Patient information: uses, side effects, how to take - Dextrose Monohydrate
INSTRUCTIONS FOR USE:
Check flexible container solution composition, lot number, and expiry date.
Do not remove solution container from its overwrap until immediately before use.
Use sterile equipment and aseptic technique.
To Open
- 1. Turn solution container over so that the text is face down. Using the pre-cut corner tabs, peel open the overwrap and remove solution container.
- 2. Check the solution container for leaks by squeezing firmly. If leaks are found, or if the seal is not intact, discard the solution.
- 3. Do not use if the solution is cloudy or a precipitate is present.
To Add Medication
The Additive port of the free flex ® + container accepts standard luer lock syringes. Do not use a needle for additions.
- 1. Identify LIGHT BLUE Additive Port with arrow pointing toward solution container.
- 2. Immediately before injecting additives, break off LIGHT BLUE Additive Port Cap with the arrow pointing toward solution container.
- 3. Hold base of LIGHT BLUE Additive Port.
- 4. Attach Luer Lock syringe to the threaded LIGHT BLUE Additive Port. Inject additive.
- 5. Mix solution container contents thoroughly.
Preparation for Administration
- 1. Immediately before inserting the infusion set, break off BLUE Infusion Port Cap with the arrow pointing away from container.
- 2. Use a non-vented infusion set or close the air-inlet on a vented set.
- 3. Close the roller clamp of the infusion set.
- 4. Hold the base of BLUE Infusion Port.
- 5. Insert spike through BLUE Infusion Port by rotating wrist slightly until the spike is inserted.
NOTE: See full directions accompanying administration set.
WARNING: Do not use flexible container in series connections.
About this document
Source: FDA drug labeling via NLM DailyMed · Application number: ANDA 207449
· View the label on DailyMed
Revision date stated in the text: August 2024
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The information on this site does not replace the advice of a doctor or pharmacist.
Drug information for Dextrose Monohydrate
| Rx or OTC |
Prescription (Rx)?
- This drug is available only with a prescription from a licensed healthcare provider.
- Rx
|
| Active ingredient |
Dextrose monohydrate
|
| Dosage form |
Injection, solution |
| Route |
Intravenous |
| Marketing status |
listed in the FDA NDC Directory |
| Company (applicant) |
FRESENIUS KABI USA |
| FDA approval |
ANDA 207449Abbreviated New Drug Application (ANDA) – generic drug
Approved October 21, 2016
|
| Therapeutic equivalence (TE) code |
APCodes starting with A mean the FDA rates the drug therapeutically equivalent to its reference drug (Orange Book). |
| Manufacturers |
11 labelers list this drug on DailyMed |
| Drug shortage |
-
Current since November 3, 2026
|
| Recalls |
-
April 2, 2026: Class II recall: Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
-
March 11, 2026: Class II recall: Lack of Assurance of Sterility
-
March 11, 2026: Class II recall: Lack of Assurance of Sterility
Show more recalls (1)+
-
March 11, 2026: Class II recall: Lack of Assurance of Sterility
|
| Packages (NDC) |
| Package |
|
2500 mg/50 mL – 50 ml in 1 bag / 60 in 1 case
NDC 65219-234-01
|
|
5000 mg/100 mL – 100 ml in 1 bag / 50 in 1 case
NDC 65219-236-01
|
|
12500 mg/250 mL – 250 ml in 1 bag / 30 in 1 case
NDC 65219-238-01
|
|
25000 mg/500 mL – 500 ml in 1 bag / 20 in 1 case
NDC 65219-240-01
|
|
Source: FDA drug labeling via NLM DailyMed, data as of November 5, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.