NEOSTIGMINE METHYLSULFATE- neostigmine methylsulfate injection, solution
Cantrell Drug Company

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Neostigmine Methylsulfate 1:1,000 Injection Solution 5 mL Syringe

• WARNINGS AND PRECAUTIONS

Outsourced Compounded Drug. Not for Resale. Hospital/Office Use Only.

• ADVERSE EVENTS

To facilitate Adverse Event Reporting: www.fda.gov/medwatch or 1-800-FDA-1088.

• HOW SUPPLIED

Neostigmine Methylsulfate is supplied as a sterile, nonpyrogenic solution that is clear, colorless in a 5 mL Single Use Syringe.

This product is Preservative-Free and Latex-Free.

• INGREDIENTS

Each 1 mL contains 1 mg neostigmine methylsulfate in Water for Injection q.s. The aqueous solution is adjusted to a pH of 5.0- 6.5 with acetic acid and/or sodium hydroxide, if necessary.

• STORAGE AND HANDLING

Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]. Protect from light.

• DOSAGE AND ADMINISTRATION.

FOR SLOW INTRAVENOUS USE ONLY. PRESERVATIVE-FREE INJECTION SOLUTION.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Rx Only

Rev. 02/15

CANTRELL DRUG COMPANY

LITTLE ROCK, AR 72207

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NEOSTIGMINE METHYLSULFATE
neostigmine methylsulfate injection, solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:52533-046
Route of Administration	INTRAVENOUS

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
NEOSTIGMINE METHYLSULFATE (UNII: 98IMH7M386) (NEOSTIGMINE - UNII:3982TWQ96G)	NEOSTIGMINE METHYLSULFATE	1 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:52533-046-15	5 mL in 1 SYRINGE, PLASTIC; Type 0: Not a Combination Product	02/03/2015	12/06/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		02/03/2015	12/06/2017

Labeler - Cantrell Drug Company (035545763)

Revised: 12/2017

Document Id: 5fae791e-af67-3bdc-e053-2a91aa0ae801

Set id: 86963fc9-468c-4842-a76a-c5c1f5510c75

Version: 2

Effective Time: 20171206

Cantrell Drug Company