Label: CODEINUM- codeine 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 July 17, 2015

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    CII

    Close
  • WARNING

    "The FDA has not determined that the product is safe, effective and not misbranded for its intended use"

    Close
  • INDICATION:

    VERTIGO, DIARRHEA, PAIN OR OTHER INDICATIONS

    Close
  • WARNING:

    Use only if cap and seal are unbroken. Keep this and all medication out of reach of children. If symptoms persist for more than 3 days or worsen, discontinue (STOP) use and consult your physician. As with any drug. If you are pregnant or nursing (breast-feeding) a baby, seek the advise of a health professional before using this product. Store tightly closed in a cool area.

    Close
  • Directions (adult/children)

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

    Close
  • Inactive Ingredients

    Lactose and Sucrose. Free from yeast, wheat, corn and soy.

    Close
  • Other Information

    Contains approx. 170 - 172 pellets.

    Close
  • Questions or comments:

    (877) REM4YOU Fax (909) 594-4205 Pomona, Ca. 91768 USA www.remedymakers.com

    Close
  • WARNINGS AND PRECAUTIONS

    CAUTION: Federal law prohibits dispensing withhout prescription.

    Close
  • INGREDIENTS AND APPEARANCE
    CODEINUM 
    codeine pellet
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10191-1035
    Route of Administration SUBLINGUAL DEA Schedule CII    
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CODEINE ANHYDROUS (UNII: UX6OWY2V7J) (CODEINE ANHYDROUS - UNII:UX6OWY2V7J) CODEINE ANHYDROUS 9 [hp_X]
    Inactive Ingredients
    Ingredient Name Strength
    SUCROSE (UNII: C151H8M554)  
    LACTOSE (UNII: J2B2A4N98G)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:10191-1035-2 170 in 1 VIAL, GLASS; Type 0: Not a Combination Product 07/14/2015
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved homeopathic 07/14/2015
    Labeler - Remedy Makers (018543582)
    Close