VIRTRATE-2- trisodium citrate dihydrate and citric acid monohydrate liquid 
Virtus Pharmaceuticals

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Virtrate-2

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-2 is an orally administered prescription systemic alkalinizing dietary supplement1 and should be administered under the supervision of a licensed medical practitioner.

Virtrate-2 is an effective alkalinizing agent due to sodium citrate, which when absorbed is metabolized to sodium bicarbonate. It is useful in those conditions in which long-term maintenance of alkaline urine is desirable, such as people with renal insufficiency or the syndrome of renal tubular acidosis, especially when the administration of potassium salts is undesirable or contraindicated. Virtrate-2 also is useful for buffering and neutralizing gastric acidity quickly and effectively.

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 Sodium Ion and is equivalent to 1 mEq Bicarbonate (HCO3).
†
Daily Value not established
Sodium Citrate Dihydrate500 mg *††
Citric Acid Monohydrate334 mg *††

Other Ingredients: Propylene Glycol, Sorbitol, Polyethylene Glycol 400, Sodium Benzoate, Sodium Saccharin, Natural Grape Flavor and Purified Water.

DOSAGE AND ADMINISTRATION

Virtrate-2 is concentrated, and when consumed after meals and before bedtime, allows one to maintain an alkaline urinary pH around the clock. When consumed as recommended, Virtrate-2 alkalinizes the urine without producing a systemic alkalosis. This product is highly palatable and pleasant tasting even when consumed over long periods.

Virtrate-2 should be taken diluted in water, followed by additional water, if desired. SHAKE WELL BEFORE USING.

For Systemic Alkalization

Usual Adult Dose

2 to 6 teaspoonfuls (10 to 30 mL), diluted in 1 to 3 ounces of water, after meals and at bedtime, or as directed by a physician.

Usual Pediatric Dose

1 to 3 teaspoonfuls (5 to 15 mL), diluted in 1 to 3 ounces of water, after meals and at bedtime, or as directed by a physician. For children under two years of age, use is based on consultation with a physician.

As a neutralizing buffer

3 teaspoonfuls (15 mL), diluted with 15 mL water, taken as a single dose, or as directed by a physician.

CONTRAINDICATIONS

Virtrate-2 is contraindicated for people on sodium-restricted diets or with severe renal impairment.

PRECAUTIONS

Virtrate-2 should be used with caution by people with low urinary output unless they are under the supervision of a physician. It should not be administered concurrently with aluminum-based antacids. Virtrate-2 should be diluted adequately with water. If possible, take each dose after meals to avoid saline laxative effect. People with cardiac failure, hypertension, impaired renal function, peripheral and pulmonary edema, and toxemia of pregnancy should use sodium salts cautiously. Persons with renal disease should have periodic determinations of serum electrolytes, particularly serum bicarbonate, in order to avoid complications.

ADVERSE REACTIONS

When consumed as recommended by people with normal renal function and urinary output, Virtrate-2 generally has no unpleasant side effects. Persons with abnormal renal mechanisms should be careful to avoid development of alkalosis, especially in the presence of hypocalcemia.

OVERDOSAGE

Overdosage with sodium salts may cause diarrhea, nausea and vomiting, hypernoia, and convulsions.

KEEP THIS AND ALL MEDICATIONS OUT OF REACH OF CHILDREN

HOW SUPPLIED

Virtrate-2 is supplied as colorless, grape 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 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

76439-367-16

VIRTRATE-2

Sodium Citrate-Citric Acid USP

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-2 
trisodium citrate dihydrate and citric acid monohydrate liquid
Product Information
Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:76439-367
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
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)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NHRIC:76439-367-16473 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
flavor
Labeler - Virtus Pharmaceuticals (969483143)

Revised: 10/2017
Document Id: 79091af0-bfb1-494b-8503-472fa4aa36e1
Set id: ba19ddf3-3623-4a9d-8651-24d8879692d6
Version: 2
Effective Time: 20171013
 
Virtus Pharmaceuticals