Drug Facts:

Drug Facts:
SPL v4
SPL
SPL Set ID c0c8d350-0257-4484-acd8-f852350173db
Route
ORAL
Published
Effective Date 2021-05-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Coffea Arabica Seed, Roasted (1 [hp_X]) Ginkgo (6 [hp_X]) Germanium Sesquioxide (8 [hp_X]) Silicon Dioxide
Inactive Ingredients
Chelidonium Majus Beta Vulgaris Centaurea Benedicta Flowering Top Peumus Boldus Leaf Taraxacum Officinale Root Parsley Water Alcohol

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2013-09-11

Description

Coffea Tosta 1X, Ginkgo Biloba 6X, Germanium Sesquioxide 8X, Silica 8X.


Medication Information

Description

Coffea Tosta 1X, Ginkgo Biloba 6X, Germanium Sesquioxide 8X, Silica 8X.

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.

Questions:

Distributed by:

BioActive Nutritional, Inc.

1803 N. Wickham Rd.

Melbourne, FL 32935

bioactivenutritional.com

Directions:

Mix 3 parts water to one part juice, add 6 drops Hydrate I 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.

Indications:

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

Active Ingredients:

Coffea Tosta 1X, Ginkgo Biloba 6X, Germanium Sesquioxide 8X, Silica 8X.

Inactive Ingredients:

Celandine (Leaf, Stem, Flower) Chelidonium Majus, Beet (Root) Beta Vulgaris, Blessed Thistle (Leaf, Stem, Flower) Cnicus Benedictus, Boldo (Leaf) Peumus Boldus, Dandelion (Root) Taraxacum Officinale, Parsley (Leaf) Petroselinum Crispum, Demineralized Water, 25% Ethanol.

Package Label Display:

BIOActive Nutritional

HYDRATE I

HOMEOPATHIC

2 FL OZ (60 ml)

Keep Out of Reach of Children:

​Keep out of reach of children.​ In case of overdose, get medical help or contact Poison Control Center right away.


Structured Label Content

Warnings: (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.

Questions: (QUESTIONS:)

Distributed by:

BioActive Nutritional, Inc.

1803 N. Wickham Rd.

Melbourne, FL 32935

bioactivenutritional.com

Directions: (DIRECTIONS:)

Mix 3 parts water to one part juice, add 6 drops Hydrate I 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.

Indications: (INDICATIONS:)

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

Active Ingredients: (ACTIVE INGREDIENTS:)

Coffea Tosta 1X, Ginkgo Biloba 6X, Germanium Sesquioxide 8X, Silica 8X.

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Celandine (Leaf, Stem, Flower) Chelidonium Majus, Beet (Root) Beta Vulgaris, Blessed Thistle (Leaf, Stem, Flower) Cnicus Benedictus, Boldo (Leaf) Peumus Boldus, Dandelion (Root) Taraxacum Officinale, Parsley (Leaf) Petroselinum Crispum, Demineralized Water, 25% Ethanol.

Package Label Display: (PACKAGE LABEL DISPLAY:)

BIOActive Nutritional

HYDRATE I

HOMEOPATHIC

2 FL OZ (60 ml)

Keep Out of Reach of Children: (KEEP OUT OF REACH OF CHILDREN:)

​Keep out of reach of children.​ In case of overdose, get medical help or contact Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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