Hydrate Liquid
FDA Label NDC 43857-0080

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Bioactive Nutritional, Inc. for the product Hydrate (NDC 43857-0080). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients:, indications:, warnings:, directions:, inactive ingredients:, keep out of reach of children:, questions:, package label display:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

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.

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 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:

Celandine (aerial parts) Chelidonium majus, Beet (root) Beta vulgaris, Blessed Thistle (aerial parts) Cnicus benedictus, Boldo (leaf) Peumus boldus, Dandelion (root) Taraxacum officinale, and Parsley (leaf) Petroselinum crispum, 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.

Questions:

Distributed by:
BioActive Nutritional, Inc.
1803 N. Wickham Rd.
Melbourne, FL 32935
bioactivenutritional.com

Package Label Display:

BIOActive Nutritional

HYDRATE II

HOMEOPATHIC

2 FL OZ  (60 ml)

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