QUALITY CHOICE CASTOR OIL (CASTOR OIL) LIQUID [CHAIN DRUG MARKET ASOCIATION]

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QUALITY CHOICE CASTOR OIL (CASTOR OIL) LIQUID [CHAIN DRUG MARKET ASOCIATION]
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NDC 63868-322-06
Set ID 18d7124f-7745-45b2-adc4-cb1103add5d6
Category HUMAN OTC DRUG LABEL
Packager Chain Drug Market Asociation
Generic Name
Product Class
Product Number
Application Number PART334
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Castor Oil

  • Purpose

    Stimulant Laxative

  • Use

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

  • Warings

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

  • Ask a doctor before use

    if you have noticed a sudden change in bowel habits that persists over a period of 2 weeks. Laxative products should not be used for a period of longer than 1 week unless directed by a doctor. Frequent or prolonged use may result in the dependence on laxatives.

  • When using this product

    Discontinue use and consult a doctor if you have rectal bleeding or failure to have a bowel movement after the use of a laxative. The symptoms may indicate a serious condition.

  • If pregnant or breast feeding

    ask a health professional before use

  • Keep out of reach of children.

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

  • Directions

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

    Adults and children 12 yrs. of age and older: 1 to 4 tablesponfuls in a single daily dose or as directed by a doctor.

    Children 2 to under 12 yrs. of age: 1 to 3 teaspoonfuls in a single dose or as directed by a doctor.

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

  • WARNINGS:

    Do not use if Taper Evident Seal is broken or missing. This product is sealed with either a shrink band around cap imprinted "Sealed For your Protection" or foil seal under cap.

  • Other Information

    storage. Keep tightly closed and away from excessive heat.

  • Inactive Ingredient

    None

  • PRINCIPAL DISPLAY PANEL

    Label 6 oz

    Label 6 oz

  • INGREDIENTS AND APPEARANCE
    QUALITY CHOICE CASTOR OIL 
    castor oil liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-322
    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:63868-322-06177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/12/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33401/01/2008
    Labeler - Chain Drug Market Asociation (011920774)
    Registrant -  Humco Holding Group, Inc. (825672884)
    Establishment
    NameAddressID/FEIBusiness Operations
    Humco Holding Group, Inc.825672884manufacture(63868-322) , analysis(63868-322) , pack(63868-322) , label(63868-322)
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