FE C Tab Plus

Generic Name: vitamin c (ascorbic acid), carbonyl iron, folic acid, vitamin b-12 (cyanocobalamin)
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.

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.

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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, LLC

Coral Springs, FL 33065

1-800-354-8460

www.bocapharmacal.com

Rev. 08/13

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FE C Tab Plus 
vitamin c (ascorbic acid), carbonyl iron, folic acid, vitamin b-12 (cyanocobalamin) tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:64376-802
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 250 mg
FOLIC ACID (FOLIC ACID) FOLIC ACID 1 mg
CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN 25 ug
IRON PENTACARBONYL (FERROUS CATION) FERROUS CATION 100 mg
Inactive Ingredients
Ingredient Name Strength
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
Color BROWN (Maroon) Score no score
Shape CAPSULE Size 19mm
Flavor Imprint Code BP802
Contains         
Packaging
# Item Code Package Description
1 NDC:64376-802-01 100 TABLET (TABLET) in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 03/31/2011
Labeler - Boca Pharmacal, LLC (170266089)
Registrant - Boca Pharmacal, LLC (170266089)
Revised: 09/2013
 
Boca Pharmacal, LLC



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