Label: ORAL CITRATE SOLUTION- citric acid and sodium citrate solution
- NDC Code(s): 71321-604-16
- Packager: Brandywine Pharmaceuticals, LLC
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Drug Label Information
Updated February 19, 2024
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- SPL UNCLASSIFIED SECTION
- DESCRIPTION
- ACTION
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INDICATIONS
Oral Citrate Solution 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). Oral Citrate Solution is also effective in treatment for acidosis of certain renal tubular disorders.
- CONTRAINDICATIONS
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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
- DOSAGE AND ADMINISTRATION
- HOW SUPPLIED
- SPL UNCLASSIFIED SECTION
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PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label
NDC 71321-604-16
473 mLORAL CITRATE (SHOHL'S) SOLUTION
CONTAINS: Hydrous Sodium Citrate USP 490 mg/5 mL;
Citric Acid USP 640 mg/5 mL;grape flavor, purified water, sodium
benzoate, sodium saccharin, sorbitol
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].GTIN: 00371321604162
Rx Only
Brandywine Pharmaceuticals, LLC
West Chester, PA USA
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INGREDIENTS AND APPEARANCE
ORAL CITRATE SOLUTION
citric acid and sodium citrate solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71321-604 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL) ANHYDROUS CITRIC ACID 490 mg in 5 mL CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL) ANHYDROUS CITRIC ACID 640 mg in 5 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SORBITOL SOLUTION (UNII: 8KW3E207O2) SODIUM BENZOATE (UNII: OJ245FE5EU) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71321-604-16 473 mL in 1 BOTTLE; Type 0: Not a Combination Product 02/21/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 02/21/2024 Labeler - Brandywine Pharmaceuticals, LLC (080581956) Establishment Name Address ID/FEI Business Operations Brandywine Pharmaceuticals, LLC 080581956 label(71321-604)