Label: HELLEBORUS COMP. A liquid
- NDC Code(s): 48951-5136-3
- Packager: Uriel Pharmacy, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- 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 December 17, 2024
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- Official Label (Printer Friendly)
- INDICATIONS & USAGE
- DOSAGE & ADMINISTRATION
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ACTIVE INGREDIENT
Active Ingredients: Helleborus e pl. tota (christmas rose) 3X, Formica (red wood ant) 6X, Kalium phos. (potassium dihydrogenphosphate) 6X, Stibium met (antimony) 6X, Juglans reg. e fol. et fruct (walnut) 7X, Argentum met (silver) 8X, Phosphorus (yellow phosphorus) 12X, Stannum met. (metallic tin) 12X, Arsenicum album (white arsenic) 17X, Plumbum Silicicum (lead silicate) 20X
- INACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
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WARNINGS
Warnings: Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated. Contains traces of lactose. Do not use if allergic to any ingredient. Consult a doctor before use for serious conditions or if conditions worsen or persist. If pregnant or nursing, consult a doctor before use. Do not use if safety seal is broken or missing.
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
HELLEBORUS COMP. A
helleborus comp. a liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:48951-5136 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FORMICA RUFA (UNII: 55H0W83JO5) (FORMICA RUFA - UNII:55H0W83JO5) FORMICA RUFA 6 [hp_X] in 1 mL ANTIMONY (UNII: 9IT35J3UV3) (ANTIMONY - UNII:9IT35J3UV3) ANTIMONY 6 [hp_X] in 1 mL SILVER (UNII: 3M4G523W1G) (SILVER - UNII:3M4G523W1G) SILVER 8 [hp_X] in 1 mL HELLEBORUS FOETIDUS ROOT (UNII: 332Y7EES96) (HELLEBORUS FOETIDUS ROOT - UNII:332Y7EES96) HELLEBORUS FOETIDUS ROOT 3 [hp_X] in 1 mL POTASSIUM PHOSPHATE, MONOBASIC (UNII: 4J9FJ0HL51) (PHOSPHATE ION - UNII:NK08V8K8HR) POTASSIUM PHOSPHATE, MONOBASIC 6 [hp_X] in 1 mL ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC TRIOXIDE 17 [hp_X] in 1 mL TIN (UNII: 387GMG9FH5) (TIN - UNII:387GMG9FH5) TIN 12 [hp_X] in 1 mL PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS 12 [hp_X] in 1 mL JUGLANS REGIA LEAF (UNII: 85HKB87105) (JUGLANS REGIA LEAF - UNII:85HKB87105) JUGLANS REGIA LEAF 7 [hp_X] in 1 mL LEAD MONOSILICATE (UNII: TLE92T7F1J) (LEAD - UNII:2P299V784P) LEAD 20 [hp_X] in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G) SODIUM CHLORIDE (UNII: 451W47IQ8X) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:48951-5136-3 60 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product 09/01/2009 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 09/01/2009 Labeler - Uriel Pharmacy, Inc. (043471163) Establishment Name Address ID/FEI Business Operations Uriel Pharmacy, Inc. 043471163 manufacture(48951-5136)
