Drug Facts:

Drug Facts:
SPL v4
SPL
SPL Set ID 2d3657d9-d4f4-426c-b381-dbfde9b8e2cd
Route
ORAL
Published
Effective Date 2023-09-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Coffea Arabica Seed, Roasted (1 [hp_X]) Avena Sativa Flowering Top (3 [hp_X]) Equisetum Hyemale Whole (6 [hp_X]) Hypericum Perforatum Whole (8 [hp_X]) Ginkgo Germanium Sesquioxide Silicon Dioxide
Inactive Ingredients
Chelidonium Majus Whole Beet Centaurea Benedicta Peumus Boldus Leaf Taraxacum Officinale Root Parsley Water Alcohol

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2013-02-18

Description

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


Medication Information

Description

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

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, Avena Sativa 3X, Equisetum Hyemale 3X, Hypericum Perforatum 3X, Ginkgo Biloba 6X, Germanium Sesquioxide 8X, Silicea 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 II

HOMEOPATHIC

2 FL OZ  (60 ml)

Keep Out of Reach of Children:

In case of overdose, get medical help or contact a 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 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 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.

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, Avena Sativa 3X, Equisetum Hyemale 3X, Hypericum Perforatum 3X, Ginkgo Biloba 6X, Germanium Sesquioxide 8X, Silicea 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 II

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 a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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