FDA Label for Glucose And Sodium Chloride
View Indications, Usage & Precautions
Glucose And Sodium Chloride Product Label
The following document was submitted to the FDA by the labeler of this product Baxter Healthcare Corporation. 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.
Health Care Professional Letter
Reporting Adverse Events or Product Quality Issues
To report adverse events associated with these imported products, please call Baxter at 1-866-888-2472, or fax: 1- 800-759-1801. Adverse events or quality problems experienced with the use of these imported products may also be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax:
• Complete and submit the report Online: www.fda.gov/medwatch/report.htm
• Regular mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.
To report product quality issues associated with these imported products, please contact Baxter Product Surveillance through Baxter - Product Feedback Portal (https://productfeedback.baxter.com/).
Please also refer to the local prescribing information of the imported product, translated into English, available for:
• 0.9% Sodium Chloride Injection (click https://nctr-crs.fda.gov/fdalabel/ui/spl-summaries/criteria/723233)
• 5% Glucose Injection (click https://nctr-crs.fda.gov/fdalabel/ui/spl-summaries/criteria/723235)
• 10% Glucose Injection (click https://nctr-crs.fda.gov/fdalabel/ui/spl-summaries/criteria/723237)
• 5% Glucose/0.9% Sodium Chloride Injection (click https://nctr-crs.fda.gov/fdalabel/ui/spl-summaries/criteria/723238)
Please refer to the FDA-approved prescribing information for each drug product listed below:
• 0.9% Sodium Chloride Injection USP (click https://www.dailymed.nlm.nih.gov/dailymed/getFile.cfm?setid=f55bd888-5e01-474d-871b-24654c070178&type=pdf&name=f55bd888-5e01-474d-871b-24654c070178)
• 5% Dextrose Injection USP (click https://www.dailymed.nlm.nih.gov/dailymed/getFile.cfm?setid=3bb406a9-f5cb-403a-b1bb-5c4facbea3d5&type=pdf&name=3bb406a9-f5cb-403a-b1bb-5c4facbea3d5)
• 10% Dextrose Injection USP (click https://www.dailymed.nlm.nih.gov/dailymed/getFile.cfm?setid=3bb406a9-f5cb-403a-b1bb-5c4facbea3d5&type=pdf&name=3bb406a9-f5cb-403a-b1bb-5c4facbea3d5)
• 5% Dextrose/0.9% Sodium Chloride Injection USP (click https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/016678s007,016683s103,016687s104,016689s107,016697s098lbl.pdf)
Package/Label Principal Display Panel
Baxter Logo Trademark
A6C1064US
GLUCOSE AND
SODIUM CHLORIDE INJECTION
100
200
300
400
500
600
700
800
900
1000ml
5% GLUCOSE
0.9% SODIUM CHLORIDE
[Strength] 1000ml: glucose 50g
and sodium chloride 9g
[Description] This product is a clear, colorless liquid
[Dosage and Administration] Intravenous drip See the
package insert for details
For details of [Indications], [Adverse Reactions],
[Contraindications], and [Precautions], please refer to the
package insert
[Storage] Store in overwrap
The solution should be clear and should be used
up at one time
Inspect the inner bag by squeezing it and discard
solution if leakage occurs
License Number: H19994068
AA
[Drug Marketing Authorization Holder] [Manufacturer]
Name: Baxter Healthcare (Shanghai) Co., Ltd.
Address: No. 388, Tingzhu Road, Jinshan District, Shanghai
BarCode
(01) 00303389799016
LOT
MFG
EXP
5% Glucose/0.9% Sodium Chloride Injection
1000ml X 12
LOT S0000000 EXP YYYY-MM
A6C1064US 1C/N LIC H19994068
5% Glucose/0.9% Sodium Chloride Injection
1000ml X 12
LOT S0000000 EXP YYYY-MM
MFG YYYY-MM-DD 1C/N 0000
* Please review the disclaimer below.
