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

Hydrate by

Drug Labeling and Warnings

Hydrate by is a Homeopathic medication manufactured, distributed, or labeled by Maplewood Company, Apotheca Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS:

Coffea Tosta 2X, 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 alternating with diarrhea, chronic myalgia, headache and low back pain.

WARNINGS:

​If pregnant or breast-feeding,​ ask a health care professinal 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.  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:

Celandine, Beet, Blessed Thistle, Boldo, Dandelion, Parsley, Demineralized Water, 25% Ethanol

KEEP OUT OF REACH OF CHILDREN:

​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 alternating with diarrhea, chronic myalgia, headache and low back pain.

QUESTIONS:

Manufactured For:

Maplewood Company

7334 S. Alton Way

Building #14, Ste. A

Centennial, CO 80112

PACKAGE DISPLAY LABEL:

HYDRATE II

HOMEOPATHIC

1 FL OZ (30 mL)

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51987-0002
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	2 [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 (UNII: 59677RXH25) (EQUISETUM HYEMALE - UNII:59677RXH25)	EQUISETUM HYEMALE	3 [hp_X]  in 1 mL
HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB)	HYPERICUM PERFORATUM	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 (UNII: 7E889U5RNN)
BEET (UNII: N487KM8COK)
CENTAUREA BENEDICTA FLOWERING TOP (UNII: NJN80GZ34N)
PEUMUS BOLDUS LEAF (UNII: Q4EWM09M3O)
TARAXACUM OFFICINALE (UNII: 39981FM375)
PETROSELINUM CRISPUM (UNII: 1WZA4Y92EX)
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51987-0002-1	30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	08/22/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		08/22/2013

Labeler - Maplewood Company (022963389)

Registrant - Apotheca Company (844330915)

Establishment
Name	Address	ID/FEI	Business Operations
Apotheca Company		844330915	manufacture(51987-0002) , api manufacture(51987-0002) , label(51987-0002) , pack(51987-0002)