Label: FERROUS SULFATE - ferrous sulfate tablet

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

Drug Label Information

Updated 09/13

If you are a consumer or patient please visit this version.

  • BOXED WARNING(What is this?)

    BOXED WARNING

    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.

    Close
  • DESCRIPTION

    Supplement Facts

    Serving Size: 1 Tablet
    Amount Per Tablet % Daily Value
    Iron 65 mg 361 %

    Other ingredients: Calcium phosphate, cellulose, croscarmellose sodium, FD&C red #40, hypromellose, magnesium stearate, mineral oil, polyethylene glycol, sodium starch glycolate, stearic acid (veg. grade), talc, and titanium dioxide.

    Formula: Each tablet contains 200 mg of dried ferrous sulfate USP (65 mg of elemental iron), equivalent to 325 mg of ferrous sulfate USP.

    Close
  • DOSAGE AND ADMINISTRATION

    Directions: Adults and children over 12 years of age: 1 tablet daily as a dietary supplement, preferably with a meal or as directed by a doctor. Do not exceed 2 tablets in 24 hours. Not for frequent or prolonged use except on the advice of a doctor. Do not give to children under 12 years of age. Do not exceed recommended dosage.

    Caution: Since oral iron products interfere with absorption of certain antibiotics, these products should not be taken within two hours of each other. If you are pregnant, nursing or taking any medications, consult your doctor before use. Discontinue use and consult your doctor if any adverse reactions occur.

    Close
  • HOW SUPPLIED

    Storage and Handling

    STORE AT 20°- 25°C (68° - 77°F); Excursions permitted to 15°- 30°C (59° - 86°F), see USP Controlled Room Temperature. Store away from heat and moisture. Keep tightly closed.

    Tamper resistant: Do not use if seal under cap is broken or missing.

    Manufactured for:
    Boca Pharmacal, LLC
    Coral Springs, FL 33065
    www.bocapharmacal.com
    1-800-354-8460
    Rev. 09/13

    Close
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Ferrous Sulfate Tablets, USP 325mg

    1000ct

    NDC: 64376-809-10

    a751fe4b-figure-01

    [Rev. 10]

    Close
  • INGREDIENTS AND APPEARANCE
    FERROUS SULFATE 
    iron tablet
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:64376-809
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    FERROUS SULFATE (FERROUS CATION) FERROUS CATION 65 mg
    Inactive Ingredients
    Ingredient Name Strength
    TALC  
    TITANIUM DIOXIDE  
    HYPROMELLOSES  
    MAGNESIUM STEARATE  
    POLYETHYLENE GLYCOLS  
    MINERAL OIL  
    CALCIUM PHOSPHATE  
    CROSCARMELLOSE SODIUM  
    FD&C RED NO. 40  
    POWDERED CELLULOSE  
    STEARIC ACID  
    SODIUM STARCH GLYCOLATE TYPE A POTATO  
    Product Characteristics
    Color RED Score no score
    Shape ROUND Size 10mm
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:64376-809-10 1000 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    Unapproved drug other 09/14/2010
    Labeler - Boca Pharmacal, LLC (170266089)
    Registrant - Boca Pharmacal, LLC (170266089)
    Close