EB306 NASAL DECONGESTANT- phenylephrine hydrochloride spray 
EMINENCE BIOTECH CORPORATION LIMITED

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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EB306 NASAL DECONGESTANT

Drug Facts

Active ingredient

Phenylephrine Hydrochloride 0.125%

Purpose

Nasal Decongestant

Uses

For the temporary relief of nasal congestion due to hay fever or other upper respiratory allergies (allergic rhinitis)

Warnings

Do not exceed recommended dosage.

This product may cause temporary discomfort such as burning, sting, sneezing, or an increase in nasal discharge. The use of this container by more than one person may spread infection.

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.
  • if you have heart disease, high blood pressure, thyroid disease, diabetes, or difficulty in urination due to enlargement of the prostate gland unless directed by a doctor.

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 2 to under 6 years of age

2 to 3 drops or sprays (1 cc) under each nostril, and rub dry. Repeat no more than every 6 hours.

Children under 2 years of age

Consult a doctor.

Other information

Store at cool place (room temperature) away from heat and light sources

Inactive ingredients

Alcohol, Amaranthus Viridis Leaf, Animal Fat, Gaultheria Procumbens (Wintergreen) Leaf Extract, Glycerin, Mesona Chinensis Whole, Peppermint Extract, Water.

Questions?

Call 1-562-207-8624

Distributed by:

EMINENCE BIOTECH CORPORATION LIMITED

3411 SILVERSIDE ROAD, RODNEY BUILDING #104
WILMINGTON DE19810 NEW CASTLE COUNTY, USA

PRINCIPAL DISPLAY PANEL - 15mL Bottle Carton

EB
Eminence
Biotech

EB306

Nasal Decongestant
Allergic Rhinitis Relief

0.5 FL OZ(15mL)
NDC 53304-03061

PRINCIPAL DISPLAY PANEL - 15mL Bottle Carton
EB306 NASAL DECONGESTANT 
phenylephrine hydrochloride spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53304-0306
Route of AdministrationNASAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE21.73 mg  in 15 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
AMARANTHUS VIRIDIS LEAF (UNII: 7T0WZ76K1T)  
PORK SIDE BACON, CURED FAT (UNII: 6E710H379S)  
GAULTHERIA PROCUMBENS LEAF (UNII: 2125M16OWN)  
GLYCERIN (UNII: PDC6A3C0OX)  
PLATOSTOMA PALUSTRE WHOLE (UNII: FE70D062O9)  
PEPPERMINT (UNII: V95R5KMY2B)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53304-0306-11 in 1 BOX11/01/2012
115 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34111/01/2012
Labeler - EMINENCE BIOTECH CORPORATION LIMITED (078531141)

Revised: 3/2018
Document Id: 2b5ffa7e-257b-47b9-b8d4-4fc45d3453b1
Set id: 887562bf-1b9d-4980-8859-5d8d8a723994
Version: 2
Effective Time: 20180320
 
EMINENCE BIOTECH CORPORATION LIMITED