Label: FERROUS SULFATE- ferrous sulfate elixir 

  • Label RSS
  • NDC Code(s): 53807-177-08, 53807-177-16
  • Packager: Rij Pharmaceutical Corporation
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 04/13

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  • Active ingredient (in each 5 mL) (one teaspoonful)

    Ferrous Sulfate 220 mg (44 mg of elemental Iron)

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  • Purpose

    Iron Supplement

    Uses

    a therapy for simple iron deficiency and iron deficiency anemia

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  • Warnings

    Adverse Reactions:

    occasional gastrointestinal discomfort such as nausea dose related bowel effects (such as constipation or diarrhea), gastrointestinal effects may be minimized by the administration with or immediately after meals and bowel effects reduced by giving the minimum effective dosage.

    Do not use

    • more than directed

    The treatment of any anemic condition should be under the advice and supervision of a physician

    Ask a doctor or pharmacist before use if you are

    taking oral Tetracycline antibiotics. Oral iron products interfere with absorption of oral tetracycline antibiotics. These products should not be taken within two hours of each other.

    When using this product

    • may occasionally cause constipation or diarrhea
    • may cause temporary staining of the teeth (this is less likely when diluted)

    If pregnant or breast-feeding

    ask a health professional before use.

    Keep this and all drugs out of reach of children.

    Contains iron, which can be harmful or fatal to children in large doses. In case of accidental overdose, seek professional assistance or contact a Poison Control Center right away.

    Treatment of overdose:

    quickly induce vomiting, then feed eggs and milk until gastric lavage can be done. Lavage with 1 percent Sodium Bicarbonate and administer an iron chelating agent (such as deferoxamine mesylate) BAL should not be used. Gastric lavage should not be performed after the first hour because the danger of perforation due to gastric necrosis. Measures to combat shock, dehydration, blood loss and respiratory failure may be necessary.

    Directions

    Mix with water or fruit juice to avoid temporary staining of the teeth, do not mix with milk or wine-based vehicles

    Adults and children 12 years of age and over 1 teaspoonful daily, or as directed by a physician
    Children under 12 years of age Consult a physician
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  • Inactive ingredients

    citric acid, FD & C yellow #6, flavor, sodium benzoate, sucrose and water.

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  • Other information

    Store in tight, light-resistant container at room temperature
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  • PRINCIPAL DISPLAY PANEL
  • INGREDIENTS AND APPEARANCE
    FERROUS SULFATE 
    ferrous sulfate elixir
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:53807-177
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    FERROUS SULFATE (FERROUS CATION) FERROUS CATION 220 mg  in 5 mL
    Inactive Ingredients
    Ingredient Name Strength
    CITRIC ACID MONOHYDRATE  
    FD&C YELLOW NO. 6  
    SODIUM BENZOATE  
    SUCROSE  
    WATER  
    Product Characteristics
    Color ORANGE Score     
    Shape Size
    Flavor PEPPERMINT Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:53807-177-08 236 mL in 1 BOTTLE
    2 NDC:53807-177-16 473 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    UNAPPROVED DRUG OTHER 03/16/1999
    Labeler - Rij Pharmaceutical Corporation (144679156)
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