Ferrocite

Dosage form: tablet, film coated
Ingredients: Ferrous Fumarate 106mg
Labeler: Breckenridge Pharmaceutical, Inc.
NDC Code: 51991-181

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Ferrocite™ Tablets

Supplement Facts
Serving Size: 1 Tablet
Amount Per Tablet% Daily Value
Iron (from 324 mg as Ferrous Fumarate)106 mg588%

Inactive Ingredients

Microcrystalline Cellulose, Citric Acid, Croscarmellose Sodium, Stearic Acid, Magnesium Stearate, Hypromellose, Magnesium Silicate, Titanium Dioxide, Triacetin, Mineral Oil, FD&C Yellow No. 5 Lake, Sodium Lauryl Sulfate, FD&C Blue No.1 Lake.


Contains FD&C Yellow No. 5 Lake (Tartrazine) as a color additive (see Precautions).

Warnings

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.

If pregnant, or planning to become pregnant or are currently breast-feeding please contact your physician, or health-care provider before using or continuing use.

Precautions

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.

Directions

Adults

1 tablet daily, between meals, orally. Do not exceed recommended dosage. Do not administer to children.

HOW SUPPLIED

Ferrocite™ Tablets are round, green, film-coated tablets debossed B181. Ferrocite™ is supplied in boxes of 100 tablets (4 × 25). NDC# 51991-181-42.

STORAGE

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

PRINCIPAL DISPLAY PANEL - 100 Tablets Carton

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
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51991-181
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Ferrous Fumarate (Iron) Iron106 mg
Inactive Ingredients
Ingredient NameStrength
Cellulose, Microcrystalline 
Citric Acid Monohydrate 
Croscarmellose Sodium 
Stearic Acid 
Magnesium Stearate 
Hypromellose 
Magnesium Aluminum Silicate 
Titanium Dioxide 
Triacetin 
Mineral Oil 
FD&C Yellow No. 5 
Aluminum Oxide 
Sodium Lauryl Sulfate 
FD&C Blue No. 1 
Product Characteristics
ColorGREENScoreno score
ShapeROUNDSize10mm
FlavorImprint Code B181
Contains    
Packaging
#Item CodePackage Description
1NDC:51991-181-42100 TABLET, FILM COATED (TABLET) in 1 BOX, UNIT-DOSE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35707/01/2003
Labeler - Breckenridge Pharmaceutical, Inc. (150554335)
Establishment
NameAddressID/FEIOperations
Contract Pharmacal Corporation057795122MANUFACTURE

Revised: 10/2009
 
Breckenridge Pharmaceutical, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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