Skip to main content

FE C Tablets

Generic name: iron, vitamin c
Dosage form: tablet
Drug class: Vitamin and mineral combinations

Medically reviewed by Drugs.com. Last updated on Aug 23, 2021.

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.

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.

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 in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 08/19/2010 11/30/2017
Labeler - Boca Pharmacal, LLC (170266089)
Establishment
Name Address ID/FEI Operations
Pharbest Pharmaceuticals, Inc. 557054835 MANUFACTURE(64376-803, 64376-803)
Boca Pharmacal, LLC