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).
3. Squeeze all of the medicine from the unit-dose vial into the nebulizer medicine cup (reservoir) (Figure 2).
4. Connect the nebulizer reservoir to the mouthpiece (Figure 3) or face mask (Figure 4).
5. Connect the nebulizer to the compressor (Figure 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.
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
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
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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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