Label: EB306 NASAL DECONGESTANT- phenylephrine hydrochloride spray

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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 Label Information

Updated March 20, 2018

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  • SPL UNCLASSIFIED SECTION

    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

  • SPL UNCLASSIFIED SECTION

    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
  • INGREDIENTS AND APPEARANCE
    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)
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