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EMINENCE BIOTECH CORPORATION LIMITED
3411 SILVERSIDE ROAD, RODNEY BUILDING #104
WILMINGTON DE19810 NEW CASTLE COUNTY, USA
Eb306 Nasal Decongestant
FDA Label NDC 53304-0306
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Eminence Biotech Corporation Limited for the product Eb306 Nasal Decongestant (NDC 53304-0306). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, active ingredient, purpose, uses, otc - do not use, otc - pregnancy or breast feeding, keep out of reach of children., adults and children 2 to under 6 years of age, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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)
Otc - Do Not Use
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.
Otc - Pregnancy Or Breast Feeding
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.
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
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)
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