IRON ASPARTATE GLYCINATE AND POLYSACCHARIDE COMPLEX, ASCORBIC CALCIUM, VITAMIN B12, FOLIC ACID, CALCIUM THREONATE AND SUCCINIC ACID- calcium ascorbate, calcium threonate, folic acid, cyanocobalamin, ferrous asparto glycinate, iron dextran and succinic acid capsule 
Virtus Pharmaceuticals LLC

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Iron Aspartate Glycinate and Polysaccharide Complex/Ascorbic Calcium/Vitamin B12/ Folic Acid/Calcium Threonate/Succinic Acid (150 mg-60 mg-25 mcg-1 mg-0.8 mg-50 mg) Capsules

STATEMENT OF IDENTITY: Iron Aspartate Glycinate and Polysaccharide Complex/Ascorbic Calcium/Vitamin B12/Folic Acid/Calcium Threonate/Succinic Acid (150 mg-60 mg-25 mcg-1 mg-0.8 mg-50 mg) is an orally administered prescription dietary supplement specifically formulated for the dietary management of patients with unique nutritional needs for iron deficiencies and/or nutritional megaloblastic anemias.

WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6 years of age. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately. Caution is recommended in patients with a history of bipolar illness.

DOSAGE AND ADMINISTRATION: The usual adult dose is 1 capsule daily with or without food or as directed by a licensed medical practitioner.

Vitamin C
Ascorbic Acid (as Calcium Ascorbate)
60 mg
Threonic Acid (as Calcium Threonate)0.8 mg
Folic Acid 1 mg
Vitamin B12 (as Cyanocobalamin) 25 mcg
Elemental Iron
(as ferrous aspartate, glycinate)
50 mg
(as Polysaccharide Complex)100 mg
Succinic Acid 50 mg

Other ingredients: Microcrystalline Cellulose, Silicon Dioxide, Magnesium Stearate, Gelatin, Titanium Dioxide, FD&C Red # 40 and other ancillary ingredients as needed to ensure product stability.

How Supplied: Iron Aspartate Glycinate and Polysaccharide Complex/Ascorbic Calcium/Vitamin B12/Folic Acid/Calcium Threonate/Succinic Acid (150 mg-60 mg-25 mcg-1 mg-0.8 mg-50 mg) capsules are red/white capsules, debossed with "V212", and are supplied in bottles of 90 capsules.

PRECAUTIONS/WARNING: PREGNANCY and NURSING MOTHERS: Iron Aspartate Glycinate and Polysaccharide Complex/Ascorbic Calcium/Vitamin B12/Folic Acid/Calcium Threonate/Succinic Acid (150 mg-60 mg-25 mcg-1 mg-0.8 mg-50 mg) is not intended for use as a prenatal/postnatal multivitamin for lactating and non-lactating mothers. This product contains a B vitamin in reduced form. Talk with your medical practitioner before using if pregnant or lactating.

STORAGE: Store at controlled room temperature 15°-30°C (59°-86°F). [See USP]. Protect from light and moisture. Dispense in a tight, light-resistant container.

HEALTH CLAIMS: Prescription Vitamin B and Iron Containing Dietary Supplement

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

VIRTUS
PHARMACEUTICALS

NDC 76439-212-90

Iron Aspartate Glycinate and
Polysaccharide Complex/
Ascorbic Calcium/Vitamin B12/
Folic Acid/Calcium Threonate/
Succinic Acid

(150 mg-60 mg-25 mcg-1 mg-0.8 mg-50 mg)

Prescription Dietary Supplement

Rx

90 Tablets      Made in USA

PRINCIPAL DISPLAY PANEL - 90 capsules
IRON ASPARTATE GLYCINATE AND POLYSACCHARIDE COMPLEX, ASCORBIC CALCIUM, VITAMIN B12, FOLIC ACID, CALCIUM THREONATE AND SUCCINIC ACID 
calcium ascorbate, calcium threonate, folic acid, cyanocobalamin, ferrous asparto glycinate, iron dextran and succinic acid capsule
Product Information
Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:76439-212
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALCIUM ASCORBATE (UNII: 183E4W213W) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID60 mg
CALCIUM L-THREONATE (UNII: HBB4YPO93U) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM L-THREONATE0.8 mg
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID1 mg
CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN25 ug
FERROUS ASPARTO GLYCINATE (UNII: H7426RGB3L) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION50 mg
IRON DEXTRAN (UNII: 95HR524N2M) (FERRIC CATION - UNII:91O4LML611) FERRIC CATION100 mg
SUCCINIC ACID (UNII: AB6MNQ6J6L) (SUCCINIC ACID - UNII:AB6MNQ6J6L) SUCCINIC ACID50 mg
Inactive Ingredients
Ingredient NameStrength
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NHRIC:76439-212-9090 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
DIETARY SUPPLEMENT07/29/201308/22/2014
Supplement Facts
Serving Size : Serving per Container :
Amount Per Serving% Daily Value
color
color
scoring1
shape
size (solid drugs)19 mm
imprint
Labeler - Virtus Pharmaceuticals LLC (969483143)

Revised: 11/2017
 
Virtus Pharmaceuticals LLC