Water: Uses, Side Effects, Dosage - Drugvu

ℹ️ Compiled from public regulatory records · Last regulator revision: May 22, 2026🚩 Report this page

Water

Active ingredient

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CA Health CanadaUS FDAGB MHRA

Drug class: -
Availability: Over-the-counter
Routes: Intravenous, Intramuscular, Subcutaneous, Intraperitoneal, Irrigation
Markets covered: 3
Products on record: 35
FDA reports (12 mo): 1,284

Overview

Water is an active pharmaceutical ingredient. The information below is compiled per regulator from the product labels on record, with direct links to the original documents.

Regulatory status by market

Market	Regulator	Products	Last revision
CA Canada	Health Canada	16	January 8, 2026
US United States	FDA	10	April 11, 2026
GB United Kingdom	MHRA	9	May 22, 2026

CACanada· Health Canada

16 products

Uses

CAOfficial regulatory label· revised March 22, 2025[1]

Sterile Water for Injection USP is indicated for use in adults and pediatric patients as a diluent or solvent in the aseptic preparation of parenteral solutions or as a vehicle for drug administration.

How to take

USUnited States· FDA

10 products

Uses

USOfficial regulatory label· revised March 29, 2017[2]

Uses washes the eye to help relieve • irritation • stinging • discomfort • itching • burning by removing • loose foreign material • air pollutants (smog or pollen) • chlorinated water

How to take

GBUnited Kingdom· MHRA

9 products

Uses

GBOfficial regulatory label· revised June 16, 2023[3]

Used for the reconstitution of freeze-dried human plasma fractions

How to take

GBOfficial regulatory label

Sources & citations

[1]Health Canada (DPD) · 01927930 · revised March 22, 2025
[2]FDA DailyMed · 049cee29-7ec2-4d… · revised March 29, 2017 [PDF]
[3]MHRA (UK) · PL106730023 · revised June 16, 2023
[4]OpenFDA adverse-event reports (US), 12 months ending June 4, 2026.

Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.

1 Dosing Considerations This solution is for intravenous use only. Do not inject until made isotonic by addition of appropriate solute. The dosage and administration of Sterile Water for Injection USP is dependent upon the recommended dosage and administration of the solute used.
Fluid administration should be based on calculated maintenance or replacement fluid requirements for each patient. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration.
Directions for Use of EXCEL® Container Warning:
Hypotonic and hemolytic. Do not inject until made isotonic by addition of appropriate solute.
Caution:
Do not use plastic containers in series connection. To Open Tear overwrap down at notch and remove solution container. Check for minute leaks by squeezing solution container firmly. If leaks are found, discard solution as sterility may be impaired.
If supplemental medication is desired, follow direction below before preparing for administration.
NOTE:
Before use, perform the following checks:  Inspect each container. Read the label. Ensure solution is the one ordered and is within the expiration date.  Invert container and carefully inspect the solution in good light for cloudiness, haze or particulate matter.
Any container which is suspect should not be used.  Use only if solution is clear and container and seals are intact.
Serious Warnings and Precautions  Hypotonic and Hemolytic:
Do not inject until made isotonic by addition of an appropriate solute; due to possibility of hemolysis (see Warnings and Precautions);  This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired (see Warnings and Precautions).
Sterile Water for Injection USP Prescribing Information Page 4 of 8 Preparation for Administration 1. Remove plastic protector from sterile set port at bottom of container. 2. Attach administration set. Refer to complete directions accompanying set.
To Add Medication Warning:
Some additives may be incompatible. Addition of medication should be accomplished using complete aseptic technique. To Add Medication Before Solution Administration 1. Prepare medication site. 2. Using syringe with 18-22 gauge needle, puncture medication port and inner diaphragm and inject.
3. Squeeze and tap ports while ports are upright and mix solution and medication thoroughly. To Add Medication During Solution Administration 1. Close clamp on the set. 2. Prepare medication site. 3. Using syringe with 18-22 gauge needle of appropriate length (at least 5/8 inch), puncture resealable medication port and inner diaphragm and inject.
4. Remove container from IV pole and/or turn to an upright position. 5. Evacuate both ports by tapping and squeezing them while container is in the upright position. 6. Mix solution and medication thoroughly. 7. Return container to in use position and continue administration.

Side effects & warnings

CAOfficial regulatory label· Adverse reactions· revised March 22, 2025[1]

Refer to the product monograph, prescribing information or package insert of the solute used. Reactions which may occur because of the solution or the technique of administration include febrile response, infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection, extravasation and hypervolemia.
The physician should also be alert to the possibility of adverse reactions to drug additives. Prescribing Information for drug additives to be administered in this manner should be consulted. If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate therapeutic countermeasures and save the remainder of the fluid for examination if deemed necessary.
Sterile Water for Injection USP Prescribing Information Page 7 of 8

CAOfficial regulatory label· Warnings and precautions· revised March 22, 2025[1]

Please see the Serious Warnings and Precautions Box at the beginning Part I:
Health Professional Information. General The administration of intravenous solutions can cause fluid and/or solute overload resulting in dilution of serum electrolyte concentrations, overhydration, congested states or pulmonary edema.
The risk of dilutional states is inversely proportional to the electrolyte concentration. To minimize the risk of possible incompatibilities arising from the mixing of additives that may be prescribed, the final infusate should be inspected for cloudiness or precipitation immediately after mixing, prior to administration and periodically during administration.
Do not use plastic container in series connection. If administration is controlled by a pumping device, care must be taken to discontinue pumping action before the container runs dry or air embolism may result. If administration is not controlled by a pumping device, refrain from applying excessive pressure (>300 mmHg) causing distortion to the container such as wringing or twisting.
Such handling could result in breakage of the container. This solution is intended for intravenous administration using sterile equipment. It is recommended that intravenous administration apparatus be replaced at least once every 24 hours.
Do not use product if liquid shows haziness, particulate matter, discolo uration, or leakage. Sterile Water for Injection USP Prescribing Information Page 6 of 8 Carcinogenesis and Mutagenesis Refer to the product monograph, prescribing information or package insert of the solute used.
Renal This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum.
Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg / kg / day accumulate aluminum at levels associated with central nervous system and bone toxicity.
Tissue loading may occur at even lower rates of administration. The drug product contains no more than 25 mcg / L of aluminum. Sexual Health Reproduction Refer to the product monograph, prescribing information or package insert of the solute used.
1 Pregnant Women Refer to the product monograph, prescribing information or package insert of the solute used. 2 Breast-feeding Refer to the product monograph, prescribing information or package insert of the solute used. 3 Pediatrics See WARNINGS AND PRECAUTIONS, Renal.
Refer to the product monograph, prescribing information or package insert of the solute used. 4 Geriatrics See WARNINGS AND PRECAUTIONS, Renal. Refer to the product monograph, prescribing information or package insert of the solute used.

This is not medical advice. Consult a qualified healthcare professional.