Label: ORACIT- citric acid monohydrate and trisodium citrate dihydrate liquid
- NDC Code(s): 55154-7352-5
- Packager: Cardinal Health
- This is a repackaged label.
- Source NDC Code(s): 46287-014
- 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.
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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.Close
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.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.
Citrate solution is generally well tolerated when given in recommended dosed 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
- 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.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).Close
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. 1985Close
- Keep Out Of The Reach Of Children
Keep this and all drugs out of the reach of children.Close
- Principal Display Panel
Oral Citrate (SHOHL'S) Solution
5 x 15 mL Bottles
- INGREDIENTS AND APPEARANCE
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)