The following Structured Product Label (SPL) was submitted to the FDA by Apotheca Company for the product Rehydrate (NDC 57520-0421). 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 otc - active ingredient, otc - purpose, warnings, dosage & administration, inactive ingredient, otc - keep out of reach of children, indications & usage, otc - questions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
ACTIVE INGREDIENTS: Avena sativa 3X, Equisetum hyemale 4X, Hypericum perforatum 6X, Ulmus fulva 6X, Glycyrrhiza glabra 12X, Pueraria lobata 12X, Wildbad aqua 6C, Carlsbad aqua 12C, ATP (adenosine triphosphate) 30C, Germanium sesquioxide 30C, Hydrogen 30C, Oxygen 30C, Wiesbaden aqua 30C.
INDICATIONS: To aid with proper hydration.
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: One drop per ounce of pure water. Consult a physician for use in children under 12 years of age.
INACTIVE INGREDIENTS: Demineralized water, Ethanol 9%, Glycerin, Proprietary blend of Beet (Root), Blessed Thistle (Aerial Parts), Boldo (Leaf), Celandine (Aerial Parts), Dandelion (Root), Parsley (Leaf).
KEEP OUT OF REACH OF CHILDREN. In case of overdose, get medical help or contact a Poison Control Center right away.
INDICATIONS: To aid with proper hydration.
MFG. FOR:
ParaDocs All Natural Inc.
5333 N. Dixie Hwy.ReHydrate
Homeopathic
2 FL OZ (60 ml)
Rehydrate (Mm1)
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