WATER injection

Drug Labeling and Warnings

Drug Details [pdf]

WARNINGS

HEMOLYTIC and HYPOTONIC. Additives may be incompatible. Consultation with a pharmacist is recommended. When introducing additives, use aseptic technique, mix thoroughly and do not store. Not for Intravenous unless rendered nearly Isotonic. For usual dosage see insert. Sterile, nonpyrogenic. Use only if solution is clear and container is undamaged. Must not be used in a series connections.

HEALTH CARE PROVIDER LETTER

Purpose:

This product is being distributed in response to a shortage of Sterile Water For Injection, USP product in the United States as per U.S. Food and Drug; FDA Drug Shortgae List.

Regulatory Status:

This product has not been approved by the U.S. Food and Drug Administration but is being made available under enforcement discretion during a drug shortage.

Product Descritpion:

This product only have Water for Injection, USP.

Dosing and Administration:

The route of administration is intravenous. Product is not for direct intravenous use unless rendered nearly Isotonic. It can be used as a drug diluent. Following suitable admixture of prescribed additive, the final product dose is usually dependent upon the age, weight and clinical condition of the patient.

Safety Information:

Additives may be incompatible. Please confirm compatibility.

Storage and Handling:

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

Reporting Adverse Events:

Report adverse events to wwww.fda.gov/medwatch or 1-800-FDA-1088.

Contact Information:

For any question or concern, please contact 1-863-292-2211. Email: Info@AssureIV.com.

Package Label

INGREDIENTS AND APPEARANCE

WATER 
water injection

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 83155-103
Route of Administration	INTRAVENOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R)	WATER	250 mL  in 250 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83155-103-50	500 mL in 1 CONTAINER; Type 0: Not a Combination Product	04/16/2026
2	NDC: 83155-103-25	250 mL in 1 CONTAINER; Type 0: Not a Combination Product	04/16/2026
3	NDC: 83155-103-10	1000 mL in 1 CONTAINER; Type 0: Not a Combination Product	04/16/2026

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved drug for use in drug shortage		04/16/2026

Labeler - Assure Infusions, Inc. (053016941)

Registrant - Assure Infusions, Inc. (053016941)

Establishment
Name	Address	ID/FEI	Business Operations
Assure Infusions, Inc.		053016941	manufacture(83155-103)