Label: ENTERIC COATED FERROUS SULFATE- ferrous sulfate tablet, coated

  • Category: DIETARY SUPPLEMENT
  • DEA Schedule: None
  • Marketing Status: Dietary Supplement

Drug Label Information

Updated November 27, 2024

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  • STATEMENT OF IDENTITY

    Supplement Facts
    Serving Size: 1 Tablet
    Amount Per Serving% Daily Value
    Iron (as ferrous sulfate) 65 mg362%

    Other ingredients: carmine, croscarmellose sodium, dicalcium phosphate, hypromellose, isomalt, magnesium stearate, methacrylic acid copolymer, microcrystalline cellulose, riboflavin, rice starch, silicon dioxide, sodium lauryl sulfate, sodium starch glycolate, stearic acid, talc, triacetin, triglycerides

  • DOSAGE & ADMINISTRATION

    Directions: Adults and children 12 years of age and over: Take one tablet daily, preferably after a meal, or as directed by a physician. Children under 12 years of age: Consult a physician. Do not chew or crush tablet.

    Tablets are enteric-coated to help protect your stomach.

  • SAFE HANDLING WARNING

    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 (800-222-1222).

  • WARNINGS

    Warnings: Do not take within 2 hours of taking oral tetracycline antibiotics, since oral iron products tend to interfere with absorption of tetracycline. May cause gastrointestinal discomfort, nausea, constipation or diarrhea. If you are pregnant or nursing a baby, seek advice of a health professional before using this product. U.S. Consumer Product Safety Commission requires that iron-containing medicine and vitamins with iron be packaged in child-resistant closures. Parents should always use properly re-secure safety closures.

  • SAFE HANDLING WARNING

    Storage: Store at 20° - 25°C (68° - 77°F) (see USP Controlled Room Temperature)

  • HEALTH CLAIM

    Questions or Comments? (866)562-2756 (Mon-Fri 8 AM to 4 PM EST)

  • HEALTH CLAIM

    †This product is manufactured in a facility which shares manufacturing equipment used for manufacturing other product containing titanium dioxide.

  • HEALTH CLAIM

    TAMPER EVIDENT: DO NOT USE IF SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

  • HEALTH CLAIM

    Distributed by:
    ULAI HEALTH LLC., Alexandria, VA 22312

    Org. 1024

    More Supplement Facts

  • PRINCIPAL DISPLAY PANEL

    PHARBEST

    Manufactured in the USA

    73057-411-08

    Enteric Coated

    IRON

    Elemental Iron 65 mg

    Titanium Dioxide Free†

    Supports Red Blood Cell Production††

    100 Tablets

    Principal Display Panel - Ulai Enteric Coated Ferrous Sulfate Tablet Product Label

  • INGREDIENTS AND APPEARANCE
    ENTERIC COATED FERROUS SULFATE 
    ferrous sulfate tablet, coated
    Product Information
    Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:73057-411
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    FERROUS SULFATE (UNII: 39R4TAN1VT) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION65 mg
    Inactive Ingredients
    Ingredient NameStrength
    PIGMENT RED 5 (UNII: 91OZU993LX)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    ISOMALT (UNII: S870P55O2W)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) (UNII: 74G4R6TH13)  
    MICROCRYSTALLINE CELLULOSE 102 (UNII: PNR0YF693Y)  
    RIBOFLAVIN (UNII: TLM2976OFR)  
    STARCH, RICE (UNII: 4DGK8B7I3S)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    TRIACETIN (UNII: XHX3C3X673)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:73057-411-08100 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    DIETARY SUPPLEMENT10/16/2024
    Supplement Facts
    Serving Size : Serving per Container :
    Amount Per Serving% Daily Value
    color
    scoring1
    shape
    size (solid drugs)10 mm
    Labeler - Ulai Health LLC (081181535)
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