FE C TAB- iron, vitamin c 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.

----------

Unknown Title

FE C Tab

f14a4a6a-figure-01

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

f14a4a6a-figure-02
FE C TAB 
iron, vitamin c tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:64376-803
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID250 mg
IRON PENTACARBONYL (UNII: 6WQ62TAQ6Z) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION100 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
TRIACETIN (UNII: XHX3C3X673)  
Product Characteristics
ColorREDScoreno score
ShapeROUNDSize10mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64376-803-01100 in 1 BOTTLE; Type 0: Not a Combination Product08/19/201011/30/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER08/19/201011/30/2017
Labeler - Boca Pharmacal, LLC (170266089)
Establishment
NameAddressID/FEIBusiness Operations
Pharbest Pharmaceuticals, Inc.557054835MANUFACTURE(64376-803, 64376-803)

Revised: 9/2013
 
Boca Pharmacal, LLC