{"effective_time":"20241203","health_care_provider_letter":["HEALTH CARE PROFESSIONAL LETTER Please refer to the FDA approved package insert for the full prescribing information of the drug product as follows: • Lactated Ringer’s Injection, USP (click https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=dad7735c-709b-40ea-ab7a-15577e24a966 ) 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 (1-800-332-0178). To report product quality issues associated with these imported products, please contact Baxter Product Surveillance through Baxter - Product Feedback Portal ( https://productfeedback.baxter.com/ ). DHCP Letter 1.jpg DHCP Letter 2.jpg DHCP Letter 3.jpg DHCP Letter 4.jpg DHCP Letter 5.jpg DHCP Letter 6.jpg"],"id":"811f979a-004c-4c62-8f57-7bcaa29c7da5","openfda":{},"package_label_principal_display_panel":["PACKAGE/LABEL PRINCIPAL DISPLAY PANEL Baxter Logo Trademark A6E2323 SODIUM LACTATE RINGER’S INJECTION 100 200 300 400 500ml [Strength] 500ml Each 500ml contains 1.55g Sodium Lactate, 3.00g Sodium Chloride, 0.15g Potassium Chloride, and 0.10g Calcium Chloride Dihydrate [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: H19983144 [Drug Marketing Authorization Holder] [Manufacturer] Name: Baxter Healthcare (Shanghai) Co., Ltd. Address: No. 388, Tingzhu Road, Jinshan District, Shanghai LOT MFG EXP Lactated Ringer Representative Carton Label 500ml Chinese.jpg"],"set_id":"b4993d9d-6b1a-496a-b5f8-8904a8420b8c","spl_product_data_elements":["Lactated Ringers Sodium chloride, potassium chloride, sodium lactate and calcium chloride SODIUM CHLORIDE SODIUM CATION CHLORIDE ION SODIUM LACTATE SODIUM CATION LACTIC ACID, UNSPECIFIED FORM POTASSIUM CHLORIDE POTASSIUM CATION CHLORIDE ION CALCIUM CHLORIDE CHLORIDE ION WATER"],"version":"2"}