HYDRATE II- coffea tosta, avena sativa, equisetum hyemale, hypericum perforatum, ginkgo biloba, germanium sesquioxide, silicea, liquid 
Apotheca Company

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.

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DRUG FACTS:

Active Ingredients:  Coffea Tosta 1X, Avena Sativa 3X, Equisetum Hyemale 3X, Hypericum Perforatum 3X, Ginkgo Biloba 6X, Germanium Sesquioxide 8X, Silicea 8X.

Indications:  For temporary relief of dry mouth, dyspepsia, infrequent urination, constipation alternated with diarrhea, chronic myalgia, headaches and low back pain.


WARNINGS:  If pregnant or breast-feeding, ask a health care professional before use.

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.


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:  Beta Vulgaris, Cnicus Benedictus, Boldo, Chelidonium Majus, Taraxacum Officinale, Petroselinum Crispum, Demineralized Water, 25% Ethanol

KEEP OUT OF REACH OF CHILDREN.  In case of overdose, get medical help or contact a Poison Control Center right away.


INDICATIONS:  For temporary relief of dry mouth, dyspepsia, infrequent urination, constipation alternated with diarrhea, chronic myalgia, headaches and low back pain.


Distributed by:

BIOACTIVE NUTRITIONAL

Melbourne, FL 32935

For Nutritional Information write:

BioActive Nutritional, Inc.

1803 N. Wickham Rd.

Melbourne, FL 32935


BioActive Homeopathic

HYDRATE II

2 FL OZ (60 ml)

Hydrate II

HYDRATE  II
coffea tosta, avena sativa, equisetum hyemale, hypericum perforatum, ginkgo biloba, germanium sesquioxide, silicea, liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57520-0115
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVENA SATIVA FLOWERING TOP (UNII: MA9CQJ3F7F) (AVENA SATIVA FLOWERING TOP - UNII:MA9CQJ3F7F) AVENA SATIVA FLOWERING TOP3 [hp_X]  in 1 mL
EQUISETUM HYEMALE (UNII: 59677RXH25) (EQUISETUM HYEMALE - UNII:59677RXH25) EQUISETUM HYEMALE3 [hp_X]  in 1 mL
HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM3 [hp_X]  in 1 mL
GINKGO (UNII: 19FUJ2C58T) (GINKGO - UNII:19FUJ2C58T) GINKGO6 [hp_X]  in 1 mL
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE8 [hp_X]  in 1 mL
GERMANIUM SESQUIOXIDE (UNII: 96WE91N25T) (GERMANIUM SESQUIOXIDE - UNII:96WE91N25T) GERMANIUM SESQUIOXIDE8 [hp_X]  in 1 mL
ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72) ARABICA COFFEE BEAN1 [hp_X]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BETA VULGARIS (UNII: 4G174V5051)  
CENTAUREA BENEDICTA FLOWERING TOP (UNII: NJN80GZ34N)  
PEUMUS BOLDUS LEAF (UNII: Q4EWM09M3O)  
CHELIDONIUM MAJUS (UNII: 7E889U5RNN)  
TARAXACUM OFFICINALE (UNII: 39981FM375)  
PETROSELINUM CRISPUM (UNII: 1WZA4Y92EX)  
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57520-0115-160 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic02/22/201007/18/2016
Labeler - Apotheca Company (844330915)
Registrant - Apotheca Company (844330915)
Establishment
NameAddressID/FEIBusiness Operations
Apotheca Company844330915manufacture(57520-0115) , api manufacture(57520-0115) , label(57520-0115) , pack(57520-0115)

Revised: 7/2015
 
Apotheca Company