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OXYMETAZOLINE HYDROCHLORIDE by Zydus Pharmaceuticals (USA) Inc.

Dosage form: spray, metered
Ingredients: OXYMETAZOLINE HYDROCHLORIDE 0.5mg in 1mL
Labeler: Zydus Pharmaceuticals (USA) Inc.
NDC Code: 68382-418

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.

Oxymetazoline Hydrochloride Concentrated Vapor Nasal Spray, 3/4 FL OZ (22 mL)

ACTIVE INGREDIENT

Oxymetazoline hydrochloride 0.05%

PURPOSE

Nasal decongestant

USES
  • Temporarily relieves nasal congestion due to:

                                   ■ a cold ■ hay fever ■ upper respiratory allergies

  • promotes nasal and sinus drainage
  • temporarily relieves sinus congestion and pressure
  • helps clear nasal passages; shrinks swollen membranes

WARNINGS

Ask a doctor before use if you have

■ heart disease ■ high blood pressure ■ thyroid disease ■ diabetes

■ 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.

Directions
  • adults and children 6 to under 12 years of age (with adult supervision):

2 or 3 sprays in each nostril not more 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.

Shake well before use. Before using the first time, remove the protective cap from the tip and prime metered pump by depressing firmly several times. To spray, hold bottle with thumb at base and nozzle between first and second fingers. Without tilting head, insert nozzle into nostril. Fully depress pump all the way down with a firm even stroke and sniff deeply. Wipe nozzle clean after use.

Other information
  • Store between 20º - 25ºC (68º - 77ºF)
  • retain carton for future reference on full labeling

Inactive ingredients

benzalkonium chloride solution, camphor, edetate disodium, eucalyptol, glycin, menthol, polyethylene glycol, polysorbate 80, propylene glycol, purified water, sodium chloride, sodium hydroxide.

Manufactured by:

Cadila Healthcare Ltd.

Ahmedabad, India

Distributed by:

Zydus Pharmaceuticals USA Inc.

Pennington, NJ 08534

Rev.: 05/11

Revision Date: 05/31/2011

Container and Carton Labels

NDC 68382-418-07

Oxymetazoline Hydrochloride Concentrated Vapor Nasal Spray, ¾ FL OZ (22 mL)

Rx only

Zydus

OXYMETAZOLINE HYDROCHLORIDE 
oxymetazoline hydrochloride spray, metered
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68382-418
Route of AdministrationNASALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OXYMETAZOLINE HYDROCHLORIDE (OXYMETAZOLINE) OXYMETAZOLINE HYDROCHLORIDE0.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
EDETATE DISODIUM 
EUCALYPTOL 
GLYCINE 
POLYETHYLENE GLYCOL 
POLYSORBATE 80 
PROPYLENE GLYCOL 
SODIUM CHLORIDE 
SODIUM HYDROXIDE 
WATER 
BENZALKONIUM CHLORIDE 
MENTHOL 
CAMPHOR (NATURAL) 
Product Characteristics
ColorWHITE (COLORLESS) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:68382-418-071 INHALER (INHALER) in 1 CARTON
122 mL in 1 INHALER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34109/24/2009
Labeler - Zydus Pharmaceuticals (USA) Inc. (156861945)
Registrant - Zydus Pharmaceuticals (USA) Inc. (156861945)
Establishment
NameAddressID/FEIOperations
Cadila Healthcare Limited918596198Analysis, Manufacture

 
Zydus Pharmaceuticals (USA) Inc.

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Medically reviewed on May 25, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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