FE C TAB - ascorbic acid 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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FE C Tab

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Inactive ingredients: Black iron oxide, dicalcium phosphate, FD&C Blue #2, FD&C Red #40, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, propylene glycol, red iron oxide, silicon dioxide, stearic acid, titanium dioxide, triacetin, yellow iron oxide.

STORE AT CONTROLLED ROOM TEMPERATURE 20°-25°C (68°-77°F)

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.

DO NOT ACCEPT IF IMPRINTED SEAL UNDER CAP IS BROKEN OR MISSING.

Manufactured for: Boca Pharmacal, LLC Coral Springs, FL 33065
www.bocapharmacal.com    1-800-354-8460  Rev. 08/13     077T

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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FE C TAB 
iron, vitamin c tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:64376-803
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID250 mg
IRON PENTACARBONYL (FERROUS CATION) FERROUS CATION100 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE 
STEARIC ACID 
FERROSOFERRIC OXIDE 
TITANIUM DIOXIDE 
HYPROMELLOSES 
FD&C BLUE NO. 2 
CELLULOSE, MICROCRYSTALLINE 
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS 
MAGNESIUM STEARATE 
POLYETHYLENE GLYCOLS 
FD&C RED NO. 40 
FERRIC OXIDE RED 
FERRIC OXIDE YELLOW 
PROPYLENE GLYCOL 
TRIACETIN 
Product Characteristics
ColorREDScoreno score
ShapeROUNDSize10mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64376-803-01100 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other08/19/2010
Labeler - Boca Pharmacal, LLC (170266089)
Registrant - Boca Pharmacal, LLC (170266089)

Revised: 9/2013
Document Id: f14a4a6a-8425-4d82-a904-654a49572f06
Set id: c81325e0-c2db-4412-89a9-236a6733f229
Version: 3
Effective Time: 20130924
 
Boca Pharmacal, LLC