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Epinephrine Nasal Solution Prescribing Information

Package insert / product label
Generic name: epinephrine hydrochloride
Dosage form: nasal solution

Warnings and Precautions

Caution: Administer with caution to elderly people. Do not use if high blood pressure, heart disease, diabetes, or thyroid disease is present unless directed by a physician. If prompt relief is not obtained, consult a physician. Administer to pediatric patients under six years of age only on the advice of a physician.

Indications and Usage for Epinephrine Nasal Solution

For use as a nasal decongestant.Apply locally as drops or spray, or with a sterile swab, as required.

Instructions for diluting

To make Epinephrine Chloride SolutionEpinephrine Chloride Solution 1 mg/mLIsotonic Salt Solution
0.5 mg/mL 1 mL 1 mL
0.2 mg/mL 1 mL 4 mL
0.1 mg/mL 1 mL 9 mL

Epinephrine Nasal Solution Dosage and Administration

Each mL contains 1 mg Epinephrine as the hydrochloride, dissolved in isotonic sodium chloride solution with 0.5% chlorobutanol (chloroform derivative) as a preservative and not more than 0.05% sodium metabisulfite as an antioxidant.EPINEPHrine nasal solution, USP must not be brought into contact with oxidizing agents.The solution is also quickly decomposed by iron salts and alkalies.

Adverse Reactions/Side Effects

To report SUSPECTED ADVERSE REACTIONS, contact BPI Labs, LLC at 1-727-471-0850 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

How is Epinephrine Nasal Solution supplied

EPINEPhrine Chloride Solution 10mg/10ml (1mg/1ml) in 10ml vial.NDC 54288-123-01

This product is sterile until opened.

Keep this and all drugs out of the reach of children.

Store between 20° to 25°C (68° to 77°F). (See USP Controlled Room Temperature.) Do not refrigerate or freeze, Protect from light.

Do not use if cap seal is broken or missing.

Manufactured by:

BPI Labs, LLC

Largo, FL 33773.

Rev: 08/2020

LI123C-01

R-2005

Principal Display Pannel

Manufactured by:

BPI Labs, LLC

Largo, FL 33773.

Rev: 08/2020

LI123C-01

R-2005

box
label
EPINEPHRINE CHLORIDE SOLUTION
epinephrine nasal solution solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:54288-123
Route of AdministrationNASAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
EPINEPHRINE HYDROCHLORIDE (UNII: WBB047OO38) (EPINEPHRINE - UNII:YKH834O4BH) EPINEPHRINE HYDROCHLORIDE1 mg in 1 mL
Inactive Ingredients
Ingredient NameStrength
ISOTONIC SODIUM CHLORIDE SOLUTION (UNII: VR5Y7PDT5W)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
CHLOROBUTANOL (UNII: HM4YQM8WRC)
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54288-123-0110 mL in 1 BOX; Type 0: Not a Combination Product09/30/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other09/30/2020
Labeler - BPI Labs, LLC (078627620)
Establishment
NameAddressID/FEIBusiness Operations
BPI Labs, LLC078627620manufacture(54288-123) , label(54288-123)