FE C TAB PLUS - iron pentacarbonyl, ascorbic acid, folic acid and cyanocobalamin capsule 
Boca Pharmacal, Inc.

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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FE C Tab Plus
Rx Only

Each Tablet Contains:

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

Carbonyl Iron ………………………………………………... 100 mg

Folic Acid ……………………………………………………     1 mg

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

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.

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]

Manufactured for:
Boca Pharmacal, Inc.
Coral Springs, FL 33065
1-800-354-8460
www.bocapharmacal.com

Rev.02/11

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

9cb72935-figure-01

[Rev. 5]

FE C TAB PLUS 
vitamin c (ascorbic acid), carbonyl iron, folic acid, vitamin b-12 (cyanocobalamin) capsule
Product Information
Product TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:64376-802
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IRON PENTACARBONYL (IRON PENTACARBONYL) IRON PENTACARBONYL100 mg
ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID250 mg
FOLIC ACID (FOLIC ACID) FOLIC ACID1 mg
CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN25 ug
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM 
ETHYLCELLULOSES 
FD&C RED NO. 40 
FD&C YELLOW NO. 6 
CELLULOSE, MICROCRYSTALLINE 
ANHYDROUS CITRIC ACID 
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS 
HYPROMELLOSES 
MALTODEXTRIN 
MAGNESIUM STEARATE 
MINERAL OIL 
POLYETHYLENE GLYCOLS 
STEARIC ACID 
TITANIUM DIOXIDE 
POVIDONE K29/32 
Product Characteristics
ColorBROWN (Maroon) Scoreno score
ShapeCAPSULESize19mm
FlavorImprint Code BP802
Contains    
Packaging
#Item CodePackage Description
1NDC:64376-802-01100 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other03/31/2011
Labeler - Boca Pharmacal, Inc. (170266089)
Registrant - Boca Pharmacal, Inc. (170266089)
Establishment
NameAddressID/FEIBusiness Operations
Cispharma, Inc.833171445MANUFACTURE

Revised: 01/2012
 
Boca Pharmacal, Inc.