Formoterol Fumarate (Page 7 of 7)

INSTRUCTIONS FOR USE

Formoterol Fumarate (for moe’ ter ol fue’ ma rate)

Inhalation Solution

Using Formoterol Fumarate Inhalation Solution

Formoterol fumarate inhalation solution is used only in a standard jet nebulizer machine connected to an air compressor. Make sure you know how to use your nebulizer machine before you use it to breathe in formoterol fumarate inhalation solution or other medicines.

Do not mix formoterol fumarate inhalation solution with other medicines in your nebulizer machine.

Formoterol fumarate inhalation solution comes sealed in a foil pouch. Do not open a sealed pouch until you are ready to use a dose of formoterol fumarate inhalation solution.

  1. Remove vial from the foil pouch.
  2. Twist the cap completely off the vial and squeeze all the medicine into the nebulizer medicine cup (reservoir) (Figure 1).
    1
    (click image for full-size original)

  3. Connect the nebulizer reservoir to the mouthpiece or facemask (Figure 2).
    1
    (click image for full-size original)

  4. Connect the nebulizer to the compressor.
  5. Sit in a comfortable, upright position. Place the mouthpiece in your mouth (Figure 3) or put on the facemask (Figure 4); and turn on the compressor.
    11
  6. Breathe as calmly, deeply and evenly as possible through your mouth until no more mist is formed in the nebulizer reservoir. The average nebulization time is 9 minutes. At this point, the treatment is finished.
  7. Discard the formoterol fumarate inhalation solution container and top after use.
  8. Clean the nebulizer (see manufacturer’s instructions).

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

Manufactured In England By:
Norton Healthcare Limited
T/A IVAX Pharmaceuticals UK
Runcorn, Cheshire WA7 3FA England

Manufactured For:
Teva Pharmaceuticals USA, Inc.
Parsippany, NJ 07054

Iss. 10/2020

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0093-4061-30

Formoterol Fumarate
Inhalation Solution
20 mcg/2 mL vial

Sterile Unit Dose Vials — Individually Wrapped — For Oral Inhalation Only.
Each 2 mL Vial Contains: ACTIVE: Formoterol fumarate, USPINACTIVES: Citric acid, sodium citrate, sodium chloride, and water.

PHARMACIST: DISPENSE THE ENCLOSED PATIENT INFORMATION TO EACH PATIENT.

Rx only

30 individually wrapped

2 mL vials

1
(click image for full-size original)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0093-4061-06

Formoterol Fumarate
Inhalation Solution
20 mcg/2 mL vial

Sterile Unit Dose Vials — Individually Wrapped — For Oral Inhalation Only.
Each 2 mL Vial Contains: ACTIVE: Formoterol fumarate, USPINACTIVES: Citric acid, sodium citrate, sodium chloride, and water.

PHARMACIST: DISPENSE THE ENCLOSED PATIENT INFORMATION TO EACH PATIENT.

Rx only

60 individually wrapped

2 mL vials

1
(click image for full-size original)
FORMOTEROL FUMARATE formoterol fumarate solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0093-4061
Route of Administration RESPIRATORY (INHALATION) DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FORMOTEROL FUMARATE (FORMOTEROL) FORMOTEROL FUMARATE 20 ug in 2 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE
WATER
CITRIC ACID MONOHYDRATE
SODIUM CITRATE, UNSPECIFIED FORM
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0093-4061-30 30 POUCH in 1 CARTON contains a POUCH (0093-4061-19)
1 NDC:0093-4061-19 1 VIAL in 1 POUCH This package is contained within the CARTON (0093-4061-30) and contains a VIAL
1 2 mL in 1 VIAL This package is contained within a POUCH (0093-4061-19) and a CARTON (0093-4061-30)
2 NDC:0093-4061-06 60 POUCH in 1 CARTON contains a POUCH
2 1 VIAL in 1 POUCH This package is contained within the CARTON (0093-4061-06) and contains a VIAL
2 2 mL in 1 VIAL This package is contained within a POUCH and a CARTON (0093-4061-06)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091141 06/22/2021
Labeler — Teva Pharmaceuticals USA, Inc. (001627975)

Revised: 10/2020 Teva Pharmaceuticals USA, Inc.

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