FERROUS FUMARATE- ferrous fumarate tablet 
Virtus Pharmaceuticals LLC

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Ferrous Fumarate 324 mg

STATEMENT OF IDENTITY: Ferrous Fumarate 324 mg is an orally administered iron supplement and should be administered under the supervision of a licensed medical practitioner.

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

DOSAGE AND ADMINISTRATION: 1 tablet daily, in between meals, orally. Do not exceed recommended dosage. Do not administer to children.

Each tablet contains the following dietary ingredients:

Iron (elemental) [from 324 mg Ferrous Fumarate]106 mg

Daily Values not established for patients with unique nutritional needs who are in need of supplementation as directed by a licensed medical practitioner.

Other Ingredients: Microcrystalline Cellulose (Kosher [KO]), HPMC 15cp, Polydextrose, Titanium Dioxide, Magnesium Stearate (Kosher [KO]), Silicon Dioxide (Kosher [KO]), Stearic Acid (Kosher [KO]), PEG 4000.

How Supplied: Supplied as oval, white tablets debossed with "V266" dispensed in boxes of 100 tablets (10 x 10 blister packs).

PRECAUTIONS/WARNING: KEEP THIS OUT OF REACH OF CHILDREN.

STORAGE: Store at controlled room temperature 15°-30°C (59°-86°F). [See USP]. Protect from light and moisture. Notice: Contact with moisture may produce surface discoloration or erosion.

HEALTH CLAIMS: Prescription Iron Containing Dietary Supplement

PRINCIPAL DISPLAY PANEL - 100 Blister Pack Carton Label

VIRTUS
PHARMACEUTICALS

NDC: 76439-266-10
Ferrous Fumarate
324 mg

IRON SUPPLEMENT

Iron (from 324 mg as Ferrous Fumarate)
Dietary Supplement

SAFETY SEALED:
DO NOT USE IF BLISTER SEAL IS BROKEN

Rx

100 Tablets        Made in the USA

(10 x 10 Blister Packs)

Principal Display Panel - 100 Blister Pack Carton Label
FERROUS FUMARATE 
ferrous fumarate tablet
Product Information
Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:76439-266
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FERROUS FUMARATE (UNII: R5L488RY0Q) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION106 mg
Inactive Ingredients
Ingredient NameStrength
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
HYPROMELLOSE 2910 (15 MPA.S) (UNII: 36SFW2JZ0W)  
POLYDEXTROSE (UNII: VH2XOU12IE)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
POLYETHYLENE GLYCOL 4000 (UNII: 4R4HFI6D95)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NHRIC:76439-266-10100 in 1 CARTON
110 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
DIETARY SUPPLEMENT07/29/201311/13/2014
Supplement Facts
Serving Size : Serving per Container :
Amount Per Serving% Daily Value
color
scoring1
shape
size (solid drugs)19 mm
imprint
Labeler - Virtus Pharmaceuticals LLC (969483143)

Revised: 9/2017
 
Virtus Pharmaceuticals LLC