FE C Tab description, usages, side effects, indications, overdosage, supplying and lots more!

FE C Tab

Boca Pharmacal, LLC
Boca Pharmacal, LLC

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert
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FULL PRESCRIBING INFORMATION

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

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 250 mg
IRON PENTACARBONYL 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 Size Shape
RED 10 mm ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:64376-803-01 100 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
2010-08-19


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