Label: GENSTAT- aesculus hippocastanum, equisetum hyemale, fumaria officinalis, hydrocotyle asiatica, oleum olea europaea, passiflora incarnata, ribes nigrum, solidago virgaurea, ononis spinosa liquid
- NDC Code(s): 44911-0520-1
- 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 July 12, 2023
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- ACTIVE INGREDIENTS:
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INDICATIONS:
May temporarily relieve symptoms associated with general toxicity, such as the sudden desire to urinate, weakness and fatigue, increased mucus leading to cough or hoarseness, abdominal bloating, constipation alternating with diarrhea, muscle stiffness, soreness and pain.**
**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.
- WARNINGS:
- KEEP OUT OF REACH OF CHILDREN:
- DIRECTIONS:
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INDICATIONS:
May temporarily relieve symptoms associated with general toxicity, such as the sudden desire to urinate, weakness and fatigue, increased mucus leading to cough or hoarseness, abdominal bloating, constipation alternating with diarrhea, muscle stiffness, soreness and pain.**
**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.
- INACTIVE INGREDIENTS:
- QUESTIONS:
- PACKAGE LABEL DISPLAY:
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INGREDIENTS AND APPEARANCE
GENSTAT
aesculus hippocastanum, equisetum hyemale, fumaria officinalis, hydrocotyle asiatica, oleum olea europaea, passiflora incarnata, ribes nigrum, solidago virgaurea, ononis spinosa liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:44911-0520 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HORSE CHESTNUT (UNII: 3C18L6RJAZ) (HORSE CHESTNUT - UNII:3C18L6RJAZ) HORSE CHESTNUT 6 [hp_X] in 1 mL EQUISETUM HYEMALE WHOLE (UNII: 59677RXH25) (EQUISETUM HYEMALE - UNII:59677RXH25) EQUISETUM HYEMALE WHOLE 6 [hp_X] in 1 mL FUMARIA OFFICINALIS FLOWERING TOP (UNII: VH659J61ZL) (FUMARIA OFFICINALIS FLOWERING TOP - UNII:VH659J61ZL) FUMARIA OFFICINALIS FLOWERING TOP 6 [hp_X] in 1 mL CENTELLA ASIATICA WHOLE (UNII: 7M867G6T1U) (CENTELLA ASIATICA - UNII:7M867G6T1U) CENTELLA ASIATICA WHOLE 6 [hp_X] in 1 mL OLIVE OIL (UNII: 6UYK2W1W1E) (OLIVE OIL - UNII:6UYK2W1W1E) OLIVE OIL 6 [hp_X] in 1 mL PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA FLOWERING TOP - UNII:CLF5YFS11O) PASSIFLORA INCARNATA FLOWERING TOP 6 [hp_X] in 1 mL RIBES NIGRUM LEAF (UNII: Z46FSZ2M25) (RIBES NIGRUM LEAF - UNII:Z46FSZ2M25) RIBES NIGRUM LEAF 7 [hp_X] in 1 mL SOLIDAGO VIRGAUREA FLOWERING TOP (UNII: 5405K23S50) (SOLIDAGO VIRGAUREA FLOWERING TOP - UNII:5405K23S50) SOLIDAGO VIRGAUREA FLOWERING TOP 6 [hp_X] in 1 mL ONONIS SPINOSA WHOLE (UNII: RP8496915M) (ONONIS CAMPESTRIS - UNII:RP8496915M) ONONIS SPINOSA WHOLE 14 [hp_C] in 1 mL Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:44911-0520-1 120 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product 10/25/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 10/25/2019 Labeler - Energique, Inc. (789886132) Registrant - Apotheca Company (844330915) Establishment Name Address ID/FEI Business Operations Apotheca Company 844330915 manufacture(44911-0520) , api manufacture(44911-0520) , label(44911-0520) , pack(44911-0520)
