Potassium Citrate, Sodium Citrate, and Citric Acid (Page 2 of 2)

HOW SUPPLIED

Potassium Citrate, Sodium Citrate and Citric Acid Oral Solution (orange colored, raspberry flavored) is supplied in the following form:

NDC 69367-322-16 (16 fl oz bottles).

STORAGE

Keep tightly closed. Store at controlled room temperature, 20°-25° C (68° — 77°F). Protect from excessive heat and freezing.

Tamper evident by foil seal under cap. Do not use if foil seal is broken or missing.

Dispense in a tight, light-resistant container as defined in the USP/NF with a child-resistant closure.

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTAL OVERDOSAGE, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

Manufactured for:
Westminster Pharmaceuticals LLC.
Nashville, TN 37217
Rev. 04/21

PRINCIPAL DISPLAY PANEL — 473 mL Bottle Label

NDC: 69367-322-16
Rx Only

Potassium Citrate,
Sodium Citrate
and Citric Acid
Oral Solution

550 mg/500 mg/ 334mg per 5 mL

A SUGAR-FREE
SYSTEMIC ALKALIZER

EACH TEASPOONFUL (5 mL) CONTAINS:
POTASSIUM CITRATE MONOHYDRATE
550 mg
SODIUM CITRATE DIHYDRATE
500 mg
CITRIC ACID MONOHYDRATE
334 mg

Each mL contains 1 mEq Potassium Ion and
1 mEq Sodium Ion, and is equivalent to 2
mEq Bicarbonate (HCO₃ ).

May not meet USP monograph.

16 FL OZ (473 mL)

WestminsterPharmaceuticals

POTASSIUM CITRATE, SODIUM CITRATE, AND CITRIC ACID potassium citrate, sodium citrate, and citric acid monohydrate solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69367-322 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POTASSIUM CITRATE (ANHYDROUS CITRIC ACID) POTASSIUM CITRATE 550 mg in 5 mL SODIUM CITRATE, UNSPECIFIED FORM (ANHYDROUS CITRIC ACID) SODIUM CITRATE, UNSPECIFIED FORM 500 mg in 5 mL CITRIC ACID MONOHYDRATE (ANHYDROUS CITRIC ACID) ANHYDROUS CITRIC ACID 334 mg in 5 mL

Inactive Ingredients Ingredient Name Strength WATER SODIUM BENZOATE SACCHARIN SODIUM SORBITOL FD&C YELLOW NO. 6

Product Characteristics Color ORANGE Score Shape Size Flavor RASPBERRY Imprint Code Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:69367-322-16 473 mL in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED DRUG OTHER 07/21/2021

Labeler — Westminster Pharmaceuticals, LLC (079516651)

Revised: 01/2022 Westminster Pharmaceuticals, LLC