Arformoterol Tartrate (Page 8 of 8)

INSTRUCTIONS FOR USE

Instructions for Using Arformoterol Tartrate Inhalation Solution

Arformoterol tartrate 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 arformoterol tartrate inhalation solution or other medicines.

Do not mix arformoterol tartrate inhalation solution with other medicines in your nebulizer machine.

Arformoterol tartrate inhalation solution comes sealed in a foil pouch. Do not open a sealed pouch until you are ready to use a dose of arformoterol tartrate inhalation solution. After opening the pouch, unused unit-dose vials should be returned to, and stored in, the pouch. An opened unit-dose vial should be used right away.

1. Open the foil pouch by tearing on the rough edge along the seam of the pouch. Remove a unit-dose vial of arformoterol tartrate inhalation solution.
2. Carefully twist open the top of the unit-dose vial and use it right away ( Figure 1).
spl-arformoterol-ifu-fig-1

3. Squeeze all of the medicine from the unit-dose vial into the nebulizer medicine cup (reservoir) (Figure 2).
spl-arformoterol-ifu-fig-2

4. Connect the nebulizer reservoir to the mouthpiece (Figure 3) or face mask (Figure 4).

spl-arformoterol-ifu-fig-3-4
(click image for full-size original)

5. Connect the nebulizer to the compressor (Figure 5).
spl-arformoterol-ifu-fig-5

6. Sit in a comfortable, upright position. Place the mouthpiece in your mouth (Figure 6) (or put on the face mask) and turn on the compressor.

spl-arformoterol-ifu-fig-6
(click image for full-size original)

7. Breathe as calmly, deeply, and evenly as possible until no more mist is formed in the nebulizer reservoir. It takes about 5 to 10 minutes for each treatment.
8. Clean the nebulizer (see manufacturer’s instructions).

Rx Only

This Instructions for Use has been approved by the Food and Drug Administration.
Dispense with Patient Information available at: https://www.sunpharma.com/usa/products

Manufactured by:

Sun Pharmaceutical Medicare Limited

Baska Ujeti Road, Ujeti

Halol-389350, Gujarat, India.

Distributed by:

Sun Pharmaceutical Industries, Inc.

Cranbury, NJ 08512

ISS. 05/2022

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL — Pouch Label

NDC 62756-277-01
Arformoterol Tartrate Inhalation Solution
15 mcg*/2 mL
*Potency expressed as arformoterol
For Oral Inhalation Only
After opening the foil pouch, the unused vials should be returned to, and stored in, the pouch. One unit-dose vial is one dose.
Keep out of reach of children
Rx only
5 x 2 mL Sterile Unit-Dose Vials
Start Room Temp. Storage………………………………….
Use by:……………………………………………………………. SUN PHARMA

spl-arformoterol-label
(click image for full-size original)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL — Carton Label

NDC 62756-277-02
Arformoterol Tartrate Inhalation Solution
15 mcg*/2 mL
*Potency expressed as arformoterol
For Oral Inhalation Only
KEEP REFRIGERATED OR STORE AT ROOM TEMPERATURE FOR UP TO 6 WEEKS
Rx only
30 x 2 mL Sterile Unit-Dose Vials
(6 pouches of five 2 mL vials each)
SUN PHARMA

spl-arformoterol-carton
(click image for full-size original)
ARFORMOTEROL TARTRATE arformoterol tartrate solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62756-277
Route of Administration RESPIRATORY (INHALATION) DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ARFORMOTEROL TARTRATE (ARFORMOTEROL) ARFORMOTEROL 15 ug in 2 mL
Inactive Ingredients
Ingredient Name Strength
CITRIC ACID MONOHYDRATE
TRISODIUM CITRATE DIHYDRATE
SODIUM CHLORIDE
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62756-277-02 6 POUCH in 1 CARTON contains a POUCH
1 5 VIAL, SINGLE-DOSE in 1 POUCH This package is contained within the CARTON (62756-277-02) and contains a VIAL, SINGLE-DOSE
1 2 mL in 1 VIAL, SINGLE-DOSE This package is contained within a POUCH and a CARTON (62756-277-02)
2 NDC:62756-277-03 12 POUCH in 1 CARTON contains a POUCH
2 5 VIAL, SINGLE-DOSE in 1 POUCH This package is contained within the CARTON (62756-277-03) and contains a VIAL, SINGLE-DOSE
2 2 mL in 1 VIAL, SINGLE-DOSE This package is contained within a POUCH and a CARTON (62756-277-03)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA215385 05/28/2022
Labeler — Sun Pharmaceutical Industries, Inc. (146974886)
Establishment
Name Address ID/FEI Operations
Sun Pharmaceutical Medicare Limited 725420835 ANALYSIS (62756-277), MANUFACTURE (62756-277)

Revised: 05/2022 Sun Pharmaceutical Industries, Inc.

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