VIRTRATE-3- potassium citrate, trisodium citrate dihydrate, and citric acid monohydrate liquid 
Virtus Pharmaceuticals

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Virtrate-3

Prescription Systemic Alkalinizing Dietary Supplement1


1
This statement has not been evaluated by the Food and Drug Administration (FDA). This product is not intended to diagnose, treat, cure or prevent any disease.

Rx

DESCRIPTION

Virtrate-3 is an orally administered prescription systemic alkalinizing dietary supplement1 and should be administered under the supervision of a licensed medical practitioner.

Potassium citrate and sodium citrate are absorbed and metabolized to potassium bicarbonate and sodium bicarbonate, thus acting as systemic alkalinizing agents.

Supplement Facts
Serving Size: 1 Teaspoon (5 mL)
Amount Per Serving% Daily Value for Children Under 4 Years of Age% Daily Value for Adults and Children 4 or More Years of Age
*
Each mL contains 1 mEq Potassium Ion and 1 mEq Sodium Ion, and is equivalent to 2 mEq Bicarbonate (HCO3).
Daily Value not established
Potassium Citrate Monohydrate550 mg *
Sodium Citrate Dihydrate500 mg *
Citric Acid Monohydrate334 mg *

Other Ingredients: Propylene Glycol, Sorbitol, Polyethylene Glycol 400, Sodium Benzoate, Sodium Saccharin, FD&C Yellow #6, Natural Raspberry Flavor and Purified Water.

Contains FD&C Yellow #6

DOSAGE AND ADMINISTRATION

Virtrate-3 is highly concentrated, and when consumed after meals and before bedtime, allows one to maintain an alkaline urine pH around the clock. When consumed as recommended, this product alkalinizes the urine without producing a systemic alkalosis. It is highly palatable and pleasant tasting. Potassium citrate and sodium citrate do not neutralize the gastric juice or disturb digestion.

Virtrate-3 should be taken diluted in water, followed by additional water, if desired. Palatability is enhanced if chilled before taking.

Usual Adult Dose

3 to 6 teaspoonfuls (15 to 30 mL), diluted in water, four times a day, after meals and at bedtime, or as directed by a physician.

Usual Pediatric Dose

1 to 3 teaspoonfuls (5 to 15 mL), diluted in water, four times a day, after meals and at bedtime, or as directed by a physician.

Usual Dosage Range

2 to 3 teaspoonfuls (10 to 15 mL), diluted with water, taken four times a day, will usually maintain a urinary pH of 6.5-7.4. 3 to 4 teaspoonfuls (15 to 20 mL), diluted with water, taken four times a day, will usually maintain a urinary pH of 7.0-7.6 throughout most of the 24 hours without unpleasant side effects. To check urine pH, HYDRION Paper (pH 6.0-8.0) or NITRAZINE Paper (pH 4.5-7.5) are available and easy to use.

CONTRAINDICATIONS

Virtrate-3 is contraindicated in people with severe renal impairment with oliguria or azotemia, untreated Addison's disease, or severe myocardial damage. In certain situations, when people are on a sodium-restricted diet, the use of potassium citrate may be preferable; or, when people are on a potassium-restricted diet, the use of sodium citrate may be preferable.

PRECAUTIONS

Virtrate-3 should be used with caution by persons with low urinary output or reduced glomerular filtration rates unless they are under the supervision of a physician. Aluminum-based antacids should be avoided in these patients. Virtrate-3 should be diluted adequately with water and, preferably, taken after meals, to minimize the possibility of gastrointestinal injury associated with oral ingestion of potassium salt preparations and to avoid saline laxative effect. Persons with cardiac failure, hypertension, peripheral and pulmonary edema, and toxemia of pregnancy should use sodium salts cautiously.

Concurrent administration of potassium-containing supplements, potassium-sparing diuretics, angiotensin- converting enzyme (ACE) inhibitors, or cardiac glycosides may lead to toxicity. Persons with renal disease should have periodic determinations of serum electrolytes, particularly serum bicarbonate, in order to avoid these complications.

ADVERSE REACTIONS

When consumes as recommended by people with normal renal function and urinary output, Virtrate-3 generally is well tolerated and has no unpleasant side effects. However certain patients with abnormal renal mechanisms should be careful to avoid development of hyperkalemia or alkalosis, especially in the presence of hypocalcemia. Potassium intoxication causes listlessness, weakness, mental confusion, and tingling of extremities.

OVERDOSAGE

Overdosage with sodium salts may cause diarrhea, nausea and vomiting, hypernoia, and convulsions. Overdosage with potassium salts may cause hyperkalemia and alkalosis, especially in the presence of renal disease.

KEEP THIS AND ALL MEDICATIONS OUT OF REACH OF CHILDREN

HOW SUPPLIED

Virtrate-3 is supplied as orange colored, raspberry flavored liquid dispensed in 16 fl. oz. (472 mL) bottles.

STORAGE

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

Rx

Manufactured for:
Virtus Pharmaceuticals, LLC
Tampa, FL 33619
1-888-848-3593

Rev. 03/15

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

VIRTUS
PHARMACEUTICALS

76439-366-16

VIRTRATE-3

Potassium Citrate-Sodium
Citrate-Citric Acid

Prescription Systemic Alkalinizing
Dietary Supplement*

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

Rx
16 fl. oz. (473mL)

Sugar-Free
Made in the USA

Principal Display Panel - 473 mL Bottle Label
VIRTRATE-3 
potassium citrate, trisodium citrate dihydrate, and citric acid monohydrate liquid
Product Information
Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:76439-366
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POTASSIUM CITRATE (UNII: EE90ONI6FF) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL) POTASSIUM CITRATE550 mg  in 5 mL
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL) ANHYDROUS CITRIC ACID500 mg  in 5 mL
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL) ANHYDROUS CITRIC ACID334 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SORBITOL (UNII: 506T60A25R)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NHRIC:76439-366-16472 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
DIETARY SUPPLEMENT05/15/201505/30/2017
Supplement Facts
Serving Size : Serving per Container :
Amount Per Serving% Daily Value
color
flavor
Labeler - Virtus Pharmaceuticals (969483143)

Revised: 10/2017
 
Virtus Pharmaceuticals