Label: OPIUM- raw opium gum pellet
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Contains inactivated NDC Code(s)
NDC Code(s): 10191-1093-2 - 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 8, 2011
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- CONTROLLED SUBSTANCE
- INDICATIONS & USAGE
- WARNINGS
- INDICATIONS & USAGE
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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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- INACTIVE INGREDIENT
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INGREDIENTS AND APPEARANCE
OPIUM
raw opium gum pelletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10191-1093 Route of Administration SUBLINGUAL DEA Schedule CII Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OPIUM (UNII: 37M3MZ001L) (OPIUM - UNII:37M3MZ001L) OPIUM 30 [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:10191-1093-2 137 in 1 VIAL, GLASS Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 11/21/2001 Labeler - Remedy Makers (018543582)