Oracit

Dosage form: liquid
Ingredients: CITRIC ACID MONOHYDRATE 490mg in 5mL, TRISODIUM CITRATE DIHYDRATE 640mg in 5mL
Labeler: Cardinal Health
NDC Code: 55154-7352

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.

Oracit 15 ml Bottles

Active ingredient

This product is a clear, colorless solution containing Citric Acid USP 640 mg/5 mL, and Hydrous Sodium Citrate USP 490 mg/5 mL.

Purpose

Oral citrate solution is used as a systemic and urinary alkalinizer. Less than 5% of the citrate is excreted in urine unchanged, since citrate oxidation is to a great extent complete.

Uses

ORACIT® is indicated for the treatment of metabolic acidosis. This solution is also useful in conditions where long term maintenance of alkaline urine is needed (e.g. uric acid and cystine calculi of the urinary tract). ORACIT® is also effective in treatment for acidosis of certain renal tubular disorders.

Contraindications

ORACIT® is contraindicated in patients with severe renal impairment, oliguria or azotemia, untreated Addison's disease, adynamia episodica hereditaria, acute dehydration, heat cramp, anuria, severe myocardial damage, and hyperkalemia.

Warning

Precautions

The citrate solution should be used with caution in patients with impaired renal function to avoid hypernatremia or alkalosis in the presence of hypocalcemia. Periodic determinations of serum electrolyte levels (especially bicarbonate levels) should be done in patients with renal disease to avoid cardiac failure, hypertension, peripheral and pulmonary edema, and toxemia of pregnancy. The solution should be diluted with water and preferably taken after meals to avoid saline laxative effects.

Adverse Reactions

Citrate solution is generally well tolerated when given in recommended dosed when the patient has normal renal functions.

Directions

Dosage and Administration

The dose of ORACIT® is 10 to 30 mL, diluted with water, after meals and at bedtime. The dose should be titrated to achieve desired effects.

Inactive ingredients

It also contain Methylparaben NF and Propylparaben NF as preservatives. These concentrations yield 1 mEq of sodium, equivalent to 1 mEq of bicarbonate per mL of solution.

How Supplied

ORACIT® is supplied in 500 mL bottles (NDC 46287-014-01), 30 mL unit dose bottles, 10 bottles per carton (NDC 46287-014-30), and 15 mL unit dose bottles, 10 bottles per carton (NDC 46287-014-15).

Storage

Dispense in well-closed containers. Store at Controlled Room Temperature (15-30 C).

Carolina Medical Products Co.

Post Office Box 147

Farmville, North Carolina 27828

Revised May 1986

Copyright© Carolina Medical Products Co. 1985

Keep Out Of The Reach Of Children

Keep this and all drugs out of the reach of children.

Principal Display Panel

Oracit®

Oral Citrate (SHOHL'S) Solution

5 x 15 mL Bottles

ORACIT 
oral citrate liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55154-7352(NDC:46287-014)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CITRIC ACID MONOHYDRATE (ANHYDROUS CITRIC ACID) ANHYDROUS CITRIC ACID490 mg  in 5 mL
TRISODIUM CITRATE DIHYDRATE (ANHYDROUS CITRIC ACID) ANHYDROUS CITRIC ACID640 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
METHYLPARABEN 
PROPYLPARABEN 
ALCOHOL 
Packaging
#Item CodePackage Description
1NDC:55154-7352-55 BOTTLE in 1 BAG
115 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other06/07/2011
Labeler - Cardinal Health (188557102)
Establishment
NameAddressID/FEIOperations
Cardinal Health188557102REPACK(55154-7352)

Revised: 04/2013
 
Cardinal Health

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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