Label: SP- brosimum acutifolium bark, himatanthus sucuuba bark, mansoa alliacea bark and leaf, minquartia guianenis bark, phyllanthus niruri whole liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 44911-0014-1 - Packager: Energique, 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 June 29, 2020
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- ACTIVE INGREDIENTS:
- INDICATIONS:
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WARNINGS:
If pregnant or breast-feeding, ask a health professional before use. Consult a physician for use in children under 12 years of age.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Do not use if tamper evident seal is broken or missing.
Store in a cool, dry place.
- KEEP OUT OF REACH OF CHILDREN:
- DIRECTIONS:
- INDICATIONS:
- INACTIVE INGREDIENTS:
- QUESTIONS:
- PACKAGE DISPLAY LABEL:
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INGREDIENTS AND APPEARANCE
SP
brosimum acutifolium bark, himatanthus sucuuba bark, mansoa alliacea bark and leaf, minquartia guianenis bark, phyllanthus niruri whole liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:44911-0014 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BROSIMUM ACUTIFOLIUM BARK (UNII: 8Q6X4504YC) (BROSIMUM ACUTIFOLIUM BARK - UNII:8Q6X4504YC) BROSIMUM ACUTIFOLIUM BARK 32 [hp_X] in 1 mL HIMATANTHUS LANCIFOLIUS BARK (UNII: 8O169FEF9T) (HIMATANTHUS LANCIFOLIUS BARK - UNII:8O169FEF9T) HIMATANTHUS LANCIFOLIUS BARK 32 [hp_X] in 1 mL MANSOA ALLIACEA BARK (UNII: 2H997JHQ75) (MANSOA ALLIACEA BARK - UNII:2H997JHQ75) MANSOA ALLIACEA BARK 32 [hp_X] in 1 mL MANSOA ALLIACEA LEAF (UNII: 63AYO2O03Y) (MANSOA ALLIACEA LEAF - UNII:63AYO2O03Y) MANSOA ALLIACEA LEAF 32 [hp_X] in 1 mL MINQUARTIA GUIANENSIS BARK (UNII: 8Q29UL9T9Z) (MINQUARTIA GUIANENSIS BARK - UNII:8Q29UL9T9Z) MINQUARTIA GUIANENSIS BARK 32 [hp_X] in 1 mL PHYLLANTHUS NIRURI WHOLE (UNII: NSN3MQO38G) (PHYLLANTHUS NIRURI WHOLE - UNII:NSN3MQO38G) PHYLLANTHUS NIRURI WHOLE 32 [hp_X] in 1 mL PIPER ADUNCUM LEAF (UNII: 718MWR54QO) (PIPER ADUNCUM LEAF - UNII:718MWR54QO) PIPER ADUNCUM LEAF 32 [hp_X] in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALCOHOL (UNII: 3K9958V90M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:44911-0014-1 120 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product 09/12/2013 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 09/12/2013 Labeler - Energique, Inc. (789886132) Registrant - Apotheca Company (844330915) Establishment Name Address ID/FEI Business Operations Apotheca Company 844330915 manufacture(44911-0014) , api manufacture(44911-0014) , label(44911-0014) , pack(44911-0014)
