FDA Label for Glycopyrrolate
View Indications, Usage & Precautions
Glycopyrrolate 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 70771-1616-1
Glycopyrrolate Injection, USP
0.2 mg/mL
NOT FOR USE IN NEWBORNS
CONTAINS BENZYL ALCOHOL
FOR INTRAMUSCULAR OR
INTRAVENOUS ADMINISTRATION
1 mL Single-Dose Vial
Rx only
NDC 70771-1616-7
Glycopyrrolate Injection, USP
0.2 mg/mL
NOT FOR USE IN NEWBORNS
CONTAINS BENZYL ALCOHOL
FOR INTRAMUSCULAR OR INTRAVENOUS ADMINISTRATION
25 x 1 mL Single-Dose Vials
Rx only
NDC 70771-1617-1
Glycopyrrolate Injection, USP
0.4 mg/2 mL
(0.2 mg/mL)
NOT FOR USE IN NEWBORNS
CONTAINS BENZYL ALCOHOL
FOR INTRAMUSCULAR OR
INTRAVENOUS ADMINISTRATION
2 mL Single-Dose Vial
Rx only
NDC 70771-1617-7
Glycopyrrolate Injection, USP
0.4 mg/2 mL
(0.2 mg/mL)
NOT FOR USE IN NEWBORNS
CONTAINS BENZYL ALCOHOL
FOR INTRAMUSCULAR OR INTRAVENOUS ADMINISTRATION
25 x 2 mL Single-Dose Vials
Rx only
NDC 70771-1618-1
Glycopyrrolate Injection, USP
1 mg/5 mL
(0.2 mg/mL)
NOT FOR USE IN NEWBORNS
CONTAINS BENZYL ALCOHOL
FOR INTRAMUSCULAR OR
INTRAVENOUS ADMINISTRATION
5 mL Multiple-Dose Vial
Rx only
NDC 70771-1618-7
Glycopyrrolate Injection, USP
1 mg/5 mL
(0.2 mg/mL)
NOT FOR USE IN NEWBORNS
CONTAINS BENZYL ALCOHOL
FOR INTRAMUSCULAR OR INTRAVENOUS ADMINISTRATION
25 x 5 mL Multiple-Dose Vials
Rx only
NDC 70771-1619-1
Glycopyrrolate Injection, USP
4 mg/20 mL
(0.2 mg/mL)
NOT FOR USE IN NEWBORNS
CONTAINS BENZYL ALCOHOL
FOR INTRAMUSCULAR OR
INTRAVENOUS ADMINISTRATION
20 mL Multiple-Dose Vial
Rx only
NDC 70771-1619-6
Glycopyrrolate Injection, USP
4 mg/20 mL
(0.2 mg/mL)
NOT FOR USE IN NEWBORNS
CONTAINS BENZYL ALCOHOL
FOR INTRAMUSCULAR OR INTRAVENOUS ADMINISTRATION
10 x 20 mL Multiple-Dose Vials
Rx only
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