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

PRINCIPAL DISPLAY PANEL -- 473 mL Bottle Label
(click image for full-size original)
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

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