Label: CALCIUM GLUCONATE injection, solution
- NDC Code(s): 57319-630-07
- Packager: Phoenix
- Category: OTC ANIMAL DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
Drug Label Information
Updated November 26, 2019
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- INDICATIONS:
- DOSAGE AND ADMINISTRATION:
- PRECAUTIONS
-
INFORMATION FOR OWNERS/CAREGIVERS
Manufactured by
Nova-Tech Inc.
Grand Island, NE 68801
RMS 92-593
18-802-50
Iss. 10-19
Lot No.
Exp. Date
NDC 57319-630-07
Calcium Gluconate 23%
Sterile - Preservative Free
Next Contents: 500 mL
PhoenixTM
Manufactured for:
Clipper Distributing Company, LLC
St. Joseph, MO 64507
Trademarks are property
of Clipper Distributing
Company, LLC
-
ACTIVE INGREDIENT
Each 500 mL CONTAINS:
Active Ingredients
Calcium Gluconate...................23% w/v
(provides 10.71 g of Calcium * per 500 mL)
Water for Injection ......................... q.s.
Inactive Ingredients
Boric Acid
(as a solubilizing agent)...........3.5 grams
Electrolytes per 1000 mL:Calcium 1069 mEq;
Hypertonic pH 2.5-4.5 - STORAGE AND HANDLING
- GENERAL PRECAUTIONS
- Caution:
- Note:
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
CALCIUM GLUCONATE
calcium gluconate injection, solutionProduct Information Product Type OTC ANIMAL DRUG Item Code (Source) NDC:57319-630 Route of Administration INTRAVENOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CALCIUM GLUCONATE (UNII: SQE6VB453K) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM GLUCONATE 23 g in 100 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:57319-630-07 500 mL in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 11/04/2019 Labeler - Phoenix (150711039) Registrant - Nova-Tech, Inc. (196078976) Establishment Name Address ID/FEI Business Operations Nova-Tech, Inc. 196078976 manufacture, api manufacture