OTC Medication Information: EB306 NASAL DECONGESTANT

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.

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
(click image for full-size original)
EB306 NASAL DECONGESTANT
phenylephrine hydrochloride spray
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:53304-0306
Route of Administration NASAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE 21.73 mg in 15 mL
Inactive Ingredients
Ingredient Name Strength
ALCOHOL
AMARANTHUS VIRIDIS LEAF
PORK SIDE BACON, CURED FAT
GAULTHERIA PROCUMBENS LEAF
GLYCERIN
PLATOSTOMA PALUSTRE WHOLE
PEPPERMINT
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:53304-0306-1 1 BOTTLE, SPRAY in 1 BOX contains a BOTTLE, SPRAY
1 15 mL in 1 BOTTLE, SPRAY This package is contained within the BOX (53304-0306-1)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part341 11/01/2012
Labeler — EMINENCE BIOTECH CORPORATION LIMITED (078531141)

Revised: 03/2018 EMINENCE BIOTECH CORPORATION LIMITED

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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