Walgreens

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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