Label: CODEINUM - codeine base pellet

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: CII
  • Marketing Status: unapproved homeopathic

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


    Codeine Base
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  • INDICATIONS & USAGE

    ITCHING WITH WARMTH, SPASMODIC COUGH, OR OTHER INDICATIONS

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  • WARNINGS

    WARNING :Keep this and all medications out of reach of children. Close
  • INDICATIONS & USAGE

    INDICATIONS: To be use according to standard homeopathic indications,or as prescribed by a licensed physician.

    Free from yeast, wheat, corn, and soy.

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  • WARNINGS

    WARNING SECTION: Use only if cap and seal are unbroken. If symptoms persist for more than 3 days, contact your physician or pharmacist. Do not take if you are pregnant or nursing a baby. Store tightly closed in a cool, dark place. Made according to The Homeopathic Pharmacopoeia of the United State by: Remedy Makers, Pomona, CA 91768 

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  • DOSAGE & ADMINISTRATION

    USUAL DOSAGE: Dissolve 3 or 4 pellets in mouth or tongue as prescribed by a licensed  physician. Children 2 years and younger take 1/2 the adult dose

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  • INACTIVE INGREDIENT

    80% SUCROSE / 20% LACTOSE

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  • INGREDIENTS AND APPEARANCE
    CODEINUM 
    codeine base pellet
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10191-1045
    Route of Administration SUBLINGUAL DEA Schedule CII    
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CODEINE (UNII: Q830PW7520) (CODEINE - UNII:Q830PW7520) CODEINE 100 [hp_C]
    Inactive Ingredients
    Ingredient Name Strength
    SUCROSE (UNII: C151H8M554)  
    LACTOSE (UNII: J2B2A4N98G)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:10191-1045-2 148 in 1 VIAL, GLASS
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved homeopathic 04/23/2008
    Labeler - Remedy Makers (018543582)
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