Label: OPIUM- raw opium gum 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, 2023

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  • SPL UNCLASSIFIED SECTION

    CII

  • WARNING:

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

  • INDICATION:

    VERTIGO, DIARRHEA, PAIN, OR OTHER INDICATIONS

  • WARNING:

    Use only if cap and seal are unbroken. Keep this and all medications 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.

  • Directions (adult/children)

    Disolve 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.

  • Other Information:

    Contains approx. 166 - 169 pellets.

  • WARNINGS AND PRECAUTIONS

    CAUTION: Federal law prohibits dispensing without prescription.

  • PRINCIPAL DISPLAY PANEL

    OPIUM6C

  • INGREDIENTS AND APPEARANCE
    OPIUM 
    raw opium gum pellet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:10191-1089
    Route of AdministrationSUBLINGUALDEA ScheduleCII    
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OPIUM (UNII: 37M3MZ001L) (OPIUM - UNII:37M3MZ001L) OPIUM6 [hp_C]
    Inactive Ingredients
    Ingredient NameStrength
    SUCROSE (UNII: C151H8M554)  
    LACTOSE (UNII: J2B2A4N98G)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10191-1089-2166 in 1 VIAL, GLASS; Type 0: Not a Combination Product07/09/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic07/09/2015
    Labeler - Remedy Makers (018543582)
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