Label: CHLORALUM- chloral hydrate pellet

  • Category: HUMAN PRESCRIPTION DRUG LABEL

DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

Drug Label Information

Updated March 7, 2011

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  • CONTROLLED SUBSTANCE


    Chloral Hydrate
  • PURPOSE

    INSOMNIA, EXCITABILITY,  OR OTHER INDICATIONS

  • KEEP OUT OF REACH OF CHILDREN

    WARNING: Keep this and all medications out of reach of children.

  • INDICATIONS & USAGE

    INDICATIONS: To be used according to standard homeopathic indications for self limiting conditions such as those indicated on the front panel or as directed by a physician.

    Free from yeast, wheat, corn, and soy.

  • WARNINGS

    WARNING: Used only if cap and seal are unbroken. If symptoms persist for more then 3 days, consult your physician. As with any drug, if your pregnant or nursing a baby, seek the advise of a health professional before using this product. Store tightly closed in a cool, dark place. Made according to The Homeopathic Pharmacopoeia of the United State by: Remedy Makers, Pomona, CA 91768.

  • DOSAGE & ADMINISTRATION

    DIRECTION: Dissolve 3 or 4 in mouth or tongue 3 times a day or as directed by a physician. Children 2 years and older take 1/2 adult dose.

  • INACTIVE INGREDIENT

    80% SUCROSE / 20% LACTOSE

  • PRINCIPAL DISPLAY PANEL

    CHLORALUM3X

  • INGREDIENTS AND APPEARANCE
    CHLORALUM 
    chloral hydrate pellet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:10191-1177
    Route of AdministrationSUBLINGUALDEA ScheduleCIV    
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLORAL HYDRATE (UNII: 418M5916WG) (CHLORAL - UNII:FLI06WS32H) CHLORAL HYDRATE3 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    SUCROSE (UNII: C151H8M554)  
    LACTOSE (UNII: J2B2A4N98G)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10191-1177-2172 in 1 VIAL, GLASS
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic02/04/2000
    Labeler - Remedy Makers (018543582)
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