FERROCITE
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ferrous fumarate tablet, film coated
Breckenridge Pharmaceutical, Inc.
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Microcrystalline Cellulose, Citric Acid, Croscarmellose Sodium, Stearic Acid, Magnesium Stearate, Hypromellose, Magnesium Silicate, Titanium Dioxide, Triacetin, Mineral Oil, FD&C Yellow No. 5 Lake1, Sodium Lauryl Sulfate, FD&C Blue No.1 Lake.
Do not exceed recommended dosage.
The dietary supplementation of any anemic condition should be under the advice and supervision of a physician. Since oral iron products interfere with absorption of certain antibiotics, these products should not be taken within two hours of each other. Consult your doctor before use if you have, or have had, any health condition or if you are taking any medications (prescription or OTC).
Gastrointestinal disturbance (anorexia, nausea, diarrhea, constipation) occur occasionally, but are usually mild and subside with continuation of therapy.
This product contains FD&C Yellow No. 5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible persons. Although the overall incidence of FD&C Yellow No. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity.
Ferrocite™ Tablets are round, green, film-coated tablets debossed B181. Ferrocite™ is supplied in boxes of 100 tablets (4 × 25). NDC# 51991-181-42.
Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F). See USP Controlled Room Temperature. Keep in a cool, dry place.
All prescription substitutions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product.
WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately. |
These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease. |
Manufactured by: Contract Pharmacal Corp., Hauppauge, NY 11788 USA
Distributed by: Breckenridge Pharmaceutical, Inc
Boca Raton, FL 33487
To report serious adverse events, or for product information contact: 1-800-367-3395.
Rev. 06/09
Breckenridge
Pharmaceutical, Inc
NDC 51991-181-42
Ferrocite™
Tablets
Iron (from 324 mg as Ferrous Fumarate)
Dietary Supplement
SAFETY SEALED:
DO NOT USE IF BLISTER SEAL IS BROKEN.
100 TABLETS
(4 Blister Cards with 25 Tablets each)
FERROCITE
ferrous fumarate tablet, film coated |
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Marketing Information | |||
Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
Dietary Supplement | 07/01/2003 | 12/31/2011 |
Labeler - Breckenridge Pharmaceutical, Inc. (150554335) |
Establishment | |||
Name | Address | ID/FEI | Operations |
Contract Pharmacal Corporation | 057795122 | MANUFACTURE |
Revised: 06/2012 Breckenridge Pharmaceutical, Inc.