Label: ORACIT- citric acid monohydrate and trisodium citrate dihydrate liquid 

  • Category: HUMAN OTC 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.

Drug Label Information

Updated 04/13

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  • 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.

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  • 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.

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  • 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.

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  • 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.

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  • 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.

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  • 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.

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  • 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.

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  • 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).

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  • 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

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  • Keep Out Of The Reach Of Children

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

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  • Principal Display Panel

    Oracit®

    Oral Citrate (SHOHL'S) Solution

    5 x 15 mL Bottles

    bag label
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  • INGREDIENTS AND APPEARANCE
    ORACIT 
    oral citrate liquid
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:55154-7352(NDC:46287-014)
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CITRIC ACID MONOHYDRATE (ANHYDROUS CITRIC ACID) ANHYDROUS CITRIC ACID 490 mg  in 5 mL
    TRISODIUM CITRATE DIHYDRATE (ANHYDROUS CITRIC ACID) ANHYDROUS CITRIC ACID 640 mg  in 5 mL
    Inactive Ingredients
    Ingredient Name Strength
    METHYLPARABEN  
    PROPYLPARABEN  
    ALCOHOL  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:55154-7352-5 5 in 1 BAG
    1 15 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    Unapproved drug other 06/07/2011
    Labeler - Cardinal Health (188557102)
    Establishment
    Name Address ID/FEI Business Operations
    Cardinal Health 188557102 REPACK(55154-7352)
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