FDA.reportPublic FDA data

Calcium Gluconate

Manufacturer
Henry Schein | Nova-Tech, Inc.
Effective date
2019-02-28
Label type
OTC ANIMAL DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-02 00:30:19

Label at a glance#

ProductCalcium Gluconate
Active ingredientCALCIUM GLUCONATE
Label structure8 sections

Dosage and administration

Cattle: 250 to 500 mL Administer intravenously or intraperitoneally. Solution should be warmed to body temperature and administered slowly. This product is sterile in unopened container. It contains no preservative. Use entire contents when first opened. It should be handled under strict aseptic conditions. If there is no apparent improvement in the animal's condition within 24 hours, consult a veterinarian.

Storage and handling

Store at controlled room temperature 15 degrees - 30 degrees C (59 degrees - 86 degrees F).

Label contents#

Full prescribing information#

COMPOSITION:

OTC - ACTIVE INGREDIENT SECTION

Each 500 mL of sterile aqueous solution contains:
Calcium.............................. 10.7 g
  (as calcium borogluconate, equivalent to calcium gluconate, 23%)
MILLIEQUIVALENTS PER LITER

Cations
  Calcium...................................... 1069 mEq/L
Anions
  Gluconate................................... 1069 mEq/L

INDICATIONS:

INDICATIONS & USAGE SECTION

For use as an aid in the treatment of hypocalcemia (parturient paresis, milk fever) in cattle.

DOSAGE AND ADMINISTRATION:

DOSAGE & ADMINISTRATION SECTION

Cattle: 250 to 500 mL
Administer intravenously or intraperitoneally. Solution should be
warmed to body temperature and administered slowly. This product is
sterile in unopened container. It contains no preservative. Use entire
contents when first opened. It should be handled under strict aseptic
conditions. If there is no apparent improvement in the animal's
condition within 24 hours, consult a veterinarian.

STORAGE AND HANDLING SECTION

Store at controlled room temperature 15 degrees - 30 degrees C (59 degrees - 86 degrees F).

WARNINGS AND PRECAUTIONS SECTION

TAKE TIME OBSERVE LABEL DIRECTIONS

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

FOR ANIMAL USE ONLY
KEEP OUT OF REACH OF CHILDREN

INFORMATION FOR OWNERS/CAREGIVERS SECTION

NDC: 11695-6404-5

Calcium Borogluconate Solution

500 mL

Questions? (855) 724-3461

Reorder #002453

AH-002453-01

Manufactured by
Nova-Tech, Inc.
Grand Island, NE 68801

Distributed by:
Henry Schein Animal Health
Dublin, OH 43017
www.henryscheinvet.com

18-802
RMS# 92-536
Rev: 0418

Lot No.

Exp. Date

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

500 ml label500 ml label

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CALCIUM GLUCONATEACTIVE INGREDIENTSQE6VB453K1
CALCIUM CATIONACTIVE MOIETY2M83C4R6ZB1

Products#

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

DailyMed product names page 1 of 1 · 2 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11695-640411695-6404-5

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
CALCIUM GLUCONATESQE6VB453KACTIB

Source Document#

Source XML

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 2 · 21 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
brand name: calcium gluconate
generic name: CALCIUM GLUCONATE
calcium gluconateCALCIUM GLUCONATEAmneal Pharmaceuticals Private Limited787603c6-3f50-473a-8e3b-71dcf6d869642026-06-23Warnings, Adverse reactionsName fallback
brand name: calcium gluconate
generic name: CALCIUM GLUCONATE
Calcium GluconateCALCIUM GLUCONATEGLENMARK PHARMACEUTICALS INC., USAb2470072-f443-4596-ae33-1b8b0d05bc9d2026-06-11Warnings, Adverse reactionsName fallback
brand name: Calcium Gluconate
generic name: CALCIUM GLUCONATE
Calcium GluconateCALCIUM GLUCONATEFresenius Kabi USA, LLC8b77c3d2-992d-4261-8421-9cfd07328fbf2026-05-18Warnings, Adverse reactionsName fallback
brand name: Calcium Gluconate
generic name: CALCIUM GLUCONATE
Calcium GluconateCALCIUM GLUCONATECaplin Steriles Limitedf28e9871-d546-4b48-ac3d-aead0d4c04492026-05-13Warnings, Adverse reactionsName fallback
brand name: Calcium Gluconate
generic name: CALCIUM GLUCONATE
calcium gluconateCALCIUM GLUCONATEAmneal Pharmaceuticals Private Limited13d7cfc9-ff7a-437e-8c21-d9709ac07d482026-05-12Warnings, Adverse reactionsName fallback
brand name: calcium gluconate
generic name: CALCIUM GLUCONATE
Calcium GluconateCALCIUM GLUCONATEHenry Schein, Inc.3cbf6bf7-2415-4435-b3df-41855514a05d2025-12-23Warnings, Adverse reactionsName fallback
brand name: Calcium Gluconate
generic name: CALCIUM GLUCONATE
Calcium GluconateCALCIUM GLUCONATEHenry Schein, Inc.841ea51f-dc0d-45ed-8b55-bb64640cb9302025-11-03Warnings, Adverse reactionsName fallback
brand name: Calcium Gluconate
generic name: CALCIUM GLUCONATE
Calcium GluconateCALCIUM GLUCONATEREMEDYREPACK INC.4c635f60-7868-46d5-b932-d5cf8fc844322025-09-29Warnings, Adverse reactionsName fallback
brand name: Calcium Gluconate
generic name: CALCIUM GLUCONATE
Calcium GluconateCALCIUM GLUCONATEProPharma Distribution38413366-b558-7dd0-e063-6394a90acb7e2025-07-18Warnings, Adverse reactionsName fallback
brand name: Calcium Gluconate
generic name: CALCIUM GLUCONATE
CALCIUM GLUCONATECALCIUM GLUCONATESomerset Therapeutics, LLCfb40eba7-04e5-40dc-8a95-5f45e7bd70bc2025-02-06Warnings, Adverse reactionsName fallback
brand name: CALCIUM GLUCONATE
generic name: CALCIUM GLUCONATE
Calcium GluconateCALCIUM GLUCONATEFresenius Kabi USA, LLC1aaf5c76-e526-4d8b-887e-cc3c4f39cc8b2024-08-21Warnings, Adverse reactionsName fallback
brand name: Calcium Gluconate
generic name: CALCIUM GLUCONATE
Calcium GluconateCALCIUM GLUCONATEFresenius Kabi USA, LLC7f5101e0-abf9-4fcf-8986-c799e33334342024-05-06Warnings, Adverse reactionsName fallback
brand name: Calcium Gluconate
generic name: CALCIUM GLUCONATE
CALCIUM GLUCONATECALCIUM GLUCONATEAmneal Pharmaceuticals Private Limited8ee79b4c-21d3-4742-ae37-e2f5629177062024-04-18Warnings, Adverse reactionsName fallback
brand name: CALCIUM GLUCONATE
generic name: CALCIUM GLUCONATE
CALCIUM GLUCONATECALCIUM GLUCONATEHF Acquisition Co LLC, DBA HealthFirst788ab6d7-d80c-0220-e053-2991aa0ae6e92024-02-01Warnings, Adverse reactionsName fallback
brand name: CALCIUM GLUCONATE
generic name: CALCIUM GLUCONATE
calcium gluconateCALCIUM GLUCONATEHikma Pharmaceuticals USA Inc.8ec4d137-1e9b-40e2-aeb2-8f62626a8fa52023-09-01Warnings, Adverse reactionsName fallback
brand name: calcium gluconate
generic name: CALCIUM GLUCONATE
calcium gluconateCALCIUM GLUCONATEHikma Pharmaceuticals USA Inc.ce7becd8-cf59-4470-aac8-82761a24ebd72023-09-01Warnings, Adverse reactionsName fallback
brand name: calcium gluconate
generic name: CALCIUM GLUCONATE
calcium gluconateCALCIUM GLUCONATEHikma Pharmaceuticals USA Inc.313a4ea9-178b-495e-9bc7-af1860fa65012023-05-26Warnings, Adverse reactionsName fallback
brand name: calcium gluconate
generic name: CALCIUM GLUCONATE
Calcium GluconateCALCIUM GLUCONATEMedical Purchasing Solutions, LLCb6226367-b061-eec5-e053-2a95a90a617d2023-05-04Warnings, Adverse reactionsName fallback
brand name: Calcium Gluconate
generic name: CALCIUM GLUCONATE
Calcium GluconateCALCIUM GLUCONATEB. Braun Medical Inc.af362bcb-7010-4eb5-b8c4-42aa3b0cdcde2023-04-28Warnings, Adverse reactionsName fallback
brand name: Calcium Gluconate
generic name: CALCIUM GLUCONATE

Reported adverse events (FAERS/openFDA)#

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