Label: OPIUM- raw opium gum pellet
- NDC Code(s): 10191-1081-2
- Packager: Remedy Makers
- 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
- WARNING:
- INDICATION
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WARNING:
Use only if cap and seal are unbroken. Keep this and all medication out of reach of children. If symptoms persist 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 advice of a health professional before using this product. Store tightly closed in a cool area.
- Directions (adult/children)
- Inactive Ingredients:
- Questions or comments:
- Other Information:
- WARNINGS AND PRECAUTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
OPIUM
raw opium gum pelletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10191-1081 Route of Administration SUBLINGUAL DEA Schedule CII Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OPIUM (UNII: 37M3MZ001L) (OPIUM - UNII:37M3MZ001L) OPIUM 3 [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:10191-1081-2 160 in 1 VIAL, GLASS; Type 0: Not a Combination Product 05/21/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 05/21/2015 Labeler - Remedy Makers (018543582)
