DZA Brands, LLC Nasal Spray Drug Facts

Healthy Accents Nasal by

Drug Labeling and Warnings

Healthy Accents Nasal by is a Otc medication manufactured, distributed, or labeled by DZA Brands LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HEALTHY ACCENTS NASAL- phenylephrine hydrochloride spray 
DZA Brands LLC

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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DZA Brands, LLC Nasal Spray Drug Facts

Active ingredient

Phenylephrine hydrochloride 1%

Purpose

Nasal decongestant

Uses

  • temporarily relieves nasal congestion due to:
  • common cold
  • hay fever
  • upper respiratory allergies

Warnings

Ask a doctor before use if you have

  • heart disease
  • diabetes
  • thyroid disease
  • high blood pressure
  • 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. Frequent or prolonged use may cause nasal congestion to come back or get worse.
  • use only as directed
  • 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. (1-800-222-1222)

Directions

  • adults and children 12 years and over: 2 or 3 sprays in each nostril not more often than every 4 hours
  • children under 12 years: ask a doctor
  • Use instructions: with head in a normal, upright position, put atomizer tip into nostril. Squeeze bottle with firm, quick pressure while inhaling. Wipe nozzle clean after each use.

Other information

  • store at 20°-25°C (68°-77°F)

Inactive ingredients

benzalkonium chloride solution, benzyl alcohol, boric acid, purified water, sodium borate

Questions or comments?

1-866-322-2439

Principal Display Panel

fast acting

nasal spray

4 hour – nasal decongestant

phenylephrine hydrochloride 1%

nasal congestion

swollen nasal membranes

sinus congestion

sinus pressure

Compare to 4-Way® Fast Acting Nasal Spray active ingredient

1 FL OZ (30mL)

Healthy Accents Nasal Spray Image
HEALTHY ACCENTS NASAL 
phenylephrine hydrochloride spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 55316-648
Route of AdministrationNASAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE1 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
BORIC ACID (UNII: R57ZHV85D4)  
SODIUM BORATE (UNII: 91MBZ8H3QO)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 55316-648-101 in 1 CARTON02/11/200811/30/2019
130 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34102/11/200811/30/2019
Labeler - DZA Brands LLC (090322194)

Revised: 11/2019
Document Id: 85f662b6-12f5-45ce-8d92-7d495ba8de62
Set id: 85b704bd-2674-4e5f-be14-a42b9f84e478
Version: 3
Effective Time: 20191118
 
DZA Brands LLC