FE C Tablets

Generic Name: iron, vitamin c
Dosage Form: tablet

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

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.

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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

FE C TAB 
iron, vitamin c tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:64376-803
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 250 mg
IRON PENTACARBONYL (FERROUS CATION) FERROUS CATION 100 mg
Inactive Ingredients
Ingredient Name Strength
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
Color RED Score no score
Shape ROUND Size 10mm
Flavor Imprint Code
Contains         
Packaging
# Item Code Package Description
1 NDC:64376-803-01 100 TABLET (TABLET) in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 08/19/2010
Labeler - Boca Pharmacal, LLC (170266089)
Registrant - Boca Pharmacal, LLC (170266089)
Revised: 09/2013
 
Boca Pharmacal, LLC



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