Label: CODEINUM- codeine pellet
- NDC Code(s): 10191-1037-2
- 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
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- 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 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 tiightly closed in a cool area.
- Directions (adult/children)
- Inactive Ingredients
- Other Information
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- WARNINGS AND PRECAUTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
CODEINUM
codeine pelletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10191-1037 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 15 [hp_X] Inactive Ingredients Ingredient Name Strength LACTOSE (UNII: J2B2A4N98G) SUCROSE (UNII: C151H8M554) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10191-1037-2 166 in 1 VIAL, GLASS; Type 0: Not a Combination Product 07/16/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 07/16/2015 Labeler - Remedy Makers (018543582)
