NASAL- oxymetazoline hydrochloride spray 
REMEDYREPACK INC.

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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MAJOR ®

Soothing - 12 Hour

NASAL

DECONGESTANT

Spray

Drug Facts

Active ingredient

Oxymetazoline hydrochloride 0.05%

Purpose

Nasal decongestant

Uses

  • for the temporary relief of nasal congestion due to the common cold, hay fever or other upper respiratory allergies
  • temporarily relieves sinus congestion and pressure
  • shrinks swollen membranes so you can breathe more freely

Warnings

Ask a doctor before use if you have

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to 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.
  • temporary discomfort such as burning, stinging, sneezing, or an increase in nasal discharge may occur
  • the use of this container by more than one person may spread infection
  • frequent or prolonged use may cause nasal congestion to recur or worsen

Stop use and ask 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 often than every 10 to 12 hours
  • do not exceed 2 doses within any 24-hour period
  • children under 6 years of age: consult a doctor

Before using the first time, remove the protective cap from the tip. To spray, hold bottle between the thumb and first and second fingers. Without tilting head, insert nozzle into nostril. Squeeze the bottle quickly and firmly. Wipe nozzle clean after use.

Other information

  • store between 20° to 25° C (68° to 77° F)

Inactive ingredients

benzalkonium chloride, benzyl alcohol, dibasic sodium phosphate, edetate disodium, hydrochloric acid, monobasic sodium phosphate, polyethylene glycol 1450, povidone, propylene glycol, purified water

Questions?

To Report Adverse Drug Event Call: (800) 616-2471

Distributed by:
MAJOR ® PHARMACEUTICALS
17177 N Laurel Park Drive, Suite 233
Livonia, Ml 48152 USA

DRUG: Nasal

GENERIC: Oxymetazoline Hydrochloride

DOSAGE: SPRAY

ADMINSTRATION: NASAL

NDC: 49349-876-15

PACKAGING: 15 mL in 1 BOTTLE, SPRAY

ACTIVE INGREDIENT(S):

  • Oxymetazoline Hydrochloride 5g in 100mL

INACTIVE INGREDIENT(S):

  • Benzyl Alcohol
  • Sodium Phosphate, Monobasic, Unspecified Form
  • Povidone, Unspecified
  • Hydrochloric Acid
  • Sodium Phosphate, Dibasic, Unspecified Form
  • Benzalkonium Chloride
  • Edetate Disodium
  • Polyethylene Glycol 1450
  • Propylene Glycol
  • Water

Remedy_Label

NASAL 
oxymetazoline hydrochloride spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49349-876(NDC:0904-5711)
Route of AdministrationNASAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OXYMETAZOLINE HYDROCHLORIDE (UNII: K89MJ0S5VY) (OXYMETAZOLINE - UNII:8VLN5B44ZY) OXYMETAZOLINE HYDROCHLORIDE5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM (UNII: GR686LBA74)  
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM (UNII: 3980JIH2SW)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
HYDROCHLORIC ACID (UNII: QTT17582CB)  
POLYETHYLENE GLYCOL 1450 (UNII: OJ4Z5Z32L4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49349-876-1515 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product11/17/201402/22/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34111/17/201402/22/2018
Labeler - REMEDYREPACK INC. (829572556)

Revised: 11/2018
Document Id: 79b87621-833b-3a37-e053-2a91aa0ab4c3
Set id: c8c8f3f1-c70f-4a25-9430-7e7b6b4528db
Version: 4
Effective Time: 20181102
 
REMEDYREPACK INC.