Label: ORACIT- citric acid and sodium citrate solution
- NDC Code(s): 46287-014-01, 46287-014-15, 46287-014-30
- Packager: CMP Pharma, Inc.
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Updated June 27, 2016
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- SPL UNCLASSIFIED SECTION
The product is a clear, colorless solution containing Citric Acid USP 640 mg/5 mL, and Hydrous Sodium Citrate USP 490 mg/5 mL. It also contains Methylparaben NF and Propylparaben NF as preservatives. These concentrations yield 1 mEq of sodium, equivalent to 1 mEq of bicarbonate per mL of solution.Close
Oral citrate solution is used as a systemic and urinary alkalinizer. Less than 5% of the citrate is excreted in the urine unchanged, since citrate oxidation is to a great extent complete.Close
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.Close
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.Close
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.Close
- ADVERSE REACTIONS
Citrate solution is generally well tolerated when given in recommended doses when the patient has normal renal functions.Close
- 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.Close
- 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).
Dispense in well-closed containers.
- SPL UNCLASSIFIED SECTION
CMP Pharma, Inc.
Post Office Box 147
Farmville, North Carolina 27828
Revised July 2015
Copyright © CMP Pharma, Inc. 2015Close
- PRINCIPAL DISPLAY PANEL - 500 mL Bottle Label
ORAL CITRATE (SHOHL'S) SOLUTION
CONTAINS: Hydrous Sodium Citrate USP 490 mg/5 mL;
Citric Acid USP 640 mg/5 mL; Methylparaben NF;
Propylparaben NF; Alcohol USP 0.25%.
USUAL DOSAGE: See package insert.
Dispense in a well-closed container.
Store at 20°-25°C (68°-77°F); excursions permitted
to 15°-30°C (59°-86°F). [See USP Controlled Room
Farmville, NC 27828
- INGREDIENTS AND APPEARANCE
citric acid and sodium citrate solution
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:46287-014 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL) ANHYDROUS CITRIC ACID 640 mg in 5 mL TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL) ANHYDROUS CITRIC ACID 490 mg in 5 mL Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:46287-014-01 500 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/15/1984 2 NDC:46287-014-30 10 in 1 CARTON 05/15/1984 2 30 mL in 1 BOTTLE, UNIT-DOSE; Type 0: Not a Combination Product 3 NDC:46287-014-15 10 in 1 CARTON 05/15/1984 3 15 mL in 1 BOTTLE, UNIT-DOSE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Unapproved drug other 05/15/1984 Labeler - CMP Pharma, Inc. (005224175) Establishment Name Address ID/FEI Business Operations CMP Pharma, Inc. 005224175 MANUFACTURE(46287-014)