Label: CALCIUM GLUCONATE- calcium gluconate injection
- NDC Code(s): 61133-0297-7
- Packager: Bimeda, Inc., Division of Cross Vetpharm Group
- Category: OTC ANIMAL DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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- INDICATIONS & USAGE
INDICATIONS: To be used as an aid in the treatment of parturient paresis (milk fever) in cattle.Close
- DOSAGE & ADMINISTRATION
DOSAGE AND ADMINISTRATION:
Cattle: 250 mL 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. Discard any unused portion. Handle under aseptic conditions.
If there is no apparent improvement in the animal's condition within 24 hours, consult a veterinarian.
EACH 100 mL CONTAINS:
(provides 2.14 grams Calcium)..........................23 grams
Water for Injection...................................................q.s.
Contains boric acid as a solubilizing agent.
ELECTROLYTES PER 1000 mL:
Calcium 1069 mEq
Osmolarity (calc.) 6,947 m0smol/L
- STORAGE AND HANDLING
STORAGE: Store between 15⁰C - 30⁰C (59⁰F - 86⁰F).Close
- INGREDIENTS AND APPEARANCE
calcium gluconate injection
Product Information Product Type OTC ANIMAL DRUG Item Code (Source) NDC:61133-0297 Route of Administration INTRAPERITONEAL, INTRAVENOUS DEA Schedule 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:61133-0297-7 500 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 03/23/2005 Labeler - Bimeda, Inc., Division of Cross Vetpharm Group (060492923) Registrant - Bimeda, Inc. Division of Cross Vetpharm Group (060492923) Establishment Name Address ID/FEI Business Operations Bimeda-MTC., Division of Cross Vetpharm Group 256232216 manufacture Establishment Name Address ID/FEI Business Operations Zhejiang Ruibang 544807456 api manufacture