Label: HYDRATE II- coffea tosta, avena sativa, equisetum hyemale, hypericum performatum, ginkgo biloba, germanium sesquioxide, silicea liquid
- NDC Code(s): 43857-0080-1
- Packager: BioActive Nutritional, 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 September 1, 2023
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- ACTIVE INGREDIENTS:
- INDICATIONS:
- WARNINGS:
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DIRECTIONS:
Mix 3 parts water to one part juice, add 6 drops Hydrate II to 8 oz mixture or add 30 drops to a quart mixture. Drink 4 eight oz glasses daily in between meals. Drink Hydrate/water mixture for 6 days and then only water for one day. Repeat. After eight weeks begin drinking more pure water and less Hydrate/water mixture. Consult a physician for use in children under 12 years of age.
- INACTIVE INGREDIENTS:
- KEEP OUT OF REACH OF CHILDREN:
- INDICATIONS:
- QUESTIONS:
- PACKAGE LABEL DISPLAY:
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INGREDIENTS AND APPEARANCE
HYDRATE II
coffea tosta, avena sativa, equisetum hyemale, hypericum performatum, ginkgo biloba, germanium sesquioxide, silicea liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43857-0080 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength COFFEA ARABICA SEED, ROASTED (UNII: 9H58JRT35E) (COFFEA ARABICA SEED, ROASTED - UNII:9H58JRT35E) COFFEA ARABICA SEED, ROASTED 1 [hp_X] in 1 mL AVENA SATIVA FLOWERING TOP (UNII: MA9CQJ3F7F) (AVENA SATIVA FLOWERING TOP - UNII:MA9CQJ3F7F) AVENA SATIVA FLOWERING TOP 3 [hp_X] in 1 mL EQUISETUM HYEMALE WHOLE (UNII: 59677RXH25) (EQUISETUM HYEMALE WHOLE - UNII:59677RXH25) EQUISETUM HYEMALE WHOLE 3 [hp_X] in 1 mL HYPERICUM PERFORATUM WHOLE (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM WHOLE - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM WHOLE 3 [hp_X] in 1 mL GINKGO (UNII: 19FUJ2C58T) (GINKGO - UNII:19FUJ2C58T) GINKGO 6 [hp_X] in 1 mL GERMANIUM SESQUIOXIDE (UNII: 96WE91N25T) (GERMANIUM SESQUIOXIDE - UNII:96WE91N25T) GERMANIUM SESQUIOXIDE 8 [hp_X] in 1 mL SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE 8 [hp_X] in 1 mL Inactive Ingredients Ingredient Name Strength CHELIDONIUM MAJUS WHOLE (UNII: 7E889U5RNN) BEET (UNII: N487KM8COK) CENTAUREA BENEDICTA (UNII: 6L5ZL09795) PEUMUS BOLDUS LEAF (UNII: Q4EWM09M3O) TARAXACUM OFFICINALE ROOT (UNII: 9DE5YCO0RU) PARSLEY (UNII: 58FMD0Q0EV) WATER (UNII: 059QF0KO0R) ALCOHOL (UNII: 3K9958V90M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43857-0080-1 60 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product 08/16/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 02/18/2013 Labeler - BioActive Nutritional, Inc. (624980496) Registrant - Apotheca Company (844330915) Establishment Name Address ID/FEI Business Operations Apotheca Company 844330915 manufacture(43857-0080) , api manufacture(43857-0080) , label(43857-0080) , pack(43857-0080)
