Label: FERROUS SULFATE elixir

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

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Drug Label Information

Updated April 30, 2018

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

    Ferrous Sulfate 220 mg (44 mg of elemental Iron)

  • Purpose

    Iron Supplement

    Uses

    a therapy for simple iron deficiency and iron deficiency anemia

  • 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 over1 teaspoonful daily, or as directed by a physician
    Children under 12 years of ageConsult a physician
  • Inactive ingredients

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

  • Other information

    Store in tight, light-resistant container at room temperature
  • PRINCIPAL DISPLAY PANEL

    PRINCIPAL DISPLAY PANEL

  • INGREDIENTS AND APPEARANCE
    FERROUS SULFATE 
    ferrous sulfate elixir
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53807-177
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    FERROUS SULFATE (UNII: 39R4TAN1VT) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION220 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SUCROSE (UNII: C151H8M554)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorORANGEScore    
    ShapeSize
    FlavorPEPPERMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53807-177-08236 mL in 1 BOTTLE; Type 0: Not a Combination Product03/16/1999
    2NDC:53807-177-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product03/16/1999
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED DRUG OTHER03/16/1999
    Labeler - Rij Pharmaceutical Corporation (144679156)
    Establishment
    NameAddressID/FEIBusiness Operations
    Rij Pharmaceutical Corporation144679156manufacture(53807-177)