FDA Label for Formoterol Fumarate
View Indications, Usage & Precautions
Formoterol Fumarate Product Label
The following document was submitted to the FDA by the labeler of this product Aucta Pharmaceuticals, Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
How Supplied
Formoterol Fumarate Inhalation Solution, 20 mcg/2 mL is supplied as clear, colorless sterile solution for nebulization in 2.5 mL low-density polyethylene unit dose vials. Each vial is overwrapped in a foil pouch and supplied in cartons as listed below.
Carton of 30 individually wrapped unit dose vials, NDC 73289-0060-1
Carton of 60 individually wrapped unit dose vials, NDC 73289-0060-2
Storage and Handling:
Prior to dispensing to the patient: Store in a refrigerator, 2°C to 8°C (36°F to 46°F). Protect pouch from light and heat.
After dispensing to the patient: Store in a refrigerator at 2°C to 8°C (36°F to 46°F) and discard when drug expires or store at room temperature, 20°C to 25°C (68°F to 77°F) and discard if not used after 3 months. Protect pouch from light and heat.
• Formoterol Fumarate Inhalation Solution should only be administered via a standard jet nebulizer connected to an air compressor with an adequate airflow and equipped with a facemask or mouthpiece.•Vial should always be stored in the foil pouch, and only removed IMMEDIATELY before use.•Do not take by mouth.•Contents of any partially used container should be discarded.•Discard the container and top after use.•Keep out of the reach of children
Package Label.Principal Display Panel
Foil Label
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