FDA.reportPublic FDA data

Sykes Calcium Gluconate 23% Solution

Manufacturer
Sypharma Pty Ltd
Effective date
2017-12-19
Label type
OTC ANIMAL DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 01:06:19

Label at a glance#

ProductSykes Calcium Gluconate 23%
Active ingredientCALCIUM GLUCONATE
Label structure10 sections

Dosage and administration

FOR INTRAVENOUS ADMINISTRATION ONLY. CATTLE 250 – 500 mL DOSAGE MAY BE REPEATED AT 8 TO 12 HOUR INTERVALS IF REQUIRED.

Storage and handling

STORE BETWEEN 59°F-86°F/15°C-30°C IN BARRIER OVER-POUCH UNTIL READY FOR USE. PROTECT FROM FREEZING.

Label contents#

Full prescribing information#

GENERAL PRECAUTIONS SECTION

STERILE NONPYROGENIC SOLUTION
For Animal Use Only

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN

INFORMATION FOR OWNERS/CAREGIVERS SECTION

500 mL

Each 100mL contains:

DOSAGE FORMS & STRENGTHS SECTION

CALCIUM GLUCONATE (PROVIDES 2.14 grams OF CALCIUM) 23 grams
WATER FOR INJECTION q.s.
BORIC ACID (AS A SOLUBILIZING AGENT) 3.5 grams

mEq/L CALCIUM 1069, HYPERTONIC, pH: 2.5 to 4.5, OSMOLARITY: 6,782 mOsmol/L (calc)

INDICATIONS

INDICATIONS & USAGE SECTION

FOR USE IN CATTLE AS AN AID IN TREATING UNCOMPLICATED MILK FEVER (PARTURIENT PARESIS).

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

FOR INTRAVENOUS ADMINISTRATION ONLY.
CATTLE 250 – 500 mL
DOSAGE MAY BE REPEATED AT 8 TO 12 HOUR INTERVALS IF REQUIRED.

CAUTION

PRECAUTIONS SECTION

SOLUTION SHOULD BE WARMED TO BODY TEMPERATURE AND ADMINISTERED SLOWLY. ENTIRE CONTENTS SHOULD BE USED UPON ENTERING, AS THIS PRODUCT CONTAINS NO PRESERVATIVE. DISCARD ANY UNUSED PORTION. DO NOT USE IF SOLUTION IS CLOUDY OR CONTAINS PRECIPITATE. MONITOR ANIMAL’S CONDITION CLOSELY. RE-TREATMENT MAY BE NECESSARY. IF THERE IS NO NOTICEABLE IMPROVEMENT WITHIN 24 HOURS FOLLOWING TREATMENT, CONSULT YOUR VETERINARIAN. ASEPTIC PRECAUTIONS SHOULD BE OBSERVED.

STORAGE

STORAGE AND HANDLING SECTION

STORE BETWEEN 59°F-86°F/15°C-30°C IN BARRIER OVER-POUCH UNTIL READY FOR USE. PROTECT FROM FREEZING.

INFORMATION FOR OWNERS/CAREGIVERS SECTION

Made in Australia

MANUFACTURED AND DISTRIBUTED BY: SYPHARMA PTY LTD, 27 HEALEY ROAD, DANDENONG VICTORIA 3175 AUSTRALIA.

FOR CUSTOMER SERVICE EMAIL: CUSTOMERSERVICE@SYPHARMA.COM.AU

NDC NUMBER: 86043-1004-2    BARCODE: 9317643192506

BATCH NUMBER:

EXPIRY:

500mL Sykes Calcium Gluconate 23% Solution

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CalciumGluconate23CalciumGluconate23CalciumGluconate23CalciumGluconate23

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-139317643192506GTIN-13: 9317643192506
EAN-13: 9317643192506
GTIN storage (14 digits): 09317643192506		CalciumGluconate23.jpg

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
86043-1004SYKES CALCIUM GLUCONATE 23% (CALCIUM GLUCONATE) SOLUTION [SYPHARMA PTY LTD]2Unmatched20171219_115f2bc6-b3f5-41a3-b2f9-e69f4d620637.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
86043-100486043-1004-2

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
CALCIUM GLUCONATESQE6VB453KACTIB
WATER059QF0KO0RIACT

Source Document#

Source XML · Source PDF

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 20 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
calcium gluconateCALCIUM GLUCONATEREMEDYREPACK INC.d6db3a1c-ed02-48fc-9134-ea1d58acf42e2026-09-08Warnings, Adverse reactionsName fallback
generic name: CALCIUM GLUCONATE
calcium gluconateCALCIUM GLUCONATEAmneal Pharmaceuticals Private Limited787603c6-3f50-473a-8e3b-71dcf6d869642026-06-23Warnings, Adverse reactionsName fallback
generic name: CALCIUM GLUCONATE
Calcium GluconateCALCIUM GLUCONATEGLENMARK PHARMACEUTICALS INC., USAb2470072-f443-4596-ae33-1b8b0d05bc9d2026-06-11Warnings, Adverse reactionsName fallback
generic name: CALCIUM GLUCONATE
Calcium GluconateCALCIUM GLUCONATEFresenius Kabi USA, LLC8b77c3d2-992d-4261-8421-9cfd07328fbf2026-05-18Warnings, Adverse reactionsName fallback
generic name: CALCIUM GLUCONATE
Calcium GluconateCALCIUM GLUCONATECaplin Steriles Limitedf28e9871-d546-4b48-ac3d-aead0d4c04492026-05-13Warnings, Adverse reactionsName fallback
generic name: CALCIUM GLUCONATE
calcium gluconateCALCIUM GLUCONATEAmneal Pharmaceuticals Private Limited13d7cfc9-ff7a-437e-8c21-d9709ac07d482026-05-12Warnings, Adverse reactionsName fallback
generic name: CALCIUM GLUCONATE
Calcium GluconateCALCIUM GLUCONATEHenry Schein, Inc.841ea51f-dc0d-45ed-8b55-bb64640cb9302025-11-03Warnings, Adverse reactionsName fallback
generic name: CALCIUM GLUCONATE
Calcium GluconateCALCIUM GLUCONATEREMEDYREPACK INC.4c635f60-7868-46d5-b932-d5cf8fc844322025-09-29Warnings, Adverse reactionsName fallback
generic name: CALCIUM GLUCONATE
Calcium GluconateCALCIUM GLUCONATEProPharma Distribution38413366-b558-7dd0-e063-6394a90acb7e2025-07-18Warnings, Adverse reactionsName fallback
generic name: CALCIUM GLUCONATE
CALCIUM GLUCONATECALCIUM GLUCONATESomerset Therapeutics, LLCfb40eba7-04e5-40dc-8a95-5f45e7bd70bc2025-02-06Warnings, Adverse reactionsName fallback
generic name: CALCIUM GLUCONATE
Calcium GluconateCALCIUM GLUCONATEFresenius Kabi USA, LLC1aaf5c76-e526-4d8b-887e-cc3c4f39cc8b2024-08-21Warnings, Adverse reactionsName fallback
generic name: CALCIUM GLUCONATE
Calcium GluconateCALCIUM GLUCONATEFresenius Kabi USA, LLC7f5101e0-abf9-4fcf-8986-c799e33334342024-05-06Warnings, Adverse reactionsName fallback
generic name: CALCIUM GLUCONATE
CALCIUM GLUCONATECALCIUM GLUCONATEAmneal Pharmaceuticals Private Limited8ee79b4c-21d3-4742-ae37-e2f5629177062024-04-18Warnings, Adverse reactionsName fallback
generic name: CALCIUM GLUCONATE
CALCIUM GLUCONATECALCIUM GLUCONATEHF Acquisition Co LLC, DBA HealthFirst788ab6d7-d80c-0220-e053-2991aa0ae6e92024-02-01Warnings, Adverse reactionsName fallback
generic name: CALCIUM GLUCONATE
calcium gluconateCALCIUM GLUCONATEHikma Pharmaceuticals USA Inc.8ec4d137-1e9b-40e2-aeb2-8f62626a8fa52023-09-01Warnings, Adverse reactionsName fallback
generic name: CALCIUM GLUCONATE
calcium gluconateCALCIUM GLUCONATEHikma Pharmaceuticals USA Inc.ce7becd8-cf59-4470-aac8-82761a24ebd72023-09-01Warnings, Adverse reactionsName fallback
generic name: CALCIUM GLUCONATE
calcium gluconateCALCIUM GLUCONATEHikma Pharmaceuticals USA Inc.313a4ea9-178b-495e-9bc7-af1860fa65012023-05-26Warnings, Adverse reactionsName fallback
generic name: CALCIUM GLUCONATE
Calcium GluconateCALCIUM GLUCONATEMedical Purchasing Solutions, LLCb6226367-b061-eec5-e053-2a95a90a617d2023-05-04Warnings, Adverse reactionsName fallback
generic name: CALCIUM GLUCONATE
Calcium GluconateCALCIUM GLUCONATEB. Braun Medical Inc.af362bcb-7010-4eb5-b8c4-42aa3b0cdcde2023-04-28Warnings, Adverse reactionsName fallback
generic name: CALCIUM GLUCONATE
CALCIUM GLUCONATECALCIUM GLUCONATEHF Acquisition Co LLC, DBA HealthFirst7d93251a-b555-0be0-e053-2991aa0ad7642022-12-10Warnings, Adverse reactionsName fallback
generic name: CALCIUM GLUCONATE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.