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

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 June 27, 2016

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Rx Only

    Close
  • DESCRIPTION

    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
  • ACTION

    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
  • INDICATIONS

    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
  • 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.

    Close
  • 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.

    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).

    PHARMACIST

    Dispense in well-closed containers.

    Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F). [See USP Controlled Room Temperature].

    Close
  • SPL UNCLASSIFIED SECTION

    CMP Pharma, Inc.
    Post Office Box 147
    Farmville, North Carolina 27828

    Revised July 2015

    Copyright © CMP Pharma, Inc. 2015

    Close
  • PRINCIPAL DISPLAY PANEL - 500 mL Bottle Label

    NDC 46287-014-01
    500 mL

    Oracit®
    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
    Temperature].

    Rx Only

    LOT:
    EXP:

    CMP
    PHARMA
    Farmville, NC 27828

    PRINCIPAL DISPLAY PANEL - 500 mL Bottle Label
    Close
  • INGREDIENTS AND APPEARANCE
    ORACIT 
    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)
    Close