ARFORMOTEROL TARTRATE (Page 8 of 8)

Instructions for Using Arformoterol Tartrate [AR-for-MOE-ter-ol TAR-trate] 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).
ifu-figure-1
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Figure 1

1.
Squeeze all of the medicine from the unit-dose vial into the nebulizer medicine cup (reservoir) (Figure 2).
ifu-figure-2
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Figure 2

1.
Connect the nebulizer reservoir to the mouthpiece (Figure 3) or face mask (Figure 4).
ifu-figure-3-4
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1.
Connect the nebulizer to the compressor (Figure 5).
ifu-figure-5
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Figure 5

1.
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.
ifu-figure-6
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Figure 6

1.
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.
2.
Clean the nebulizer (see manufacturer’s instructions).

Rx Only

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

Manufactured by:

Glenmark Pharmaceuticals Inc., USA

Monroe, NC 28110

Manufactured for:

logo

Glenmark Pharmaceuticals Inc., USA

Mahwah, NJ 07430

Questions? 1 (888) 721-7115

www.glenmarkpharma-us.com

December 2020

Package/Label Display Panel

NDC 68462-833-85

Arformoterol Tartrate Inhalation Solution

15 mcg*/2mL

*Potency expressed as arformoterol.

For Inhalation Only.

One Unit-Dose Vial is One Dose.

Pouch Label

pouch1-2mL
(click image for full-size original)

Package/Label Display Panel

NDC 68462-833-65

Arformoterol Tartrate Inhalation Solution

15 mcg*/2mL


*Potency expressed as arformoterol.

For Inhalation Only.

60 x 2mL Sterile Unit-Dose Vials

Carton Label

carton-60
(click image for full-size original)
ARFORMOTEROL TARTRATE
arformoterol tartrate solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68462-833
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
ANHYDROUS CITRIC ACID
TRISODIUM CITRATE DIHYDRATE
SODIUM CHLORIDE
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68462-833-30 30 POUCH in 1 CARTON contains a POUCH
1 1 VIAL in 1 POUCH This package is contained within the CARTON (68462-833-30) and contains a VIAL
1 2 mL in 1 VIAL This package is contained within a POUCH and a CARTON (68462-833-30)
2 NDC:68462-833-60 15 POUCH in 1 CARTON contains a POUCH
2 4 VIAL in 1 POUCH This package is contained within the CARTON (68462-833-60) and contains a VIAL
2 2 mL in 1 VIAL This package is contained within a POUCH and a CARTON (68462-833-60)
3 NDC:68462-833-65 12 POUCH in 1 CARTON contains a POUCH
3 5 VIAL in 1 POUCH This package is contained within the CARTON (68462-833-65) and contains a VIAL
3 2 mL in 1 VIAL This package is contained within a POUCH and a CARTON (68462-833-65)
4 NDC:68462-833-35 6 POUCH in 1 CARTON contains a POUCH
4 5 VIAL in 1 POUCH This package is contained within the CARTON (68462-833-35) and contains a VIAL
4 2 mL in 1 VIAL This package is contained within a POUCH and a CARTON (68462-833-35)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA213132 06/22/2021 05/01/2023
Labeler — GLENMARK PHARMACEUTICALS INC., USA (130597813)
Establishment
Name Address ID/FEI Operations
GLENMARK PHARMACEUTICALS INC., USA 079922908 MANUFACTURE (68462-833), ANALYSIS (68462-833)

Revised: 12/2020 GLENMARK PHARMACEUTICALS INC., USA

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