FE C TAB PLUS- ascorbic acid, folic acid, cyanocobalamin and iron pentacarbonyl tablet 
Boca Pharmacal, LLC

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Unknown Title

FE C Tab Plus

Rx Only

Each Tablet Contains:

Vitamin C (Ascorbic  Acid) …………………. 250mg

Carbonyl Iron ……………………………………….100mg

Folic Acid ………………………………………………..1mg

Vitamin B-12 (Cyanocobalamin) ………… 25mcg

DIRECTIONS: Adults and Children 12 years and over – One tablet daily or as directed by a physician. Children under 12 years: Consult a physician.

WARNINGS: Do not exceed recommended dosage. The treatment of any anemic condition should be under the advice and supervision of a physician. Since oral iron products interfere with absorption of oral tetracycline antibiotics, these products should not be taken within two hours of each other. Occasional gastrointestinal discomfort (such as nausea) may be minimized by taking with meals. Iron products may occasionally cause constipation or diarrhea. If you are pregnant or nursing a baby, seek the advice of a health professional before using this product.

BOXED WARNING

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

Inactive Ingredients Include: Citric Acid Anhydrous, Croscarmellose Sodium, Dicalcium Phosphate, Ethyl Cellulose, FD&C Red #40 Lake, FD&C Yellow #6 Lake, Hypromellose, Maltodextrin, Magnesium Stearate, Microcrystalline Cellulose, Mineral Oil, Polyethylene Glycol, Polyvinylpyrrolidone, Stearic Acid, Titanium Dioxide.

Store at Controlled Room Temperature 20º-25ºC [68º-77ºF]; [See USP Controlled Room Temperature]

a48d1ddc-figure-01

Manufactured for:

Boca Pharmacal, LLC

Coral Springs, FL 33065

1-800-354-8460

www.bocapharmacal.com

Rev. 08/13

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

a48d1ddc-figure-02
FE C TAB PLUS 
vitamin c ascorbic acid, carbonyl iron, folic acid, vitamin b-12 cyanocobalamin tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:64376-802
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID250 mg
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID1 mg
CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN25 ug
IRON PENTACARBONYL (UNII: 6WQ62TAQ6Z) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION100 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
ETHYLCELLULOSES (UNII: 7Z8S9VYZ4B)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MINERAL OIL (UNII: T5L8T28FGP)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
POVIDONE K29/32 (UNII: 390RMW2PEQ)  
Product Characteristics
ColorBROWN (Maroon) Scoreno score
ShapeCAPSULESize19mm
FlavorImprint Code BP802
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64376-802-01100 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER03/31/201109/30/2015
Labeler - Boca Pharmacal, LLC (170266089)
Registrant - Boca Pharmacal, LLC (170266089)

Revised: 9/2013
 
Boca Pharmacal, LLC