Label: TOP CARE CASTOR OIL- castor oil oil

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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.

Drug Label Information

Updated March 17, 2022

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  • ACTIVE INGREDIENT

    Castor Oil

  • PURPOSE

    Stimulant Laxative

  • INDICATIONS & USAGE

    For relief of occasional constipation. Bowel movement is generally produced in 6 to 12 hours.

  • WARNINGS

    Do not use when abdominal pain, nausea, or vomiting are present unless directed by a doctor.

  • KEEP OUT OF REACH OF CHILDREN

    In case of accidental overdose, seek profssional assistance or contact a Poison Control Center immediately.

  • DOSAGE & ADMINISTRATION

    Preferably take on an empty stomach. May be taken with juice to improve taste.

    Adults and children 12 yrs. of age and older: 15 to 60 milliliters in a single daily dose or as directed by a doctor.

    Children 2 to under 12 yrs. of age: 5 to 15 milliliters in a single dose or as directed by a doctor.

    Children under 2 yrs. of age: Consult a doctor before use.

  • INACTIVE INGREDIENT

    None

  • PRINCIPAL DISPLAY PANEL

    Top Care Castor OilTC Castor Oil.jpg

  • INGREDIENTS AND APPEARANCE
    TOP CARE CASTOR OIL 
    castor oil oil
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-270
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CASTOR OIL (UNII: D5340Y2I9G) (CASTOR OIL - UNII:D5340Y2I9G) CASTOR OIL1 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:36800-270-96177 mL in 1 CONTAINER; Type 0: Not a Combination Product07/16/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33407/16/2019
    Labeler - TOPCO ASSOCIATES LLC (006935977)
    Registrant - Pharma Nobis, LLC (118564114)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharma Nobis, LLC118564114manufacture(36800-270) , pack(36800-270) , label(36800-270) , analysis(36800-270)
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