Flunisolide (Page 3 of 3)

DIRECTIONS FOR USE

A patient leaflet of instructions accompanies each package of Flunisolide Nasal Solution.

WARNING

Do not spray in eyes.

HOW SUPPLIED

Flunisolide Nasal Solution, USP 0.025% is supplied in a nasal pump dispenser with dust cover and with patient instructions in the following size:

25 mL bottle – NDC 24208-344-25

Each 25 mL Flunisolide Nasal Solution spray bottle contains 6.25 mg (0.25 mg/mL), 200 metered sprays of flunisolide.

Storage

Store between 15°-25°C (59°-77°F).

KEEP OUT OF REACH OF CHILDREN.

Bausch + Lomb, a division of
Valeant Pharmaceuticals North America LLC
Bridgewater, NJ 08807 USA
©Bausch & Lomb Incorporated

Revised: June 2016

9277302 (Folded)

9277402 (Flat)

Patient Instructions

PHARMACIST — DETACH HERE AND GIVE INSTRUCTIONS TO PATIENT

Flunisolide Nasal Solution, USP 0.025%

HOW TO USE YOUR NASAL PUMP UNIT –

Your nasal spray unit with the pump requires no assembly. Just follow the simple instructions below.

IMPORTANT INFORMATION ON FLUNISOLIDE NASAL SOLUTION:

1. You should use Flunisolide Nasal Solution at regular intervals since its effectiveness depends on its regular use (see below).

2. It may take 1-2 weeks before full relief is obtained.

3. You should contact your physician if symptoms do not improve, if the condition worsens, or if sneezing, nasal irritation, or bleeding occurs.

4. You should contact your physician if you know you have been exposed to chickenpox or measles.

To prime nasal pump unit (Illustrated direction)Parts of nasal spray unit with the preassembled pump.

TO PRIME:

1. Remove the dust cover. Put two fingers on “shoulders” of pump unit, and place thumb on bottom of bottle. Push bottle with thumb FIRMLY and QUICKLY 5-6 times or until a fine spray appears. Now your pump is primed. You must prime the pump unit again if you have not used it for 5 days or more, or if you have disassembled it for cleaning.

2. If the solution is delivered in a stream of liquid, it may fail to provide maximum benefit and cause some discomfort. A fine mist can be produced only by a rapid and firm pumping action.

3. Once your pump is primed, it‘s ready to use.

NOTE: Keep dust cover on the pump unit when not in use.

PHARMACIST — DETACH HERE AND GIVE INSTRUCTIONS TO PATIENT

TO USE:

1. Gently blow nose to clear nostrils. If nose is blocked, use medicine your doctor has recommended to open nasal passages.

Gently blow nose to clear (Illustrated direction)

2. Remove the dust cover. Be sure the pump unit is primed.

Remove the dust cover (Illustrated direction)

3. Place the spray tip into one nostril (tip should not reach far into nose).

Place the spray tip into one nostril (Illustrated direction)

Bend head forward so spray will aim toward the back of the nose.

4. Hold pump as shown, resting back of index finger against upper lip.

BE CAREFUL THAT FINGERS DO NOT SLIP OFF THE PUMP AS YOU SPRAY.

5. Point the tip toward the BACK and OUTER SIDE of the nose. Close other nostril with finger. Pump the spray by pushing bottle with thumb FIRMLY and QUICKLY and sniff gently at the same time. Your doctor will tell you whether to pump once or twice in each nostril.

Hold pump as shown (Illustrated direction)

6. After spraying in nostril, remove unit from nose and bend head back for a few seconds to let spray spread over back of nose.

After spraying in nostril, remove unit from nose and bend head back for a few seconds (Illustrated direction)

7. Repeat Steps 5 and 6 in other nostril. You may feel brief burning or stinging after using the spray.

8. Keep dust cover on the pump unit when not in use.

Keep dust cover on the pump unit when not in use (Illustrated direction)

TO CLEAN:

1. If spray nozzle becomes clogged, DO NOT ATTEMPT TO CLEAR IT USING A POINTED OBJECT. Remove the pump unit from bottle.

Remove pump unit from bottle (Illustrated direction)

2. Soak only the pump unit in warm water. Squirt several times while holding under water.

Soak only the pump unit in warm water. Squirt several times while under water. (Illustrated direction)

3. Make sure the pump unit is dry. Assemble as before with 5 or 6 sprays before use.

Revised: June 2016

Bausch + Lomb, a division of
Valeant Pharmaceuticals
North America LLC
Bridgewater, NJ 08807 USA
©Bausch & Lomb Incorporated

9277302 (Folded)

9277402 (Flat)

DRUG: Flunisolide

GENERIC: Flunisolide

DOSAGE: SOLUTION

ADMINSTRATION: NASAL

NDC: 70518-0671-0

PACKAGING: 25 mL in 1 BOTTLE, PUMP

ACTIVE INGREDIENT(S):

  • FLUNISOLIDE 0.25mg in 1mL

INACTIVE INGREDIENT(S):

  • BENZALKONIUM CHLORIDE
  • PROPYLENE GLYCOL
  • POLYETHYLENE GLYCOL 3350
  • SODIUM CITRATE, UNSPECIFIED FORM
  • WATER
  • BUTYLATED HYDROXYANISOLE
  • CITRIC ACID MONOHYDRATE
  • HYDROCHLORIC ACID
  • EDETATE DISODIUM
  • SODIUM HYDROXIDE
Remedy_Label
(click image for full-size original)
FLUNISOLIDE
flunisolide solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70518-0671(NDC:24208-344)
Route of Administration NASAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FLUNISOLIDE (FLUNISOLIDE ANHYDROUS) FLUNISOLIDE 0.25 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
BENZALKONIUM CHLORIDE 0.1 mg in 1 mL
BUTYLATED HYDROXYANISOLE
CITRIC ACID MONOHYDRATE
EDETATE DISODIUM
HYDROCHLORIC ACID
POLYETHYLENE GLYCOL 3350
PROPYLENE GLYCOL
WATER
SODIUM CITRATE, UNSPECIFIED FORM
SODIUM HYDROXIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70518-0671-0 25 mL in 1 BOTTLE, PUMP None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074805 08/18/2017
Labeler — REMEDYREPACK INC. (829572556)

Revised: 05/2018 REMEDYREPACK INC.

Page 3 of 3 1 2 3

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2021. All Rights Reserved.