FDA Label for Fulvestrant
View Indications, Usage & Precautions
Fulvestrant Product Label
The following document was submitted to the FDA by the labeler of this product Zydus Lifesciences Limited. 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.
Package Label.Principal Display Panel
NDC 70771-1626-2
Fulvestrant Injection
250 mg/5 mL (50 mg/mL)
For Intramuscular Use Only
Both single-dose prefilled syringes must be administered to receive the 500 mg dose.
PROTECT FROM LIGHT
Rx only
Made in India
NDC 70771-1626-8
Fulvestrant Injection
250 mg/5 mL (50 mg/mL)
For Intramuscular Use Only
This carton contains a total of 500 mg fulvestrant in TWO single-dose prefilled syringes each containing 250 mg/5 mL, and two Safety Glide™ shielding intramuscular injection needles.
Discard each syringe after use.
Both single-dose prefilled syringes must be administered to receive the 500 mg dose.
STORAGE: REFRIGERATE 2° to 8°C (36° to 46°F). TO PROTECT FROM LIGHT, STORE IN THE ORIGINAL CARTON UNTIL TIME OF USE.
Contains 2 Single-Dose Prefilled Syringes
Rx only
* Please review the disclaimer below.